Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005062
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2000-04-06
Brief Title:
Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation PCI in Limited Small Cell Lung Cancer Complete Responders
Status:
COMPLETED
Status Verified Date:
2014-03
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 and prevent the spread of cancer to the brain It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain
PURPOSE This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission
PURPOSE This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission
Detailed Description:
OBJECTIVES
Compare high-dose versus standard-dose prophylactic cranial radiotherapy in terms of the incidence of brain metastases and overall and disease free survival at 2 years in patients with limited stage small cell lung cancer in complete remission
Evaluate the quality of life and late sequelae in this patient population treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center age 60 and under vs over 60 and interval between the start of induction therapy and date of randomization 90 days or less vs 91-180 days vs more than 180 days Patients are randomized into one of two treatment arms according to the prophylactic cranial radiotherapy dose
Arm I Patients receive standard-dose prophylactic cranial radiotherapy 10 fractions12 days
Arm II Patients receive high-dose prophylactic cranial radiotherapy administered over 16 or 24 days based on the choice of their treatment center
18 fractions24 days conventional radiotherapy OR
24 fractions16 days accelerated hyperfractionated radiotherapy Patients with isolated brain failure may undergo further radiotherapy
Quality of life is assessed prior to randomization at 6 months at 1 year and then annually thereafter
Patients are followed at least every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 700 patients will be accrued for this study within 3 years
Compare high-dose versus standard-dose prophylactic cranial radiotherapy in terms of the incidence of brain metastases and overall and disease free survival at 2 years in patients with limited stage small cell lung cancer in complete remission
Evaluate the quality of life and late sequelae in this patient population treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center age 60 and under vs over 60 and interval between the start of induction therapy and date of randomization 90 days or less vs 91-180 days vs more than 180 days Patients are randomized into one of two treatment arms according to the prophylactic cranial radiotherapy dose
Arm I Patients receive standard-dose prophylactic cranial radiotherapy 10 fractions12 days
Arm II Patients receive high-dose prophylactic cranial radiotherapy administered over 16 or 24 days based on the choice of their treatment center
18 fractions24 days conventional radiotherapy OR
24 fractions16 days accelerated hyperfractionated radiotherapy Patients with isolated brain failure may undergo further radiotherapy
Quality of life is assessed prior to randomization at 6 months at 1 year and then annually thereafter
Patients are followed at least every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 700 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-08004 | None | None | None |
| FRE-IGR-PCI-99 | None | None | None |
| EU-99051 | None | None | None |
| FRE-IFCT-9901 | None | None | None |
| FRE-IGR-PCI99-EULINT1 | None | None | None |
| EORTC-22003 | None | None | None |