Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002569
Status:
COMPLETED
Last Update Posted:
2018-06-18
First Post:
1999-11-01
Brief Title:
Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase III Intergroup Randomized Comparison of Radiation Alone vs Pre-Radiation Chemotherapy for Pure and Mixed Anaplastic Oligodendrogliomas
Status:
COMPLETED
Status Verified Date:
2018-06
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients who have anaplastic oligodendroglioma
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients who have anaplastic oligodendroglioma
Detailed Description:
OBJECTIVES
Compare the overall survival and time to tumor progression in patients with unifocal or multifocal supratentorial pure or mixed anaplastic oligodendroglioma treated with radiotherapy with or without procarbazine lomustine and vincristine PCV
Compare the toxic effects of these 2 regimens in these patients
Compare the quality of life and neurologic function of patients treated with these 2 regimens
OUTLINE This is a randomized study Patients are stratified by age under 50 vs 50 and over Karnofsky performance status 60-70 vs 80-100 and tumor grade moderately vs highly anaplastic Within 8 weeks after diagnostic surgery patients are randomized to 1 of 2 treatment arms
Arm I Within 2 weeks after randomization patients receive oral lomustine on day 1 oral procarbazine on days 8-21 and vincristine IV on days 8 and 29 PCV Treatment continues every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Beginning within 6 weeks after day 29 of course 4 patients undergo radiotherapy 5 days a week for 56 weeks followed by boost radiotherapy 5 days a week for 1 week
Arm II Within 2 weeks after randomization patients undergo radiotherapy as in arm I
Quality of life is assessed at baseline at time of CT or MRI scans during study and every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter after completion of study therapy
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 292 patients 146 per arm will be accrued for this study within 54 years
Compare the overall survival and time to tumor progression in patients with unifocal or multifocal supratentorial pure or mixed anaplastic oligodendroglioma treated with radiotherapy with or without procarbazine lomustine and vincristine PCV
Compare the toxic effects of these 2 regimens in these patients
Compare the quality of life and neurologic function of patients treated with these 2 regimens
OUTLINE This is a randomized study Patients are stratified by age under 50 vs 50 and over Karnofsky performance status 60-70 vs 80-100 and tumor grade moderately vs highly anaplastic Within 8 weeks after diagnostic surgery patients are randomized to 1 of 2 treatment arms
Arm I Within 2 weeks after randomization patients receive oral lomustine on day 1 oral procarbazine on days 8-21 and vincristine IV on days 8 and 29 PCV Treatment continues every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Beginning within 6 weeks after day 29 of course 4 patients undergo radiotherapy 5 days a week for 56 weeks followed by boost radiotherapy 5 days a week for 1 week
Arm II Within 2 weeks after randomization patients undergo radiotherapy as in arm I
Quality of life is assessed at baseline at time of CT or MRI scans during study and every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter after completion of study therapy
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 292 patients 146 per arm will be accrued for this study within 54 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 |
|---|---|---|---|
| INT-0149 | None | None | None |
| CDR0000063603 | None | None | None |
| CAN-NCIC-CE2 | None | None | None |
| E-R9402 | None | None | None |
| NCCTG-927252 | None | None | None |
| SWOG-9402 | None | None | None |