## Protocol Section
### Identification Module
**NCT ID:** NCT00005979

**Brief Title:** Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer

**Official Title:** Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence

#### Organization Study ID Info
**ID:** CDR0000067967
#### Organization
**Class:** OTHER
**Full Name:** UNICANCER
#### Secondary ID Infos
**ID:** FRE-FNCLCC-ACCORD-2
**ID:** FFCD-9802
**ID:** EU-20014
### Status Module
#### Completion Date
**Date:** 2007-09-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-02-17

**Type:** ACTUAL

**Last Update Submit Date:** 2021-02-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2005-09-26

**Type:** ACTUAL

#### Start Date
**Date:** 1998-07-22

**Type:** ACTUAL

**Status Verified Date:** 2021-02

#### Study First Post Date
**Date:** 2003-01-27
**Type:** ESTIMATED
**Study First Submit Date:** 2000-07-05
**Study First Submit QC Date:** 2003-01-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Federation Francophone de Cancerologie Digestive

#### Lead Sponsor

**Class:** OTHER

**Name:** UNICANCER

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer.

**Detailed Description:** OBJECTIVES:

* Compare the effect of leucovorin calcium and fluorouracil with or without irinotecan on the 3 year survival rate and overall survival of patients with resected node positive colon cancer at high risk of recurrence.
* Compare toxicities of these regimens in these patients.
* Compare quality of life of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, disease type (occlusion vs perforation vs N2 only), delay between surgery and chemotherapy (28 days or less vs over 28 days), and age (under 65 vs 65 and over). Patients are randomized to one of two treatment arms.

* Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2.
* Arm II: Patients receive irinotecan IV over 90 minutes on day 1 followed by leucovorin calcium and fluorouracil as in arm I.

Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before treatment, after 6 and 12 courses, and then at 1 year.

Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study within 3 years.

### Conditions Module

**Conditions:**

- Colorectal Cancer

**Keywords:**

- stage III colon cancer

- adenocarcinoma of the colon

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Primary Purpose:** TREATMENT

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** FOLFIRI regimen

**Type:** DRUG

#### Intervention 2

**Name:** fluorouracil

**Type:** DRUG

#### Intervention 3

**Name:** irinotecan hydrochloride

**Type:** DRUG

#### Intervention 4

**Name:** leucovorin calcium

**Type:** DRUG

### Eligibility Module

**Eligibility Criteria:** DISEASE CHARACTERISTICS:

* Histologically proven stage III adenocarcinoma of the colon that has been curatively resected within past 42 days
* No metastatic disease
* Node positive

  * No more than 4 nodes affected (Tx, N2, M0) AND/OR
  * N1 or N2 with perforation and/or occlusion
* No prior rectal cancer within 10 cm of anal margin or that was treated with preoperative radiotherapy
* No prior inflammatory disease of the intestine

PATIENT CHARACTERISTICS:

Age:

* 18 to 75

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Neutrophil count at least 2,000/mm3
* Platelet count at least 100,000/mm3

Hepatic:

* Bilirubin less than 1.25 times upper limit of normal (ULN)
* SGOT and SGPT less than 3 times ULN
* Alkaline phosphatase less than 3 times ULN

Renal:

* Not specified

Cardiovascular:

* No myocardial infarction within past 6 months
* No insufficient cardiac function

Other:

* No other serious medical illness
* No active infection
* No other malignancy except skin cancer or carcinoma in situ of the cervix
* No psychological or social condition that would preclude study
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics

Surgery:

* See Disease Characteristics
* No prior extensive intestinal resection

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Angers

**Country:** France

**Facility:** Centre Paul Papin

**Zip:** 49036

**Location 2:**

**City:** Bayonne

**Country:** France

**Facility:** Clinique St. Etienne

**Zip:** 64100

**Location 3:**

**City:** Bordeaux

**Country:** France

**Facility:** Institut Bergonie

**Zip:** 33076

**Location 4:**

**City:** Bourg-En-Bresse

**Country:** France

**Facility:** Centre Hospitalier de Fleyriat

**Zip:** 01012

**Location 5:**

**City:** Bourgoin-Jallieu

**Country:** France

**Facility:** Centre Hospitalier de Bourgoin - Jallieu

**Zip:** 38300

**Location 6:**

**City:** Brive

**Country:** France

**Facility:** Centre Hospitalier General

**Zip:** 19101

**Location 7:**

**City:** Caen

**Country:** France

**Facility:** Centre Regional Francois Baclesse

**Zip:** 14076

**Location 8:**

**City:** Creteil

**Country:** France

**Facility:** Centre Hospitalier Universitaire Henri Mondor

**Zip:** 94010

**Location 9:**

**City:** Dijon

**Country:** France

**Facility:** Faculte de Medecine

**Zip:** 21033

**Location 10:**

**City:** Dijon

**Country:** France

**Facility:** Hopital Du Bocage

**Zip:** 21034

**Location 11:**

**City:** Forbach

**Country:** France

**Facility:** Centre Hospitalier Maie Madeleine

**Zip:** 57600

**Location 12:**

**City:** Lyon

**Country:** France

**Facility:** Centre Leon Berard

**Zip:** 69008

**Location 13:**

**City:** Marseille

**Country:** France

**Facility:** Institut J. Paoli and I. Calmettes

**Zip:** 13273

**Location 14:**

**City:** Montpellier

**Country:** France

**Facility:** Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

**Zip:** 34298

**Location 15:**

**City:** Nantes-Saint Herblain

**Country:** France

**Facility:** CRLCC Nantes - Atlantique

**Zip:** 44805

**Location 16:**

**City:** Orleans

**Country:** France

**Facility:** CHR D'Orleans - Hopital de la Source

**Zip:** 45067

**Location 17:**

**City:** Reims

**Country:** France

**Facility:** Institut Jean Godinot

**Zip:** 51056

**Location 18:**

**City:** Reims

**Country:** France

**Facility:** St Joseph's Medical Center

**Zip:** 51056

**Location 19:**

**City:** Reims

**Country:** France

**Facility:** Centre Hospitalier Universitaire

**Zip:** 51092

**Location 20:**

**City:** Rennes

**Country:** France

**Facility:** Centre Eugene Marquis

**Zip:** 35064

**Location 21:**

**City:** Rouen

**Country:** France

**Facility:** Hopital Charles Nicolle

**Zip:** 76031

**Location 22:**

**City:** Saint Cloud

**Country:** France

**Facility:** Centre Rene Huguenin

**Zip:** 92210

**Location 23:**

**City:** Strasbourg

**Country:** France

**Facility:** Hopitaux Universitaire de Strasbourg

**Zip:** 67091

**Location 24:**

**City:** Tarbes

**Country:** France

**Facility:** Centre Hospitalier de Tarbes

**Zip:** 65013

**Location 25:**

**City:** Toulouse

**Country:** France

**Facility:** Institut Claudius Regaud

**Zip:** 31052

**Location 26:**

**City:** Valence

**Country:** France

**Facility:** Centre Hospitalier Valence

**Zip:** 26000

**Location 27:**

**City:** Vandoeuvre-les-Nancy

**Country:** France

**Facility:** Centre Alexis Vautrin

**Zip:** 54511

**Location 28:**

**City:** Vannes

**Country:** France

**Facility:** Centre Hospitalier P. Chubert

**Zip:** 56260

**Location 29:**

**City:** Vichy

**Country:** France

**Facility:** Centre Hospitalier Regionale de Vichy

**Zip:** 03201

**Location 30:**

**City:** Villejuif

**Country:** France

**Facility:** Institut Gustave Roussy

**Zip:** F-94805

#### Overall Officials

**Official 1:**

**Affiliation:** Institut du Cancer de Montpellier - Val d'Aurelle

**Name:** Marc Ychou, MD, PhD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Federation Francophone de Cancerologie Digestive

**Name:** Jean Faivre

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Ychou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, Viret F, Becouarn Y, Bouche O, Gamelin E, Ducreux M, Conroy T, Seitz JF, Bedenne L, Kramar A. A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802). Ann Oncol. 2009 Apr;20(4):674-80. doi: 10.1093/annonc/mdn680. Epub 2009 Jan 29.

**PMID:** 19179549

**Citation:** Cote JF, Kirzin S, Kramar A, Mosnier JF, Diebold MD, Soubeyran I, Thirouard AS, Selves J, Laurent-Puig P, Ychou M. UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan. Clin Cancer Res. 2007 Jun 1;13(11):3269-75. doi: 10.1158/1078-0432.CCR-06-2290. Epub 2007 May 17.

**PMID:** 17510208

## Derived Section

### Condition Browse Module - Ancestors

- 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: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M6338

- Name: Colonic Neoplasms

- Relevance: HIGH

- As Found: Colon Cancer

- 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: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003110

- Term: Colonic Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000059004

- Term: Topoisomerase I Inhibitors

- ID: D000059003

- Term: Topoisomerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000000931

- Term: Antidotes

- ID: D000020011

- Term: Protective Agents

- ID: D000014803

- Term: Vitamin B Complex

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M6191

- Name: Leucovorin

- Relevance: HIGH

- As Found: Stem Cell

- ID: M8600

- Name: Fluorouracil

- Relevance: HIGH

- As Found: According

- ID: M29233

- Name: Levoleucovorin

- Relevance: HIGH

- As Found: Root

- ID: M1671

- Name: Irinotecan

- Relevance: HIGH

- As Found: CT scan

- ID: M5381

- Name: Calcium

- Relevance: HIGH

- As Found: Radiation

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M29349

- Name: Topoisomerase I Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4250

- Name: Antidotes

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: T447

- Name: Folinic Acid

- Relevance: HIGH

- As Found: Root

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002955

- Term: Leucovorin

- ID: D000005472

- Term: Fluorouracil

- ID: D000077146

- Term: Irinotecan

- ID: D000002118

- Term: Calcium

- ID: D000058766

- Term: Levoleucovorin

### Misc Info Module

- Version Holder: 2024-05-24
