Skip to main content
OpenTrials
Completed

NCT Number: NCT00002576

Combination Chemotherapy in Treating Older Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphoma Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Tumor Virus Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

Doxorubicin hydrochloride

Drug

mitoxantrone hydrochloride

Drug

Prednisolone

Drug

vincristine sulfate

Drug

Sponsors and collaborators

Lead sponsor

Cancer Research Campaign Clinical Trials Centre

Other

Registry information

Official study 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)

Important dates

Study start
1992
Study completion
2001
First posted
May 24, 2004
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.