Clinical trial NCT00210379: Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, B Cell
Lead sponsor: International Extranodal Lymphoma Study Group (IELSG)
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice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

Primary outcomes:
measure: Disease-free survival
measure: Progression-free survival
measure: Event-free survival
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland (IOSI)
Study officials:
affiliation: International Extranodal Lymphoma Study Group
name: Andreas Sarris, MD
role: STUDY_CHAIR
affiliation: International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)
name: Emanuele Zucca, MD
role: STUDY_CHAIR
affiliation: Radiation Oncology. Princess Margareth Hospital. Toronto
name: Mary Gospodarowicz, MD
role: STUDY_CHAIR
affiliation: Hematology Division. Ospedale San Giovanni Battista. Torino
name: Umberto Vitolo, MD
role: STUDY_CHAIR
References: