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

NCT ID: NCT00002576

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-11-30

Study Completion Date

2001-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphoma

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

mitoxantrone hydrochloride

Intervention Type DRUG

prednisolone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research Campaign Clinical Trials Centre

OTHER

Sponsor Role lead

Principal Investigators

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Eric Michael Bessell, MD, PhD, FRCP, FRCR

Role: STUDY_CHAIR

Nottingham City Hospital

Locations

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Nottingham City Hospital NHS Trust

Nottingham, England, United Kingdom

Site Status

Countries

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United Kingdom

References

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Sattler FR, Mert M, Sankaranarayanan I, Mack WJ, Galle-Treger L, Gonzalez E, Baronikian L, Lee K, Jahani PS, Hodis HN, Dieli-Conwright C, Akbari O. Feasibility of quantifying change in immune white cells in abdominal adipose tissue in response to an immune modulator in clinical obesity. PLoS One. 2020 Sep 3;15(9):e0237496. doi: 10.1371/journal.pone.0237496. eCollection 2020.

Reference Type DERIVED
PMID: 32881912 (View on PubMed)

Other Identifiers

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CDR0000063660

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-93028

Identifier Type: -

Identifier Source: secondary_id

ISRCTN39268693

Identifier Type: REGISTRY

Identifier Source: secondary_id

CRC-TU-NH3003

Identifier Type: -

Identifier Source: org_study_id