A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer

• ClinicalTrials.gov Identifier: NCT00142350
• Recruitment Status: Completed
• First Posted: September 2, 2005
• Last Update Posted: September 12, 2016
• Sponsor: Japan Clinical Oncology Group
• Collaborators: Ministry of Health, Labour and Welfare, Japan; Taiho Pharmaceutical Co., Ltd.; Yakult Honsha Co., LTD
• Information provided by: Japan Clinical Oncology Group

Tracking Information

• First Submitted Date: September 1, 2005
• First Posted Date: September 2, 2005
• Last Update Posted Date: September 12, 2016
• Study Start Date: November 2000
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 1, 2005): overall survival
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 1, 2005)

• time to treatment failure
• incidences of adverse events
• response rate
• non-hospitalized survival

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer
• Official Title: Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)
• Brief Summary: To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer
• Detailed Description: From the results of our previous phase III study (JCOG9205), continuous infusion of 5-fluorouracil has remained to be a control arm of this study. This study investigates the superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall survival, and the planned number of enrolled patients is 690 (230/arm).
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Cancer

Intervention

• Drug: continuous infusion of 5-fluorouracil
• Drug: combination of irinotecan and cisplatin
• Drug: oral administration of S-1

• Study Arms: Not Provided

Publications *

• Kurokawa Y, Boku N, Yamaguchi T, Ohtsu A, Mizusawa J, Nakamura K, Fukuda H. Inter-institutional heterogeneity in outcomes of chemotherapy for metastatic gastric cancer: correlative study in the JCOG9912 phase III trial. ESMO Open. 2016 Feb 8;1(1):e000031. doi: 10.1136/esmoopen-2015-000031. eCollection 2016.
• Takahari D, Boku N, Mizusawa J, Takashima A, Yamada Y, Yoshino T, Yamazaki K, Koizumi W, Fukase K, Yamaguchi K, Goto M, Nishina T, Tamura T, Tsuji A, Ohtsu A. Determination of prognostic factors in Japanese patients with advanced gastric cancer using the data from a randomized controlled trial, Japan clinical oncology group 9912. Oncologist. 2014 Apr;19(4):358-66. doi: 10.1634/theoncologist.2013-0306. Epub 2014 Mar 25.
• Boku N, Yamamoto S, Fukuda H, Shirao K, Doi T, Sawaki A, Koizumi W, Saito H, Yamaguchi K, Takiuchi H, Nasu J, Ohtsu A; Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group. Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol. 2009 Nov;10(11):1063-9. doi: 10.1016/S1470-2045(09)70259-1. Epub 2009 Oct 7.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 1, 2005): 690
• Original Enrollment: Same as current
• Study Completion Date: January 2007
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

1. unresectable or recurrent histologically proved gastric cancer
2. adequate oral intake
3. age 20 or older and 75 or younger
4. Performance Status (ECOG):0, 1, 2
5. measurable or unmeasurable lesions
6. preserved organ functions
7. no severe medical condition
8. no prior chemotherapy for gastric cancer
9. written informed consent

Exclusion Criteria:

1. patient with marked infection or inflammation
2. patient with severe peritoneal metastasis
3. patient with massive pleural effusion
4. patient with metastasis to CNS
5. patient with diarrhea 4 or more times per day
6. patient severe medical condition
7. patient with other concurrent malignancy affecting on survival or adverse events
8. pregnant or nursing patient or with intent to bear baby
9. patient evaluated to be inadequate by a attending doctor
10. patient requiring nutritional support

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00142350
• Other Study ID Numbers: JCOG9912; C000000062
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Japan Clinical Oncology Group
• Original Study Sponsor: Same as current

Collaborators

• Ministry of Health, Labour and Welfare, Japan
• Taiho Pharmaceutical Co., Ltd.
• Yakult Honsha Co., LTD

Investigators

• Study Chair: Atsushi Ohtsu, MD; National Cancer Centr Hospital East

• PRS Account: Japan Clinical Oncology Group
• Verification Date: September 2016