Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002840
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
1999-11-01
Brief Title:
Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
PHASE III STUDY OF ADJUVANT PROCARBAZINE CCNU AND VINCRISTINE CHEMOTHERAPY IN PATIENTS WITH HIGHLY ANAPLASTIC OLIGODENDROGLIOMA
Status:
COMPLETED
Status Verified Date:
2012-07
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 and may be an effective treatment for anaplastic oligodendroglioma Combining combination chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Randomized phase III trial to compare radiation therapy with and without combination chemotherapy in patients with resected anaplastic oligodendroglioma
PURPOSE Randomized phase III trial to compare radiation therapy with and without combination chemotherapy in patients with resected anaplastic oligodendroglioma
Detailed Description:
OBJECTIVES I Compare survival and time to first progression in patients with anaplastic oligodendroglioma treated with radiotherapy with or without adjuvant procarbazine lomustine and vincristine PCV following surgical resection II Investigate the effect of PCV on quality of life and neurologic function in these patients III Determine the toxicity of PCV in these patients IV Correlate chromosomal lesions 1p andor 19q 9p p53 loss and mutation amplification of chromosome 7 or loss of chromosome 10 with progression-free and overall survival in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to age extent of resection performance status prior surgery and participating center Patients are randomized to one of two treatment arms Arm I Within 4-6 weeks after surgery patients undergo radiotherapy over 7 weeks to the residual tumor volume Arm II Patients undergo radiotherapy as in arm I then begin chemotherapy within 4 weeks after the completion of radiotherapy Patients receive oral lomustine on day 1 oral procarbazine on days 8-21 and vincristine IV on days 8 and 29 Treatment repeats every 6 weeks in stable and responding patients for a total of 6 courses Patients with disease recurrence may receive 6 additional courses of chemotherapy as above or another modality at the investigators discretion Patients are followed every 3 months for 1 year and then every 6 months for survival
PROJECTED ACCRUAL A total of 350 patients will be accrued for this study within 4 years
OUTLINE This is a randomized multicenter study Patients are stratified according to age extent of resection performance status prior surgery and participating center Patients are randomized to one of two treatment arms Arm I Within 4-6 weeks after surgery patients undergo radiotherapy over 7 weeks to the residual tumor volume Arm II Patients undergo radiotherapy as in arm I then begin chemotherapy within 4 weeks after the completion of radiotherapy Patients receive oral lomustine on day 1 oral procarbazine on days 8-21 and vincristine IV on days 8 and 29 Treatment repeats every 6 weeks in stable and responding patients for a total of 6 courses Patients with disease recurrence may receive 6 additional courses of chemotherapy as above or another modality at the investigators discretion Patients are followed every 3 months for 1 year and then every 6 months for survival
PROJECTED ACCRUAL A total of 350 patients will be accrued for this study 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 |
|---|---|---|---|
| MRC-BR11 | None | None | None |
| EORTC-26951 | None | None | None |