Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398385
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2006-11-09
Brief Title:
Gemcitabine and Cisplatin Before or After Surgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Study of Preoperative Versus Postoperative Gemcitabine and Cisplatin for Patients With Stage IB-II Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2008-04
Last Known Status:
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 gemcitabine and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving chemotherapy after surgery may kill any tumor cells that remain after surgery It is not yet known whether giving chemotherapy before surgery is more effective than giving it after surgery in treating non-small cell lung cancer
PURPOSE This randomized phase II trial is studying gemcitabine and cisplatin to compare how well they work when given before or after surgery in treating patients with stage I or stage II non-small cell lung cancer
PURPOSE This randomized phase II trial is studying gemcitabine and cisplatin to compare how well they work when given before or after surgery in treating patients with stage I or stage II non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare the time to recurrence in patients with stage IB or II non-small cell lung cancer treated with neoadjuvant versus adjuvant gemcitabine hydrochloride and cisplatin
Secondary
Compare overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare quality of life of these patients
Compare the complete resection rate with and without neoadjuvant gemcitabine hydrochloride and cisplatin
OUTLINE This is a randomized study Patients are stratified by disease stage IB vs II and histology squamous cell carcinoma vs nonsquamous cell carcinoma Patients are randomized to 1 of 2 treatment arms
Arm I neoadjuvant chemotherapy Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 30 minutes on days 1 and 15 Treatment repeats every 4 weeks for up to 4 courses in the absence of disease recurrence or unacceptable toxicity Within 8 weeks after initiating course 4 of chemotherapy patients undergo complete surgical resection
Arm II adjuvant chemotherapy Patients undergo complete surgical resection Beginning within 8 weeks after complete surgical resection patients receive gemcitabine hydrochloride IV and cisplatin IV as in arm I
Quality of life is assessed at baseline and periodically for up to 5 years
After completion of study therapy patients are followed periodically for at least 5 years or until disease recurrence
PROJECTED ACCRUAL A total of 170 patients will be accrued for this study
Primary
Compare the time to recurrence in patients with stage IB or II non-small cell lung cancer treated with neoadjuvant versus adjuvant gemcitabine hydrochloride and cisplatin
Secondary
Compare overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare quality of life of these patients
Compare the complete resection rate with and without neoadjuvant gemcitabine hydrochloride and cisplatin
OUTLINE This is a randomized study Patients are stratified by disease stage IB vs II and histology squamous cell carcinoma vs nonsquamous cell carcinoma Patients are randomized to 1 of 2 treatment arms
Arm I neoadjuvant chemotherapy Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 30 minutes on days 1 and 15 Treatment repeats every 4 weeks for up to 4 courses in the absence of disease recurrence or unacceptable toxicity Within 8 weeks after initiating course 4 of chemotherapy patients undergo complete surgical resection
Arm II adjuvant chemotherapy Patients undergo complete surgical resection Beginning within 8 weeks after complete surgical resection patients receive gemcitabine hydrochloride IV and cisplatin IV as in arm I
Quality of life is assessed at baseline and periodically for up to 5 years
After completion of study therapy patients are followed periodically for at least 5 years or until disease recurrence
PROJECTED ACCRUAL A total of 170 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000516823 | REGISTRY | PDQ Physician Data Query | None |