Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182819
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2005-09-15
Brief Title:
Radiation Therapy or Temozolomide in Treating Patients With Gliomas
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss A Phase III Study
Status:
COMPLETED
Status Verified Date:
2016-10
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 kill tumor cells Drugs used in chemotherapy such as temozolomide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas
PURPOSE This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas
PURPOSE This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas
Detailed Description:
OBJECTIVES
Primary
Compare the progression-free survival of patients with low-grade gliomas treated with radiotherapy vs temozolomide
Secondary
Compare the overall survival of patients treated with these regimens
Determine whether the incidence of late toxicity can be decreased in patients who are randomized to receive temozolomide
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to participating center chromosome 1p status deleted vs normal vs undeterminable contrast enhancement on MRI yes vs no age 40 years vs 40 years and WHO performance status 0 or 1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy once daily 5 days a week for a total of 28 fractions ie 5½ weeks
Arm II Patients receive oral temozolomide once daily on days 1-21 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then every 3 months until disease progression
After completion of study treatment patients are followed every 6 months for survival
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A minimum of 699 patients a total of 466 randomized 233 per treatment arm will be accrued for this study within 5 years
Primary
Compare the progression-free survival of patients with low-grade gliomas treated with radiotherapy vs temozolomide
Secondary
Compare the overall survival of patients treated with these regimens
Determine whether the incidence of late toxicity can be decreased in patients who are randomized to receive temozolomide
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to participating center chromosome 1p status deleted vs normal vs undeterminable contrast enhancement on MRI yes vs no age 40 years vs 40 years and WHO performance status 0 or 1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy once daily 5 days a week for a total of 28 fractions ie 5½ weeks
Arm II Patients receive oral temozolomide once daily on days 1-21 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then every 3 months until disease progression
After completion of study treatment patients are followed every 6 months for survival
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A minimum of 699 patients a total of 466 randomized 233 per treatment arm will be accrued for this study within 5 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-BR13 | EudraCT Number | None | None |
| 2004-002714-11 | EUDRACT_NUMBER | None | None |
| CAN-NCIC-CE5 | None | None | None |
| TROG 0601 | None | None | None |