Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004259
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2000-01-28
Brief Title:
Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Randomized Study Phase I Closed of Radiation Therapy and Temozolomide Versus Radiation Therapy and Nitrosourea for Anaplastic Astrocytoma And Mixed Anaplastic Oligoastrocytoma Astrocytoma Dominant
Status:
COMPLETED
Status Verified Date:
2019-08
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy such as temozolomide carmustine and lomustine use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared to radiation therapy and carmustine or lomustine in treating patients with anaplastic astrocytoma or mixed gliomas
PURPOSE This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared to radiation therapy and carmustine or lomustine in treating patients with anaplastic astrocytoma or mixed gliomas
Detailed Description:
OBJECTIVES
Compare the overall survival and time to tumor progression in patients with anaplastic astrocytoma or mixed gliomas treated with radiotherapy combined with temozolomide vs carmustine or lomustine vs temozolomide and carmustine arm discontinued as of 81502
Compare the relative toxic effects of these regimens in these patients
Correlate molecular analyses with overall survival and time to tumor progression in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 50 vs 50 and over Karnofsky performance status 60-80 vs 90-100 and prior surgery biopsy only vs resection
Phase I
Pilot Arms I and II Prior to initiating the randomization to 1 of 3 treatment arms in phase III Patients are accrued to Arm III regimen to determine tolerability
Phase III
Patients are randomized to 1 of 2 treatment arms 3rd arm was dropped
Arm I Patients undergo radiotherapy 5 days a week for 6 weeks Patients receive oral temozolomide on days 1-5 of the first week of radiotherapy Chemotherapy repeats every 4 weeks for a total of 12 courses
Arm II Patients undergo radiotherapy as in arm I Patients receive carmustine IV or lomustine IV over 1-2 hours on days 1-3 of the first week of radiotherapy and a second course on days 56-58 Chemotherapy repeats every 8 weeks for a total of 6 courses
Arm III dropped did not open Patients undergo radiotherapy as in arm I Patients receive carmustine IV or lomustine IV over 3 hours on day 5 and oral temozolomide 2 hours after completion of carmustine or lomustine infusion on days 1-5 of the first week of radiotherapy Combination chemotherapy repeats every 8 weeks for 6 courses
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Phase I 30 patients Phase III 454 patients 227 per treatment arm within 4 years
Compare the overall survival and time to tumor progression in patients with anaplastic astrocytoma or mixed gliomas treated with radiotherapy combined with temozolomide vs carmustine or lomustine vs temozolomide and carmustine arm discontinued as of 81502
Compare the relative toxic effects of these regimens in these patients
Correlate molecular analyses with overall survival and time to tumor progression in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 50 vs 50 and over Karnofsky performance status 60-80 vs 90-100 and prior surgery biopsy only vs resection
Phase I
Pilot Arms I and II Prior to initiating the randomization to 1 of 3 treatment arms in phase III Patients are accrued to Arm III regimen to determine tolerability
Phase III
Patients are randomized to 1 of 2 treatment arms 3rd arm was dropped
Arm I Patients undergo radiotherapy 5 days a week for 6 weeks Patients receive oral temozolomide on days 1-5 of the first week of radiotherapy Chemotherapy repeats every 4 weeks for a total of 12 courses
Arm II Patients undergo radiotherapy as in arm I Patients receive carmustine IV or lomustine IV over 1-2 hours on days 1-3 of the first week of radiotherapy and a second course on days 56-58 Chemotherapy repeats every 8 weeks for a total of 6 courses
Arm III dropped did not open Patients undergo radiotherapy as in arm I Patients receive carmustine IV or lomustine IV over 3 hours on day 5 and oral temozolomide 2 hours after completion of carmustine or lomustine infusion on days 1-5 of the first week of radiotherapy Combination chemotherapy repeats every 8 weeks for 6 courses
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Phase I 30 patients Phase III 454 patients 227 per treatment arm within 4 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 |
|---|---|---|---|
| NCCTG-RTOG-9813 | None | None | None |
| CDR0000067512 | None | None | None |
| ECOG-R9813 | None | None | None |