## Protocol Section
### Identification Module
**NCT ID:** NCT00093379

**Brief Title:** Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

**Official Title:** A Phase II Study of Capecitabine (Xeloda)/Oxaliplatin (Eloxatin) With Concomitant Radiotherapy (XRT), XELOX/RT in Squamous Cell Carcinoma of the Anal Canal

#### Organization Study ID Info
**ID:** 2003-0874
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**ID:** P30CA016672
**Link:** https://reporter.nih.gov/quickSearch/P30CA016672
**Type:** NIH
**Domain:** UT MD Anderson Cancer Center
**ID:** MDA-2003-0874
**Type:** OTHER
**ID:** SANOFI-MDA-2003-0874
**Domain:** NCI PDQ
**ID:** CDR0000380771
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2012-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-04-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-03-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-07

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-04-17

**Type:** ESTIMATED

**Results First Submit Date:** 2013-10-15

**Results First Submit QC Date:** 2014-03-12

#### Start Date
**Date:** 2004-04

**Status Verified Date:** 2023-03

#### Study First Post Date
**Date:** 2004-10-08
**Type:** ESTIMATED
**Study First Submit Date:** 2004-10-06
**Study First Submit QC Date:** 2004-10-07
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Capecitabine may stop the growth of tumor cells by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Capecitabine and oxaliplatin may make tumor cells more sensitive to radiation therapy. Combining capecitabine and oxaliplatin with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with stage II or stage III anal cancer.

**Detailed Description:** OBJECTIVES:

Primary

* Determine time to treatment failure in patients with stage II-IIIB squamous cell carcinoma of the anal canal treated with capecitabine, oxaliplatin, and radiotherapy (i.e. Capecitabine (Xeloda)/Oxaliplatin (Eloxatin) With Concomitant Radiotherapy (XRT) shortened to XELOX/XRT).
* Determine the toxic effects of this regimen in these patients.

Secondary

* Determine the complete response rate in patients treated with this regimen.
* Determine 2-year local regional control in patients treated with this regimen.
* Determine 2-year colostomy-free survival in patients treated with this regimen.
* Determine 2-year median overall survival in patients treated with this regimen.
* Determine 2-year progression-free survival in patients treated with this regimen.

OUTLINE: Patients receive oral capecitabine\* twice daily on days 1-2, 6-10, 20-24, 27-31, and 41-42, and undergo radiotherapy\* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Patients also receive oxaliplatin intravenous (IV) over 2 hours on days 1, 8, 22, and 29. Treatment continues in the absence of disease progression or unacceptable toxicity.

NOTE: \*Patients with T3-4 lesions also receive oral capecitabine twice daily and undergo radiotherapy once daily on days 43 and 44.

Patients are followed at 4-6 and 12 weeks and then periodically thereafter.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.

### Conditions Module

**Conditions:**

- Anal Cancer

**Keywords:**

- stage II anal cancer

- stage IIIA anal cancer

- stage IIIB anal cancer

- squamous cell carcinoma of the anus

- Capecitabine

- Xeloda

- Oxaliplatin

- Eloxatin

- Radiotherapy

- XRT

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.

**Intervention Names:**

- Drug: Capecitabine

- Drug: Oxaliplatin

- Radiation: Radiation Therapy (XRT)

**Label:** Capecitabine + Oxaliplatin + XRT

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Capecitabine + Oxaliplatin + XRT

**Description:** 825 mg/m\^2 orally twice a day (BID), Mon-Fri during weeks 1, 2, 4, and 5.

**Name:** Capecitabine

**Other Names:**

- Xeloda

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Capecitabine + Oxaliplatin + XRT

**Description:** 50 mg/m\^2 by vein (IV) over 2 hours on days 1, 8, 22, and 29.

**Name:** Oxaliplatin

**Other Names:**

- Eloxatin

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Capecitabine + Oxaliplatin + XRT

**Description:** Undergo radiotherapy\* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. \*Patients with T3-4 lesions undergo radiotherapy once daily on days 43 and 44.

**Name:** Radiation Therapy (XRT)

**Other Names:**

- XRT

- RT

- Radiotherapy

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Description:** Treatment failure defined as: Biopsy proven residual disease identified 12 -14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence.

**Measure:** 2 Year Failure Free Survival

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** Response determined by computed tomography (CT)/magnetic resonance imaging (MRI), digital rectal examination, and proctoscopy, and a biopsy performed for clinical suspicion of residual or progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) where evaluation of target lesions Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

**Measure:** Number of Participants With Complete Response at 2 Years

**Time Frame:** 2 Years

**Description:** Colostomy-free survival reported as number of participants who did not develop local recurrence or require salvage resection with colostomy.

**Measure:** Number of Participants With 2-year Colostomy-Free Survival

**Time Frame:** 2 Years with median study follow up of 19 months

**Measure:** 2-year Local Regional Control

**Time Frame:** 2 Years

**Measure:** 2-Year Median Overall Survival

**Time Frame:** 2 Years

**Measure:** Number of Participants With Progression-Free Survival at 2-Year

**Time Frame:** 2 Years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Previously untreated patients with histologically proven squamous cell carcinoma of the anal canal.
2. American Joint Committee on Cancer (AJCC) stage II-IIIB (TX 1-4, NX, MO).
3. Age \>/= 16 yrs old.
4. Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) 0-1.
5. Adequate organ function including: Absolute neutrophil Count (ANC) \>/= 1,500/uL, Platelets \>/= 100,000/uL, Total bilirubin \</= 1.5 \* upper limit of normal (ULN), aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) \</= 3 \* ULN, Creatinine \</= 1.5mg/dL or Creatinine Clearance (CrCL) \>/= 50 cc/min.
6. Patients may have measurable or non-measurable disease. Patients with measurable disease, as defined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, have at least one lesion that can be accurately measured in at least one dimension with longest diameter to be recorded \>/= 20 mm using conventional techniques or \>/= 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). Lesions seen on colonoscopy or barium studies are not considered measurable lesions.
7. A negative pregnancy test in all women of child-bearing potential, within two weeks of initiating treatment.
8. The effects of oxaliplatin and capecitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because cytotoxic agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
9. Ability to understand and the willingness to sign the written informed consent/authorization document.

Exclusion Criteria:

1. Prior chemotherapy with oxaliplatin, capecitabine, or 5-fluorouracil.
2. Prior radiation to the pelvis.
3. Prior surgery for anal cancer excluding prior biopsy.
4. Known history of dihydropyrimidine (DPD) deficiency.
5. Known history of hypersensitivity to platinum-containing compounds.
6. Peripheral neuropathy of \>/= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) 3.0.
7. Calculated creatinine clearance (CrCl) \< 50 cc/min.
8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit adherence with study requirements.
9. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation.
10. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with oxaliplatin or capecitabine, breast feeding should be discontinued.
11. Because of the known interaction of capecitabine and coumadin, patients taking coumadin will be ineligible. Patients will be requested to discontinue coumadin and utilize Lovenox if agreeable. Patients must have discontinued coumadin for 7 days before initiating therapy.
12. No prior malignancies (excluding non-melanomatous skin neoplasms) over the past 5 years.
13. HIV-positive patients receiving combination anti-retroviral therapy are excluded from this study because of possible pharmacokinetic interactions with capecitabine or oxaliplatin. This exclusion is for patient safety since patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, and because very few HIV-positive anal canal cancer patients are seen at this institution. This hinders us from accruing enough patients to adequately test the safety of this regimen in this population.
14. Patients with symptomatic pulmonary fibrosis.

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Houston

**Country:** United States

**Facility:** M. D. Anderson Cancer Center at University of Texas

**State:** Texas

**Zip:** 77030-4009

#### Overall Officials

**Official 1:**

**Affiliation:** M.D. Anderson Cancer Center

**Name:** Cathy Eng, MD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** M.D. Anderson Cancer Center

**Name:** Christopher H. Crane, MD

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Eng C, Jacome AA, Das P, Chang GJ, Rodriguez-Bigas M, Skibber JM, Wolff RA, Qiao W, Xing Y, Sethi S, Ohinata A, Crane CH. A Phase II Study of Capecitabine/Oxaliplatin With Concurrent Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Anal Canal. Clin Colorectal Cancer. 2019 Dec;18(4):301-306. doi: 10.1016/j.clcc.2019.06.003. Epub 2019 Jul 2.

**PMID:** 31350201

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012004

- Term: Rectal Neoplasms

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000001004

- Term: Anus Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5550

- Name: Carcinoma, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: M4321

- Name: Anus Neoplasms

- Relevance: HIGH

- As Found: Anal Cancer

- ID: M14846

- Name: Rectal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4320

- Name: Anus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T362

- Name: Anal Cancer

- Relevance: HIGH

- As Found: Anal Cancer

### Condition Browse Module - Meshes

- ID: D000001005

- Term: Anus Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M377

- Name: Capecitabine

- Relevance: HIGH

- As Found: Function

- ID: M1674

- Name: Oxaliplatin

- Relevance: HIGH

- As Found: Outcomes

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069287

- Term: Capecitabine

- ID: D000077150

- Term: Oxaliplatin

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Capecitabine + Oxaliplatin + XRT

**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.

**ID:** EG000

**Other Num Affected:** 20

**Other Num at Risk:** 20

**Serious Number Affected:** 20

**Serious Number At Risk:** 20

**Title:** Capecitabine + Oxaliplatin + XRT

**Frequency Threshold:** 5

#### Other Events

**Term:** Allergic Reaction Including Drug Fever

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Alopecia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Increased Alanine aminotransferase (ALT, SGPT)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Anorexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Increased Aspartate aminotransferase (AST, SGOT)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Elevated Bilirubin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Bloody Stool

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Blurred Vision

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Bowel Movement, Changes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Blood urea nitrogen (BUN) Increase

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Burn

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** CTCAE (3.0)

**Term:** Cold Intolerance

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Cystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dermatitis (Chemoradiation)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dermatitis (Radiation)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dermatology/Skin (Other)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dry Mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dysuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Fever Without Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Flatulence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Gastritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Gastrointestinal (Other)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hand-Foot Syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Elevated Hemoglobin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** GI Hemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Hemorrhage, GI (Anus): 1 participant Hemorrhage, GI (Rectum): 3 participants

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hot Flashes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hyperpigmentation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hypoalbuminemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hypocalcemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hypokalemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hypomagnesemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hyponatremia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hypophosphatemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Infection (Other)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Infection Clinical with Grade 3-4 ANC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Infection with Grade 3-4 Absolute Neutrophil Count (ANC); Urinary Tract, Vagina

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Infection with Normal ANC

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Urinary Tract, Vagina, Vulva

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Lymphopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Metabolic Problem

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Mucositis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Muscle Cramps

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Musculoskeletal Issue (Other)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Neurological Issues (Other)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Neuropathy: Cranial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Cn X Motor-Palate, Pharynx, Larynx

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Increased Neutrophils (Absolute neutrophil count (ANC)/Absolute Granulocyte Count (AGC)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Abdomen, Anus, Chest Wall, Eye, Head/Headache, Muscle, Neck, Perineum, Rectum, Tumor, Urethra, Rectal and other areas.

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Proctitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Rash Dermatitis (Radiation)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Rash/Desquamation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Rectal Bleeding

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Renal/Genitourinary (Other)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Rhinorrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Rigors/Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Sinus Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Sore Throat

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Stricture/Stenosis, GI (Rectum)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Sweating

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Taste Alteration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Telangiectasia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Ulcer, GI (Rectum)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Vaginal Bleeding

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Vaginal Discharge

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Vaginal Dryness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Vaginal Stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Vaginitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Watery Eye

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Weight Loss

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Yeast Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

#### Serious Events

**Term:** •Increased Aspartate aminotransferase (AST, SGOT)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Term:** Allergic Reaction Including Drug Fever

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Term:** Dermatitis (Chemoradiation)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Term:** Dermatitis (Radiation)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 20

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 20

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Term:** Hemoglobin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Term:** Lymphopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 20

**Time Frame:** 5 years and 9 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Units:** Participants

### Group

**ID:** BG000

**Title:** Capecitabine + Oxaliplatin + XRT

**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 39

**Upper Limit:** 66

**Value:** 55

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** CR_Study_Registration@mdanderson.org
**Organization:** The University of Texas (UT) MD Anderson Cancer Center
**Title:** Cathy Eng, MD/ Professor
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
#### Outcome Measure 4
#### Outcome Measure 5
#### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Treatment failure defined as: Biopsy proven residual disease identified 12 -14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 2 years
**Title:** 2 Year Failure Free Survival
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
**ID:** OG000
**Title:** Capecitabine + Oxaliplatin + XRT
#### Outcome Measure 2
**Description:** Response determined by computed tomography (CT)/magnetic resonance imaging (MRI), digital rectal examination, and proctoscopy, and a biopsy performed for clinical suspicion of residual or progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) where evaluation of target lesions Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
**Parameter Type:** NUMBER
**Population Description:** Three (3) participants were not evaluable for response.
**Reporting Status:** POSTED
**Time Frame:** 2 Years
**Title:** Number of Participants With Complete Response at 2 Years
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
**ID:** OG000
**Title:** Capecitabine + Oxaliplatin + XRT
#### Outcome Measure 3
**Description:** Colostomy-free survival reported as number of participants who did not develop local recurrence or require salvage resection with colostomy.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 2 Years with median study follow up of 19 months
**Title:** Number of Participants With 2-year Colostomy-Free Survival
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
**ID:** OG000
**Title:** Capecitabine + Oxaliplatin + XRT
#### Outcome Measure 4
**Reporting Status:** NOT_POSTED
**Time Frame:** 2 Years
**Title:** 2-year Local Regional Control
**Type:** SECONDARY
#### Outcome Measure 5
**Reporting Status:** NOT_POSTED
**Time Frame:** 2 Years
**Title:** 2-Year Median Overall Survival
**Type:** SECONDARY
#### Outcome Measure 6
**Reporting Status:** NOT_POSTED
**Time Frame:** 2 Years
**Title:** Number of Participants With Progression-Free Survival at 2-Year
**Type:** SECONDARY
### Participant Flow Module
#### Group
**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy (XRT) once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor.
**ID:** FG000
**Title:** Capecitabine + Oxaliplatin + XRT
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Recruitment Details:** The recruitment period: April 16, 2004 to May 12, 2009. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
**Has Results:** True