Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma
This study has been completed.
Sponsor:
International Extranodal Lymphoma Study Group (IELSG)
Information provided by:
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT00210379
First received: September 13, 2005
Last updated: July 21, 2009
Last verified: July 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma, B Cell |
Drug: rituximab Drug: CHOP Drug: intrathecal methotrexate Procedure: radiotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):
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
| Enrollment: | 64 |
| Study Start Date: | November 2000 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210379
Locations
| Switzerland | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | International Extranodal Lymphoma Study Group (IELSG), IELSG |
| ClinicalTrials.gov Identifier: | NCT00210379 History of Changes |
| Other Study ID Numbers: | IELSG10 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 21, 2009 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Methotrexate Rituximab Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013