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

Phase 2

Completed

• Conditions: Lymphoma, B Cell

• Registration Number: NCT00210379
• Lead Sponsor: International Extranodal Lymphoma Study Group (IELSG)

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-11
• Primary Completion: 2004-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2007-03
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-21
• Last Update Posted: 2009-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Event-free survival
Progression-free survival
Disease-free survival

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oncology Institute of Southern Switzerland (IOSI); 🇨🇭 Bellinzona, Switzerland