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

Sponsor

International Extranodal Lymphoma Study Group (IELSG) (Other)

Overall Status

Completed

CT.gov ID

NCT00210379

Collaborator

(none)

Enrollment

Location

75.9

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, B Cell	Drug: rituximab Drug: CHOP Drug: intrathecal methotrexate Procedure: radiotherapy	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2000

Actual Primary Completion Date :

Nov 1, 2004

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oncology Institute of Southern Switzerland (IOSI)	Bellinzona		Switzerland	6500

Sponsors and Collaborators

International Extranodal Lymphoma Study Group (IELSG)

Investigators

Study Chair: Andreas Sarris, MD, International Extranodal Lymphoma Study Group
Study Chair: Emanuele Zucca, MD, International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)
Study Chair: Mary Gospodarowicz, MD, Radiation Oncology. Princess Margareth Hospital. Toronto
Study Chair: Umberto Vitolo, MD, Hematology Division. Ospedale San Giovanni Battista. Torino