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

NCT00210379 | Completed Phase 2

• 1 other identifier: IELSG10
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphoma, B Cell

Outcome Measures

Primary Outcomes (3)

• Disease-free survival

• Progression-free survival

• Event-free survival

Secondary Outcomes (1)

• 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

Interventions

rituximab DRUG

CHOP DRUG

intrathecal methotrexate DRUG

radiotherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice

You may not qualify if:

• 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

Sponsors & Collaborators

• International Extranodal Lymphoma Study Group (IELSG): lead

Study Sites (1)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, 6500, Switzerland

Location

Related Links

• Click here for more information about this study

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Rituximab; Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: November 1, 2000
• Primary Completion: November 1, 2004
• Study Completion: March 1, 2007
• Last Updated: July 22, 2009

Record last verified: 2009-07

Locations

CH (1)