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

Primary Purpose

Lymphoma, B Cell

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
rituximab
CHOP
intrathecal methotrexate
radiotherapy
Sponsored by
International Extranodal Lymphoma Study Group (IELSG)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, B Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: age = 18 years. ECOG performance status 0-2 Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated 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. Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible. Adequate bone marrow reserve (ANC > 1.000/L, Plt > 100.000/L) Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography No previous therapy with monoclonal antibody anti-CD20. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent No other major life-threatening illnesses that may preclude chemotherapy 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informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice Exclusion Criteria: impairment of renal function (creatinine > 2 mg/dl) or liver function (bilirubin > 2 mg/dl) unless due to lymphoma involvement HIV positive patients evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer

Sites / Locations

  • Oncology Institute of Southern Switzerland (IOSI)

Outcomes

Primary Outcome Measures

Disease-free survival
Progression-free survival
Event-free survival

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
July 21, 2009
Sponsor
International Extranodal Lymphoma Study Group (IELSG)
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1. Study Identification

Unique Protocol Identification Number
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
International Extranodal Lymphoma Study Group (IELSG)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
CHOP
Intervention Type
Drug
Intervention Name(s)
intrathecal methotrexate
Intervention Type
Procedure
Intervention Name(s)
radiotherapy
Primary Outcome Measure Information:
Title
Disease-free survival
Title
Progression-free survival
Title
Event-free survival
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age = 18 years. ECOG performance status 0-2 Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated 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. Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible. Adequate bone marrow reserve (ANC > 1.000/L, Plt > 100.000/L) Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography No previous therapy with monoclonal antibody anti-CD20. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent No other major life-threatening illnesses that may preclude chemotherapy 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: impairment of renal function (creatinine > 2 mg/dl) or liver function (bilirubin > 2 mg/dl) unless due to lymphoma involvement HIV positive patients evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Sarris, MD
Organizational Affiliation
International Extranodal Lymphoma Study Group
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emanuele Zucca, MD
Organizational Affiliation
International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mary Gospodarowicz, MD
Organizational Affiliation
Radiation Oncology. Princess Margareth Hospital. Toronto
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Umberto Vitolo, MD
Organizational Affiliation
Hematology Division. Ospedale San Giovanni Battista. Torino
Official's Role
Study Chair
Facility Information:
Facility Name
Oncology Institute of Southern Switzerland (IOSI)
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.ielsg.org
Description
Click here for more information about this study

Learn more about this trial

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

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