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Sponsored by: |
Korean Cancer Study Group |
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Information provided by: | Korean Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00343668 |
The primary goal of this phase II trial is to evaluate the response rate of combination chemotherapy with S-1 and Irinotecan in patients with advanced gastric cancer as a first-line therapy.
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: S-1, irinotecan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of S-1 and Irinotecan Combination Chemotherapy in Patients With Advanced Gastric Cancer as a First-Line Therapy |
Estimated Enrollment: | 44 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | July 2008 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other serious illness or medical conditions
concomitant drug medication; The following drugs cause drug interaction with S-1.
i. Warfarin, phenprocoumon: increase bleeding tendency ii. Increase blood concentration of phenytoin iii. sorivudine: inhibit DPD -> increase toxicity according to fluoropyrimidine iv. allopurinol : decrease activity of S-1
Contact: Baek-Yeol Ryoo, M.D., Ph.D. | +82-2-970-1208 | ryooby@kcch.re.kr |
Contact: Hye Jin Kang, M.D. | +82-2-970-1289 | hyejin@kcch.re.kr |
Korea, Republic of | |
Seoul Veterans Hospital | Not yet recruiting |
Seoul, Korea, Republic of, 134-791 | |
Contact: Bong-Seog Kim, M.D., Ph.D. +82-2-2225-1319 seog@e-bohun.or.kr | |
Principal Investigator: Bong-Seog Kim, M.D., Ph.D. | |
Inha University hospital | Not yet recruiting |
Inchon, Korea, Republic of | |
Contact: Moon Hee Lee, M.D., Ph.D. +82-32-890-2583 moonhlmd@inha.ac.kr | |
Principal Investigator: Moon Hee Lee, M.D., Ph.D. | |
Yonsei Cancer Center | Recruiting |
Seoul, Korea, Republic of, 120-752 | |
Contact: Hyun Cheol Chung, M.D., Ph.D. +82-2-2228-8132 unchung8@yumc.yonsei.ac.kr | |
Principal Investigator: Hyun Cheol Chung, M.D., Ph.D. | |
Sub-Investigator: Sun Young Rha, M.D., Ph.D. | |
Sub-Investigator: Hei-Cheul Jeung, M.D., Ph.D. | |
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine | Not yet recruiting |
Seoul, Korea, Republic of, 110-746 | |
Contact: Seung Sei Lee, M.D., Ph.D. +82-2-2001-2084 llssss.lee@samsung.com | |
Principal Investigator: Seung Sei Lee, M.D., Ph.D. | |
Sub-Investigator: Suk Joong Oh, M.D., Ph.D. | |
Sub-Investigator: Kwon Choi, M.D. | |
Korea Institute of radiological and Medical Sciences | Recruiting |
Seoul, Korea, Republic of, 139-706 | |
Contact: Baek-Yeol Ryoo, M.D., Ph.D. +82-2-970-1208 ryooby@kcch.re.kr | |
Principal Investigator: Baek-Yeol Ryoo, M.D., Ph.D. | |
Sub-Investigator: Sung Hyun Yang, M.D., Ph.D. | |
Sub-Investigator: Hye Jin Kang, M.D. | |
Sub-Investigator: Im Il Nah, M.D. | |
Korea, Republic of, Jeolanam-do | |
Chonnam National University Hwasun Hospital | Recruiting |
Hwasun-gun, Jeolanam-do, Korea, Republic of, 519-809 | |
Contact: Sang Hee Cho, M.D., Ph.D. +82-61-379-7633 sh115@chollian.net | |
Sub-Investigator: Sang Hee Cho, M.D., Ph.D. | |
Korea, Republic of, Jeonbuk | |
Chonbuk National University Hospital | Not yet recruiting |
Jeonju, Jeonbuk, Korea, Republic of, 561-712 | |
Contact: Eun Kee Song, M.D. +82-63-250-1245 eksong@chonbuk.ac.kr | |
Principal Investigator: Eun Kee Song, M.D. |
Principal Investigator: | Baek-Yeol Ryoo, M.D., Ph.D. | Korea Institute of Radiological and Medical Sciences |
Responsible Party: | Korea Cancer Center Hospital ( Baek-Yeol Ryoo ) |
Study ID Numbers: | KCSG-ST05-02 |
Study First Received: | June 22, 2006 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00343668 History of Changes |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
advanced gastric cancer First-line therapy S-1 irinotecan |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Stomach Neoplasms |
Irinotecan Gastrointestinal Neoplasms Stomach Cancer Antineoplastic Agents, Phytogenic |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Irinotecan Enzyme Inhibitors Pharmacologic Actions Neoplasms |
Neoplasms by Site Digestive System Diseases Stomach Diseases Stomach Neoplasms Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |