Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452881
Status:
UNKNOWN
Last Update Posted:
2010-10-25
First Post:
2007-03-27
Brief Title:
Adjuvant Gemcitabine Plus Oxaliplatin Versus Gemcitabine Plus Cisplatin for Completely Resected Stage IBIIIIIA NSCLC
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
A Randomized Phase II Study Adjuvant Gemcitabine And Oxaliplatin Versus Gemcitabine and Cisplatin for Completely Resected Stage IB II or IIIA Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2010-07
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:
Oxaliplatin has a more manageable toxicity profile than cisplatin with no renal toxicity and a lower incidence of hematological and gastrointestinal toxicities The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index Given the potential advantages of oxaliplatin and th finding that the addition of chemotherapy improves survival in the postoperative adjuvant setting we conduct a phase II trial to compare adjuvant gemcitabine-oxaliplatin with gemcitabine-cisplatin in patients with completely resected stage IB II or IIIA NSCLC
Detailed Description:
This study is a randomized phase II study Patients are randomized to 1 of 2 treatment arms patients receive adjuvant chemotherapy with gemcitabine-oxaliplatin or gemcitabine-cisplatin Chemotherapy should be started within 8 weeks after complete surgical resection Patients are followed every 3 months for 2 years every 6 months for 3 years
Gemcitabine-Oxaliplatin GemOx chemotherapy
Gemcitabine 1250 mgm2Oxaliplatin 85 mgm2 is given on day 1 and 15 q 4weeks maximum 4 cycles
Gemcitabine-Cisplatin GemCis chemotherapy
Gemcitabine 1250 mgm2 Cisplatin 40 mgm2 is given on day 1 and 15 q 4weeks maximum 4 cycles
Gemcitabine-Oxaliplatin GemOx chemotherapy
Gemcitabine 1250 mgm2Oxaliplatin 85 mgm2 is given on day 1 and 15 q 4weeks maximum 4 cycles
Gemcitabine-Cisplatin GemCis chemotherapy
Gemcitabine 1250 mgm2 Cisplatin 40 mgm2 is given on day 1 and 15 q 4weeks maximum 4 cycles
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