Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006378
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2000-10-04
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Randomized Study of Taxol PACLITAXEL Paraplatin Carboplatin and Radiation Therapy for Locally Advanced Inoperable Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2014-01
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 chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of three different regimens of combining paclitaxel and carboplatin plus radiation therapy in treating patients who have stage III non-small cell lung cancer that cannot be removed during surgery
PURPOSE Randomized phase II trial to compare the effectiveness of three different regimens of combining paclitaxel and carboplatin plus radiation therapy in treating patients who have stage III non-small cell lung cancer that cannot be removed during surgery
Detailed Description:
OBJECTIVES I Compare survival of patients with stage IIIA or IIIB unresectable non-small cell lung cancer treated with one of three different combined modality regimens of paclitaxel carboplatin and radiotherapy II Compare the safety and toxicity of these treatment regimens in these patients III Compare the relapse free survival rate in these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to one of three treatment arms Arm I Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 every 3 weeks for 2 courses followed by radiotherapy 5 times a week for 7 weeks beginning on day 42 Arm II Patients receive paclitaxel and carboplatin as in arm I followed by radiotherapy 5 times a week paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 7 weeks beginning on day 42 Arm III Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly and radiotherapy 5 times a week for 7 weeks beginning on day 1 followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses beginning 3 weeks after concurrent chemotherapy and radiotherapy Patients are followed every 3 months for 2 years every 4 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 264 patients 88 per treatment arm will be accrued for this study within 20 months
OUTLINE This is a randomized multicenter study Patients are randomized to one of three treatment arms Arm I Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 every 3 weeks for 2 courses followed by radiotherapy 5 times a week for 7 weeks beginning on day 42 Arm II Patients receive paclitaxel and carboplatin as in arm I followed by radiotherapy 5 times a week paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 7 weeks beginning on day 42 Arm III Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly and radiotherapy 5 times a week for 7 weeks beginning on day 1 followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses beginning 3 weeks after concurrent chemotherapy and radiotherapy Patients are followed every 3 months for 2 years every 4 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 264 patients 88 per treatment arm will be accrued for this study within 20 months
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 |
|---|---|---|---|
| NCI-G00-1867 | None | None | None |
| CWRU-LAMP-1598 | None | None | None |
| ACR-427 | None | None | None |
| BMS-CWRU-LAMP-1598 | None | None | None |
| CWRU-099834 | None | None | None |