Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003235
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase III Trial of Induction Paclitaxel and Carboplatin Followed By Standard Radiotherapy 64 Gy7 Weeks vs Hyperfractionated Accelerated Radiotherapy HART 576 Gy25 Weeks For Patients With Unresectable Stage IIIA and IIIB Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one drug with either standard radiation therapy or radiation therapy given at different times may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and carboplatin plus either standard radiation therapy or radiation therapy given at different times in treating patients with stage III non-small cell lung cancer that cannot be surgically removed
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and carboplatin plus either standard radiation therapy or radiation therapy given at different times in treating patients with stage III non-small cell lung cancer that cannot be surgically removed
Detailed Description:
OBJECTIVES I Determine response rates duration of response and survival of patients with unresectable or regionally advanced M0 stage IIIA or IIIB non-small cell lung carcinoma treated with induction paclitaxel and carboplatin followed by conventional vs accelerated radiation II Evaluate the patterns of local and distant failure for patients treated with these regimens
OUTLINE Patients are stratified by histology squamous vs nonsquamous performance status 0 vs 1 disease stage IIIA vs IIIB and response to induction chemotherapy initial response vs no response All patients receive induction therapy consisting of paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on days 1 and 22 Treatment repeats every 42 days for 2 courses Patients whose disease has not progressed outside the thorax are then randomized to 1 of 2 treatment arms Arm I Patients receive standard radiotherapy once a day 5 days a week for 6-7 weeks Arm II Patients receive hyperfractionated accelerated radiotherapy 3 times daily 5 days a week over 25 weeks Each fraction is separated by a minimum of 4 hours Radiotherapy begins between days 43 and 50 Patients are followed at 1 month after radiotherapy then every 3 months for 2 years every 6 months for the next 3 years and annually thereafter
PROJECTED ACCRUAL Approximately 294 patients will be accrued for this study within 35 years
OUTLINE Patients are stratified by histology squamous vs nonsquamous performance status 0 vs 1 disease stage IIIA vs IIIB and response to induction chemotherapy initial response vs no response All patients receive induction therapy consisting of paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on days 1 and 22 Treatment repeats every 42 days for 2 courses Patients whose disease has not progressed outside the thorax are then randomized to 1 of 2 treatment arms Arm I Patients receive standard radiotherapy once a day 5 days a week for 6-7 weeks Arm II Patients receive hyperfractionated accelerated radiotherapy 3 times daily 5 days a week over 25 weeks Each fraction is separated by a minimum of 4 hours Radiotherapy begins between days 43 and 50 Patients are followed at 1 month after radiotherapy then every 3 months for 2 years every 6 months for the next 3 years and annually thereafter
PROJECTED ACCRUAL Approximately 294 patients will be accrued for this study within 35 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 |
|---|---|---|---|
| E2597 | None | None | None |