Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002576
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Older Patients With Intermediate- or High-Grade Non-Hodgkins Lymphoma
Sponsor:
Cancer Research Campaign Clinical Trials Centre
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A RANDOMIZED PROSPECTIVE TRIAL OF CHOP VERSUS MCOP IN ELDERLY PATIENTS WITH INTERMEDIATE AND HIGH GRADE NON-HODGKINS LYMPHOMA AGED 65 YEARS AND OVER
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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-Hodgkins lymphoma
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-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Assess the treatment-related neurologic and hematologic toxicities of patients aged 65 years and over with intermediate- or high-grade non-Hodgkins 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 CTXDOXVCRPRDL CTX Cyclophosphamide NSC-26271 DHAD Mitoxantrone NSC-301739 DOX Doxorubicin NSC-123127 MCOP DHADCTXVCRPRDL 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
OUTLINE Randomized study The following acronyms are used CHOP CTXDOXVCRPRDL CTX Cyclophosphamide NSC-26271 DHAD Mitoxantrone NSC-301739 DOX Doxorubicin NSC-123127 MCOP DHADCTXVCRPRDL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN39268693 | REGISTRY | ISRCTN International Standard Randomised Controlled Trial Number Register | None |
| CDR0000063660 | REGISTRY | None | None |
| EU-93028 | None | None | None |