Viewing Study NCT00326378



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Last Modification Date: 2024-10-26 @ 9:24 AM
Study NCT ID: NCT00326378
Status: COMPLETED
Last Update Posted: 2015-06-08
First Post: 2006-05-15

Brief Title: Efficacy Study of Additional Chemotherapy After Concurrent Chemoradiation in Non-small Cell Lung Cancer
Sponsor: Samsung Medical Center
Organization: Samsung Medical Center

Study Overview

Official Title: A Multinational Multicenter Phase III Open Randomized Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-small Cell Lung Cancer CCheIN
Status: COMPLETED
Status Verified Date: 2012-11
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: Non-Small Cell Lung CancerNSCLC is the leading cause of death in Korean men after stomach cancer Surgical resection plays a main role for curative treatment However less than 20 of the NSCLC patients have been found in stage I-II disease In inoperable stage IIIAB disease the recommended treatment is combined chemotherapy and radiation therapy Various kinds of combination of 2 modalities have been used either in sequential or concurrent setting Concurrent chemoradiotherapyCCRT have been recognized to have better survival than radiation therapy alone or sequential therapy but additional consolidation chemotherapy after CCRT is not yet to be determined for the beneficial role in survival gain Docetaxel is an anticancer drug and has synergistic anticancer effect in various cancer with cisplatin another anticancer drug In the present study randomised trial will be performed to confirm the efficacy of the consolidation chemotherapy with docetaxel and cisplatin after completing CCRT with the same chemotherapeutic agents in stage III inoperable NSCLC on progression free survival and overall survival
Detailed Description: None

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