Ignite Creation Date:
2024-05-05 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003375
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
1999-11-01
Brief Title:
Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Study of Observation in Favorable Low-Grade Glioma and a Phase II Study of Radiation With or Without PCV Chemotherapy in Unfavorable Low-Grade Glioma
Status:
COMPLETED
Status Verified Date:
2024-07
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 use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether radiation therapy combined with chemotherapy is more effective than radiation therapy alone in treating patients with low-grade glioma
PURPOSE Phase IIIII trial to evaluate observation and to compare the effectiveness of radiation therapy with or without combination chemotherapy in treating patients with low-grade glioma
PURPOSE Phase IIIII trial to evaluate observation and to compare the effectiveness of radiation therapy with or without combination chemotherapy in treating patients with low-grade glioma
Detailed Description:
OBJECTIVES
Identify the overall survival of low-risk adult patients with supratentorial low-grade glioma who are observed postoperatively
Compare the overall survival of high-risk adult patients with supratentorial low-grade glioma who receive postoperative external beam radiotherapy with or without procarbazine lomustine and vincristine PCV chemotherapy
Compare the toxic effects of postoperative radiotherapy with or without PCV chemotherapy in patients with unfavorable low-grade glioma
OUTLINE This is a randomized study Patients are stratified according to tumor subtype astrocytoma mixed-astro dominant or equal astrooligo mix vs oligodendroglioma mixed-oligo dominant age younger than 40 vs at least 40 Karnofsky performance status 60-80 vs 90-100 and contrast enhancement on preoperative scan present vs absent Patients with low-risk disease younger than 40 years old whose tumors have been surgically removed are assigned to arm I Patients with high-risk disease at least 40 years old or who have had incomplete tumor removal are randomized to arm II or III
Arm I low-risk patients Patients are observed Patients may receive treatment if tumor recurs
Arm II high-risk patients Patients receive daily external beam radiotherapy 5 days a week for 6 weeks
Arm III high-risk patients Patients receive radiotherapy as in arm II followed by chemotherapy 1 month later Chemotherapy consists of oral lomustine on day 1 vincristine IV on days 8 and 29 and oral procarbazine on days 8-21 Each course of chemotherapy lasts 8 weeks Patients may receive up to 6 courses of chemotherapy
Patients are followed every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 252 patients will be accrued within 525 years
Identify the overall survival of low-risk adult patients with supratentorial low-grade glioma who are observed postoperatively
Compare the overall survival of high-risk adult patients with supratentorial low-grade glioma who receive postoperative external beam radiotherapy with or without procarbazine lomustine and vincristine PCV chemotherapy
Compare the toxic effects of postoperative radiotherapy with or without PCV chemotherapy in patients with unfavorable low-grade glioma
OUTLINE This is a randomized study Patients are stratified according to tumor subtype astrocytoma mixed-astro dominant or equal astrooligo mix vs oligodendroglioma mixed-oligo dominant age younger than 40 vs at least 40 Karnofsky performance status 60-80 vs 90-100 and contrast enhancement on preoperative scan present vs absent Patients with low-risk disease younger than 40 years old whose tumors have been surgically removed are assigned to arm I Patients with high-risk disease at least 40 years old or who have had incomplete tumor removal are randomized to arm II or III
Arm I low-risk patients Patients are observed Patients may receive treatment if tumor recurs
Arm II high-risk patients Patients receive daily external beam radiotherapy 5 days a week for 6 weeks
Arm III high-risk patients Patients receive radiotherapy as in arm II followed by chemotherapy 1 month later Chemotherapy consists of oral lomustine on day 1 vincristine IV on days 8 and 29 and oral procarbazine on days 8-21 Each course of chemotherapy lasts 8 weeks Patients may receive up to 6 courses of chemotherapy
Patients are followed every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 252 patients will be accrued within 525 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 |
|---|---|---|---|
| SWOG-R9802 | None | None | None |
| CDR0000066367 | None | None | None |
| E-R9802 | None | None | None |
| NCCTG-R9802 | None | None | None |