Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003387
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
1999-11-01
Brief Title:
Carboplatin Paclitaxel and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Concurrent Carboplatin Paclitaxel and Radiation Therapy Versus Induction Carboplatin and Paclitaxel Followed by Concurrent Carboplatin Paclitaxel and Radiation Therapy for Patients With Unresectable Stage III Non-Small Cell Lung Cancer A Phase III Trial
Status:
COMPLETED
Status Verified Date:
2016-07
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 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 It is not yet known whether giving chemotherapy before combined chemotherapy and radiation therapy is more effective than combined chemotherapy and radiation therapy alone in treating patients with non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of carboplatin and paclitaxel followed by radiation therapy and chemotherapy with radiation therapy and chemotherapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed during surgery
PURPOSE Randomized phase III trial to compare the effectiveness of carboplatin and paclitaxel followed by radiation therapy and chemotherapy with radiation therapy and chemotherapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed during surgery
Detailed Description:
OBJECTIVES I Compare the effects of concurrent chemoradiotherapy utilizing carboplatin and paclitaxel with or without prior induction chemotherapy on overall response rate disease-free survival and overall survival in patients with unresectable stage III non-small cell lung cancer II Compare the effects of these treatments on locoregional vs distant failure in these patients III Compare the toxicity of these treatments in these patients
OUTLINE This is a randomized study Patients are stratified by measurable vs evaluable disease Patients are randomized to 1 of 2 treatment arms Arm I immediate concurrent chemoradiotherapy Patients receive IV paclitaxel over 1 hour followed by IV carboplatin over 30 minutes on day 1 and radiation therapy to the chest 5 times a week beginning on day 1 Treatment repeats weekly for a total of 7 courses Arm II induction chemotherapy followed by delayed concurrent chemoradiotherapy Patients receive IV paclitaxel over 3 hours followed by IV carboplatin over 30 minutes treatment repeats every 3 weeks for 2 courses Patients then receive 7 courses of concurrent chemoradiotherapy as in Arm I Total treatment time is 13 weeks Patients are followed every 2 months for 2 years then every 4 months for the next 2 years then annually thereafter
PROJECTED ACCRUAL A total of 360 patients will be accrued for this study within 3 years
OUTLINE This is a randomized study Patients are stratified by measurable vs evaluable disease Patients are randomized to 1 of 2 treatment arms Arm I immediate concurrent chemoradiotherapy Patients receive IV paclitaxel over 1 hour followed by IV carboplatin over 30 minutes on day 1 and radiation therapy to the chest 5 times a week beginning on day 1 Treatment repeats weekly for a total of 7 courses Arm II induction chemotherapy followed by delayed concurrent chemoradiotherapy Patients receive IV paclitaxel over 3 hours followed by IV carboplatin over 30 minutes treatment repeats every 3 weeks for 2 courses Patients then receive 7 courses of concurrent chemoradiotherapy as in Arm I Total treatment time is 13 weeks Patients are followed every 2 months for 2 years then every 4 months for the next 2 years then annually thereafter
PROJECTED ACCRUAL A total of 360 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CLB-39801 | None | None | None |
| CDR0000066383 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |