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

Study Overview
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Brief Summary
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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

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

Conditions
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Lymphoma, B Cell

Intervention / Treatment
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* Drug: rituximab
* Drug: CHOP
* Drug: intrathecal methotrexate
* Procedure: radiotherapy


Participation Criteria
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Eligibility Criteria
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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informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice Exclusion Criteria: impairment of renal function (creatinine 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rituximab|nan|
|Drug: CHOP|nan|
|Drug: intrathecal methotrexate|nan|
|Procedure: radiotherapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  |  | 
| Progression-free survival |  |  | 
| Event-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |