Trial | NCT00210379  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    64
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
Study Started
Nov 30
2000
Primary Completion
Nov 30
2004
Study Completion
Mar 31
2007
Last Update
Jul 22
2009
Estimate

Drug rituximab

Drug CHOP

Drug intrathecal methotrexate

Procedure radiotherapy

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informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice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
No Results Posted