Combination Chemotherapy in Treating Older Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||August 6, 2013|
|Start Date ICMJE||November 1992|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00002576 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Combination Chemotherapy in Treating Older Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma|
|Official Title ICMJE||A RANDOMIZED PROSPECTIVE TRIAL OF CHOP VERSUS MCOP IN ELDERLY PATIENTS WITH INTERMEDIATE AND HIGH GRADE NON-HODGKIN'S LYMPHOMA (AGED 65 YEARS AND OVER)|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of cyclophosphamide, vincristine, and prednisolone, with either mitoxantrone or doxorubicin in treating patients with intermediate- or high-grade non-Hodgkin's lymphoma.
OBJECTIVES: I. Assess the treatment-related neurologic and hematologic toxicities of patients aged 65 years and over with intermediate- or high-grade non-Hodgkin's lymphoma randomized to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) vs. MCOP (mitoxantrone, cyclophosphamide, vincristine, prednisolone). II. Compare the survival rate in these patients.
OUTLINE: Randomized study. The following acronyms are used: CHOP CTX/DOX/VCR/PRDL CTX Cyclophosphamide, NSC-26271 DHAD Mitoxantrone, NSC-301739 DOX Doxorubicin, NSC-123127 MCOP DHAD/CTX/VCR/PRDL PRDL Prednisolone, NSC-9900 VCR Vincristine, NSC-67574 Arm I: 4-Drug Combination Chemotherapy. CHOP. Arm II: 4-Drug Combination Chemotherapy. MCOP.
PROJECTED ACCRUAL: A total of 200 patients will be entered over approximately 5 years.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||200|
|Completion Date||January 2001|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically confirmed intermediate- or high-grade non- Hodgkin's lymphoma of the following types: Diffuse centroblastic Diffuse immunoblastic B- and T-cell lymphoblastic Peripheral T-cell (mixed or large cell) and Ki-1 No Stage IA (nonbulky) disease suitable for radiotherapy alone
PATIENT CHARACTERISTICS: Age: 65 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No severe ischemic heart disease No cardiomyopathy that would restrict doxorubicin use Other: No other serious medical conditions that would affect treatment outcome No prior malignancy except: Nonmelanomatous skin cancer Adequately treated in situ cervical cancer Sufficiently fit to receive treatment
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
|Ages||65 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United Kingdom|
|NCT Number ICMJE||NCT00002576|
|Other Study ID Numbers ICMJE||CRC-TU-NH3003, CDR0000063660, EU-93028, ISRCTN39268693|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Cancer Research Campaign Clinical Trials Centre|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||May 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP