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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2007-03-31

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

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Detailed Description

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Conditions

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Lymphoma, B Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rituximab

Intervention Type DRUG

CHOP

Intervention Type DRUG

intrathecal methotrexate

Intervention Type DRUG

radiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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 Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No