Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062322
Status:
COMPLETED
Last Update Posted:
2010-02-12
First Post:
2003-06-05
Brief Title:
Neoadjuvant Chemoradiotherapy Followed By Surgery in Treating Patients With Limited-Stage Small Cell Lung Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase I Study of Preoperative ChemoRadiation Concurrent IrinotecanCisplatinRT Followed by Surgery in Limited Stage Small Cell Lung Cancer SCLC-LS
Status:
COMPLETED
Status Verified Date:
2010-02
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 irinotecan and cisplatin 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 Irinotecan and cisplatin may also make the tumor cells more sensitive to radiation therapy Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE This phase I trial is studying the side effects of neoadjuvant radiation therapy given together with irinotecan and cisplatin followed by surgery in treating patients with limited-stage small cell lung cancer
PURPOSE This phase I trial is studying the side effects of neoadjuvant radiation therapy given together with irinotecan and cisplatin followed by surgery in treating patients with limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the safety and feasibility of neoadjuvant chemoradiotherapy with irinotecan and cisplatin followed by surgery in patients with limited stage small cell lung cancer
Determine the pathologic complete response rate of patients treated with this regimen
Correlate the level of vascular endothelial growth factor with treatment response and disease outcome in patients treated with this regimen
Correlate genetic polymorphisms in cytochrome P450 1A1 glutathione S-transferase M1 and P1 myeloperoxidase and NADpH quinone oxidoreductase with treatment response and disease outcome in patients treated with this regimen
OUTLINE This is a pilot study
Induction chemotherapy Patients receive cisplatin IV over 1 hour on day 1 and irinotecan IV over 90 minutes on days 1 and 8
Chemoradiotherapy Beginning on day 21 patients receive chemoradiotherapy comprising radiotherapy once daily 5 days a week for 4 weeks and then twice daily for 4 days Patients also receive cisplatin IV and irinotecan IV over 30-60 minutes once weekly concurrently with radiotherapy Treatment continues in the absence of disease progression or unacceptable toxicity
At the completion of chemoradiotherapy patients are evaluated for surgery Patients who are candidates for surgery receive one additional course of cisplatin IV and irinotecan IV Patients who are not candidates for surgery receive radiotherapy twice daily for 4 days and cisplatin IV and irinotecan IV as in chemoradiotherapy
Surgery Approximately 2-4 weeks after the last dose of chemotherapy patients undergo surgery
Patients are followed every 4 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Determine the safety and feasibility of neoadjuvant chemoradiotherapy with irinotecan and cisplatin followed by surgery in patients with limited stage small cell lung cancer
Determine the pathologic complete response rate of patients treated with this regimen
Correlate the level of vascular endothelial growth factor with treatment response and disease outcome in patients treated with this regimen
Correlate genetic polymorphisms in cytochrome P450 1A1 glutathione S-transferase M1 and P1 myeloperoxidase and NADpH quinone oxidoreductase with treatment response and disease outcome in patients treated with this regimen
OUTLINE This is a pilot study
Induction chemotherapy Patients receive cisplatin IV over 1 hour on day 1 and irinotecan IV over 90 minutes on days 1 and 8
Chemoradiotherapy Beginning on day 21 patients receive chemoradiotherapy comprising radiotherapy once daily 5 days a week for 4 weeks and then twice daily for 4 days Patients also receive cisplatin IV and irinotecan IV over 30-60 minutes once weekly concurrently with radiotherapy Treatment continues in the absence of disease progression or unacceptable toxicity
At the completion of chemoradiotherapy patients are evaluated for surgery Patients who are candidates for surgery receive one additional course of cisplatin IV and irinotecan IV Patients who are not candidates for surgery receive radiotherapy twice daily for 4 days and cisplatin IV and irinotecan IV as in chemoradiotherapy
Surgery Approximately 2-4 weeks after the last dose of chemotherapy patients undergo surgery
Patients are followed every 4 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| FCCC-02613 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |