Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072527
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2003-11-04
Brief Title:
Cisplatin and Irinotecan Followed by Carboplatin Etoposide and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Induction CisplatinIrinotecan Followed By Combination Carboplatin Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer A Phase II Study
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 such as cisplatin irinotecan carboplatin and etoposide 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 Phase II trial to study the effectiveness of cisplatin and irinotecan followed by carboplatin etoposide and radiation therapy in treating patients who have limited-stage small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of cisplatin and irinotecan followed by carboplatin etoposide and radiation therapy in treating patients who have limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of cisplatin and irinotecan followed by carboplatin etoposide and radiotherapy in terms of 2-year survival in patients with limited stage small cell lung cancer
Secondary
Determine the overall response rate overall survival and failure-free survival of patients treated with this regimen
Determine the response rate in patients treated with induction therapy comprising irinotecan and cisplatin
Determine the toxicity and tolerability of this regimen in these patients
OUTLINE This is a multicenter study
Induction therapy Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
Consolidation therapy Immediately after the completion of induction therapy patients receive carboplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity
Radiotherapy Beginning on day 1 of consolidation therapy patients undergo chest radiotherapy daily 5 days a week for 6-7 weeks
After the completion of consolidation therapy patients who achieve a complete remission or very good partial remission may undergo prophylactic radiotherapy to the brain
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study within 15-24 months
Primary
Determine the efficacy of cisplatin and irinotecan followed by carboplatin etoposide and radiotherapy in terms of 2-year survival in patients with limited stage small cell lung cancer
Secondary
Determine the overall response rate overall survival and failure-free survival of patients treated with this regimen
Determine the response rate in patients treated with induction therapy comprising irinotecan and cisplatin
Determine the toxicity and tolerability of this regimen in these patients
OUTLINE This is a multicenter study
Induction therapy Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
Consolidation therapy Immediately after the completion of induction therapy patients receive carboplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity
Radiotherapy Beginning on day 1 of consolidation therapy patients undergo chest radiotherapy daily 5 days a week for 6-7 weeks
After the completion of consolidation therapy patients who achieve a complete remission or very good partial remission may undergo prophylactic radiotherapy to the brain
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study within 15-24 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 |
|---|---|---|---|
| CDR0000339871 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |