Combination Chemotherapy in Treating Older Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00002576|
Recruitment Status : Completed
First Posted : May 24, 2004
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: vincristine sulfate||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Official Title:||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)|
|Study Start Date :||November 1992|
|Study Completion Date :||January 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002576
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Study Chair:||Eric Michael Bessell, MD, PhD, FRCP, FRCR||Nottingham City Hospital|