Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028691
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2002-01-04
Brief Title:
Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma
Sponsor:
Commissie Voor Klinisch Toegepast Onderzoek
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Chlorambucil Versus 2x2 Gy Involved Field Radiotherapy in Stage IIIIV Previously Untreated Follicular Lymphoma Patients A Prospective Randomized Phase III Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2002-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage cancer cells It is not yet known if chlorambucil is more effective than radiation therapy in treating follicular lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of chlorambucil with that of radiation therapy in treating patients who have stage III or stage IV follicular lymphoma that has not been previously treated
PURPOSE Randomized phase III trial to compare the effectiveness of chlorambucil with that of radiation therapy in treating patients who have stage III or stage IV follicular lymphoma that has not been previously treated
Detailed Description:
OBJECTIVES
Compare the effect of chlorambucil vs involved-field radiotherapy on progression-free survival of patients with previously untreated stage III or IV follicular lymphoma
Compare the complete and partial remission rates and overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral chlorambucil on days 1-5 Treatment repeats every 4 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo radiotherapy on days 1 and 3 and days 15 and 17 for split course
Quality of life is assessed at baseline prior to course 3 6 and 8 arm I and then at 4-6 weeks after study
Patients are followed at 4-6 weeks 3-4 months arm I 3 months and 6 months arm II 11 12 15 18 and 21 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 444 patients 222 per treatment arm will be accrued for this study within 4 years
Compare the effect of chlorambucil vs involved-field radiotherapy on progression-free survival of patients with previously untreated stage III or IV follicular lymphoma
Compare the complete and partial remission rates and overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral chlorambucil on days 1-5 Treatment repeats every 4 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo radiotherapy on days 1 and 3 and days 15 and 17 for split course
Quality of life is assessed at baseline prior to course 3 6 and 8 arm I and then at 4-6 weeks after study
Patients are followed at 4-6 weeks 3-4 months arm I 3 months and 6 months arm II 11 12 15 18 and 21 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 444 patients 222 per treatment arm will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-20013 | None | None | None |
| CKVO-2001-01 | None | None | None |
| HOVON-47NHL | None | None | None |
| EU-20131 | None | None | None |
| HOVON-CKTO-2001-01 | None | None | None |