Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077220
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2004-02-10
Brief Title:
Paclitaxel Carboplatin and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomised Study Of Adjuvant Paclitaxel And Carboplatin TAXOL-PARAPLATINE With Concomittant Radiotherapy In Patients With Stage II or III Non-Metastatic Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 such as paclitaxel and carboplatin work in 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 together with radiation therapy is more effective with or without adjuvant chemotherapy in treating unresectable stage II or stage III non-small cell lung cancer
PURPOSE This randomized phase III trial is studying giving paclitaxel carboplatin and radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works compared to giving paclitaxel carboplatin and radiation therapy alone in treating patients with unresectable stage II or stage III non-small cell lung cancer
PURPOSE This randomized phase III trial is studying giving paclitaxel carboplatin and radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works compared to giving paclitaxel carboplatin and radiation therapy alone in treating patients with unresectable stage II or stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare the progression-free survival of patients with stage II or III unresectable non-small cell lung cancer treated with paclitaxel carboplatin and radiotherapy with or without adjuvant paclitaxel and carboplatin
Secondary
Compare the objective response rate in patients treated with these regimens
Compare the overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to radiotherapy regimen conformational vs nonconformational
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for up to 6 weeks Patients concurrently undergo radiotherapy 5 days a week for 7-75 weeks Three weeks after completion of chemoradiotherapy patients with stable or responding disease are randomized to 1 of 2 treatment arms
Arm I Patients undergo routine follow-up
Arm II Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for a maximum of 3 courses
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 390 patients will be accrued for this study within 3 years
Primary
Compare the progression-free survival of patients with stage II or III unresectable non-small cell lung cancer treated with paclitaxel carboplatin and radiotherapy with or without adjuvant paclitaxel and carboplatin
Secondary
Compare the objective response rate in patients treated with these regimens
Compare the overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to radiotherapy regimen conformational vs nonconformational
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for up to 6 weeks Patients concurrently undergo radiotherapy 5 days a week for 7-75 weeks Three weeks after completion of chemoradiotherapy patients with stable or responding disease are randomized to 1 of 2 treatment arms
Arm I Patients undergo routine follow-up
Arm II Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for a maximum of 3 courses
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 390 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 |
|---|---|---|---|
| EU-20330 | None | None | None |
| FRE-GERCOR-B00-1 | None | None | None |