## Protocol Section
### Identification Module
**NCT ID:** NCT00210379

**Brief Title:** Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma

**Official Title:** A Phase II Study of CHOP + Rituximab, With Intrathecal Methotrexate Followed by Radiotherapy in Patients With Primary Testicular Non-Hodgkin's Lymphoma

#### Organization Study ID Info
**ID:** IELSG10
#### Organization
**Class:** OTHER
**Full Name:** International Extranodal Lymphoma Study Group (IELSG)
### Status Module
#### Completion Date
**Date:** 2007-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-07-22

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-07-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2004-11

**Type:** ACTUAL

#### Start Date
**Date:** 2000-11

**Status Verified Date:** 2009-07

#### Study First Post Date
**Date:** 2005-09-21
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-13
**Study First Submit QC Date:** 2005-09-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** International Extranodal Lymphoma Study Group (IELSG)

#### Responsible Party

**Old Name Title:** International Extranodal Lymphoma Study Group (IELSG)

**Old Organization:** IELSG

### Description Module

**Brief Summary:** The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to assess the toxicity of this therapeutic strategy

### Conditions Module

**Conditions:**

- Lymphoma, B Cell

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 64

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** rituximab

**Type:** DRUG

#### Intervention 2

**Name:** CHOP

**Type:** DRUG

#### Intervention 3

**Name:** intrathecal methotrexate

**Type:** DRUG

#### Intervention 4

**Name:** radiotherapy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Disease-free survival

**Measure:** Progression-free survival

**Measure:** Event-free survival

#### Secondary Outcomes

**Measure:** Overall survival will be a secondary end-point because post-relapse therapy is not specified in this protocol and is expected to be highly variable

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. age = 18 years.
2. ECOG performance status 0-2
3. Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated
4. Ann Arbor stage IE or IIE. Bilateral testicular involvement at presentation will not be considered stage IV. In these patients the final Ann Arbor stage will be determined by the extent of nodal involvement.
5. Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
6. Adequate bone marrow reserve (ANC \> 1.000/L, Plt \> 100.000/L)
7. Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography
8. No previous therapy with monoclonal antibody anti-CD20.
9. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
10. No other major life-threatening illnesses that may preclude chemotherapy
11. Have given written informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice

Exclusion Criteria:

1. impairment of renal function (creatinine \> 2 mg/dl) or liver function (bilirubin \> 2 mg/dl) unless due to lymphoma involvement
2. HIV positive patients
3. evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bellinzona

**Country:** Switzerland

**Facility:** Oncology Institute of Southern Switzerland (IOSI)

**Zip:** 6500

#### Overall Officials

**Official 1:**

**Affiliation:** International Extranodal Lymphoma Study Group

**Name:** Andreas Sarris, MD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)

**Name:** Emanuele Zucca, MD

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Radiation Oncology. Princess Margareth Hospital. Toronto

**Name:** Mary Gospodarowicz, MD

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** Hematology Division. Ospedale San Giovanni Battista. Torino

**Name:** Umberto Vitolo, MD

**Role:** STUDY_CHAIR

### References Module

#### See Also Links

**Label:** Click here for more information about this study

**URL:** http://www.ielsg.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M18828

- Name: Lymphoma, B-Cell

- Relevance: HIGH

- As Found: Lymphoma, B-Cell

- ID: M11222

- Name: Lymphoma, Non-Hodgkin

- Relevance: HIGH

- As Found: Non-Hodgkin Lymphoma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T640

- Name: B-cell Lymphoma

- Relevance: HIGH

- As Found: Lymphoma, B-Cell

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000008228

- Term: Lymphoma, Non-Hodgkin

- ID: D000016393

- Term: Lymphoma, B-Cell

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000000020

- Term: Abortifacient Agents, Nonsteroidal

- ID: D000000019

- Term: Abortifacient Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000003879

- Term: Dermatologic Agents

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000005493

- Term: Folic Acid Antagonists

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000019384

- Term: Nucleic Acid Synthesis Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M11703

- Name: Methotrexate

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M373

- Name: Rituximab

- Relevance: HIGH

- As Found: Healthy

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M8619

- Name: Folic Acid Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: T447

- Name: Folinic Acid

- 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: D000069283

- Term: Rituximab

- ID: D000008727

- Term: Methotrexate

### Misc Info Module

- Version Holder: 2024-05-24
