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)
65 Years
N/A
Both
Lymphoma
Trial Information
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)
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Eric Michael Bessell, MD, PhD, FRCP, FRCR
Investigator Role:
Study Chair
Investigator Affiliation:
Nottingham City Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000063660
NCT ID:
NCT00002576
Start Date:
November 1992
Completion Date:
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
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