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Doxorubicin |
Adriamycin; Rubex |
Clinical Trial: Combination Chemotherapy in Treating Older Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
This study is no longer recruiting patients.
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 | Treatment or Intervention | Phase |
|---|---|---|
| Lymphoma | Drug: cyclophosphamide Drug: doxorubicin Drug: mitoxantrone Drug: prednisolone Drug: vincristine | Phase III |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of CHOP (CTX/DOX/VCR/PRDL) vs MCOP (DHAD/CTX/VCR/PRDL) in Patients Aged 65 Years and Over with Intermediate- or High-Grade non-Hodgkin's Lymphoma
Study start: 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.
PROTOCOL 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 above
Criteria
PROTOCOL ENTRY CRITERIA:
--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
--Prior/Concurrent Therapy--
- Biologic therapy: Not specified
- Chemotherapy: No prior chemotherapy
- Endocrine therapy: Not specified
- Radiotherapy: No prior radiotherapy
- Surgery: Not specified
--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
Location Information
United Kingdom, England
Nottingham City Hospital NHS Trust, Nottingham, England, NG5 1PB, United Kingdom
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002576
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Adriamycin (Drug Digest)
- Doxorubicin (Drug Digest)
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