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| Descriptive Information Fields | |||||
| Brief Title † | Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation | ||||
| Official Title † | A Phase III Study of Involved Field Radiation Therapy (IFRT) in Patients With Histologically Aggressive Non-Hodgkin's Lymphoma Following High Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation (ASCT) | ||||
| Brief Summary | RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if giving radiation therapy after stem cell transplantation is more effective than stem cell transplantation alone in treating relapsed or refractory non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma and have undergone autologous stem cell transplantation. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to response to pre-salvage chemotherapy (primary refractory disease vs relapse), response to post-salvage chemotherapy (complete/unconfirmed complete vs partial), and participating center. Within 6-8 weeks after completion of autologous hematopoietic stem cell transplantation, patients are randomized to 1 of 2 treatment arms.
Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years. PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 4.2 years. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Active Control | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Lymphoma | ||||
| Intervention † | Procedure: radiation therapy | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | |||||
| Start Date † | January 2001 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00031668 | ||||
| Organization ID | CDR0000069214 | ||||
| Secondary IDs †† | CAN-NCIC-LY8 | ||||
| Study Sponsor † | National Cancer Institute of Canada | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2002 | ||||
| First Received Date † | March 8, 2002 | ||||
| Last Updated Date | July 23, 2008 | ||||