Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030810
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2002-02-14
Brief Title:
Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer NSCLC Patients With Operable Stage IIIB Disease A Prospective Phase II Trial
Status:
COMPLETED
Status Verified Date:
2019-05
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 before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the feasibility and efficacy of sequential neoadjuvant docetaxel cisplatin and radiotherapy followed by surgery in patients with operable stage IIIB non-small cell lung cancer
Determine the rate of event-free survival at 1 year in patients treated with this regimen
Determine the operability and complete resection rate in patients treated with this regimen
Determine the postoperative 30-day mortality in patients treated with this regimen
Determine the response rate failure pattern and overall survival in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 Treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity
Beginning 3 weeks after the last chemotherapy dose patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5 8-12 and 15-19
Patients undergo surgery within 3-4 weeks after completion of radiotherapy
Patients are followed at 1 month and then every 3 months thereafter
PROJECTED ACCRUAL A total of 15-46 patients will be accrued for this study
Determine the feasibility and efficacy of sequential neoadjuvant docetaxel cisplatin and radiotherapy followed by surgery in patients with operable stage IIIB non-small cell lung cancer
Determine the rate of event-free survival at 1 year in patients treated with this regimen
Determine the operability and complete resection rate in patients treated with this regimen
Determine the postoperative 30-day mortality in patients treated with this regimen
Determine the response rate failure pattern and overall survival in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 Treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity
Beginning 3 weeks after the last chemotherapy dose patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5 8-12 and 15-19
Patients undergo surgery within 3-4 weeks after completion of radiotherapy
Patients are followed at 1 month and then every 3 months thereafter
PROJECTED ACCRUAL A total of 15-46 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-20137 | None | None | None |