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| Sponsor: | Cancer Research Campaign Clinical Trials Centre |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002576 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: vincristine sulfate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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) |
| Estimated Enrollment: | 200 |
| Study Start Date: | November 1992 |
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom, England | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Study Chair: | Eric Michael Bessell, MD, PhD, FRCP, FRCR | Nottingham City Hospital NHS Trust |
More Information
| Study ID Numbers: | CDR0000063660, CRC-TU-NH3003, EU-93028 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002576 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I adult diffuse mixed cell lymphoma stage I adult diffuse large cell lymphoma stage I adult immunoblastic large cell lymphoma stage I adult lymphoblastic lymphoma stage I adult Burkitt lymphoma stage II adult diffuse mixed cell lymphoma stage II adult diffuse large cell lymphoma stage II adult immunoblastic large cell lymphoma stage II adult lymphoblastic lymphoma stage II adult Burkitt lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III adult Burkitt lymphoma |
stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma contiguous stage II adult diffuse mixed cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma contiguous stage II adult Burkitt lymphoma contiguous stage II adult lymphoblastic lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult lymphoblastic lymphoma |
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Anti-Inflammatory Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Sensory System Agents Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Analgesics Lymphoma Alkylating Agents |
Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases Neoplasms Tubulin Modulators Prednisolone |
