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

Phase 3

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT00142350
• Lead Sponsor: Japan Clinical Oncology Group

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 Timeline

• Study Start: 2000-11
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Study Completion: 2007-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 690

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
overall survival

Secondary Outcome Measures

Name	Time	Method
incidences of adverse events
time to treatment failure
response rate
non-hospitalized survival

Trial Locations

Locations (34)

Aichi Cancer Center Hospital; 🇯🇵 Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan

Nagoya Medical Center; 🇯🇵 Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi, Japan

Aichi Cancer Center,Aichi Hospital; 🇯🇵 Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan

Aomori Prefectural Central Hospital; 🇯🇵 Higashitsukurimiti,2-1-1,Aomori, Aomori, Japan

Chiba Cancer Center Hospital; 🇯🇵 Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan

Asahi General Hospital; 🇯🇵 I-1326,Asahi, Chiba, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

National Hospital Organization Shikoku Cancer Center; 🇯🇵 Matsuyama,Horinouchi,13, Ehime, Japan

Kyushu University Hospital; 🇯🇵 Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan

National Kyushu Cancer Center; 🇯🇵 Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan

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