Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039039
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2002-06-06
Brief Title:
Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Sponsor:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro Genoa Italy
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Study of Paclitaxel and Carboplatin or Cisplatin Followed by Radiotherapy With or Without Concurrent Paclitaxel in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2006-08
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 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 Drugs such as paclitaxel may make tumor cells more sensitive to radiation therapy It is not yet known if combination chemotherapy followed by radiation therapy is more effective with or without paclitaxel in treating unresectable stage III non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by radiation therapy with or without paclitaxel in treating patients who have unresectable stage III non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by radiation therapy with or without paclitaxel in treating patients who have unresectable stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the overall survival rate of patients with unresectable stage III non-small cell lung cancer treated with paclitaxel and carboplatin or cisplatin followed by radiotherapy with or without concurrent paclitaxel
Compare the 1-year survival rate and mean survival time in patients treated with these regimens
Compare the objective response rate and local control in patients treated with these regimens
Compare the tolerability of these regimens in these patients
Compare the safety profile and toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes or cisplatin IV on day 1 Treatment repeats every 21 days for 2 courses Patients then proceed to randomized treatment
Arm I Patients receive paclitaxel IV over 1 hour on day 1 and radiotherapy on days 1-5 of each week for 6 weeks
Arm II Patients receive radiotherapy 5 days a week for 7 weeks Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 300 patients 150 per treatment arm will be accrued for this study within 3 years
Compare the overall survival rate of patients with unresectable stage III non-small cell lung cancer treated with paclitaxel and carboplatin or cisplatin followed by radiotherapy with or without concurrent paclitaxel
Compare the 1-year survival rate and mean survival time in patients treated with these regimens
Compare the objective response rate and local control in patients treated with these regimens
Compare the tolerability of these regimens in these patients
Compare the safety profile and toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes or cisplatin IV on day 1 Treatment repeats every 21 days for 2 courses Patients then proceed to randomized treatment
Arm I Patients receive paclitaxel IV over 1 hour on day 1 and radiotherapy on days 1-5 of each week for 6 weeks
Arm II Patients receive radiotherapy 5 days a week for 7 weeks Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 300 patients 150 per treatment arm 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 |
|---|---|---|---|
| NCI-V01-1665 | None | None | None |
| INRC-PITCAP | None | None | None |
| EU-20202 | None | None | None |
| INRC-ITA | None | None | None |