Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003317
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Study of Surgical Resection and Chemotherapy Paclitaxel and Carboplatin With or Without Adjuvant Radiotherapy for Resected Stage IIIA Non-Small Cell Lung Cancer
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 Combining more than one drug may kill more tumor cells Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known if combination chemotherapy is more effective with or without radiation therapy for stage IIIA non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have stage IIIA non-small cell lung cancer that has been surgically removed
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have stage IIIA non-small cell lung cancer that has been surgically removed
Detailed Description:
OBJECTIVES I Compare the overall survival of surgically resected patients with limited stage IIIA non-small cell lung cancer who are treated by postoperative chemotherapy with or without adjuvant radiotherapy II Compare failure free survival of these patients III Describe the patterns of local and distant recurrence in these patients IV Determine the toxicities associated with chemotherapy with or without adjuvant radiotherapy in these patients
OUTLINE This is a randomized multicenter study Four to eight weeks after surgery all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1 22 43 and 64 Following completion of four courses of chemotherapy patients are randomized into one of two treatment arms
OUTLINE This is a randomized multicenter study Four to eight weeks after surgery all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1 22 43 and 64 Following completion of four courses of chemotherapy patients are randomized into one of two treatment arms
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 |
|---|---|---|---|
| CDR0000066266 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |