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

This study has been completed.
Sponsor:
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
  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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, B-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Methotrexate
Rituximab
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014