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

Gastric Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142350
• Other study ID #: JCOG9912
• Secondary ID: C000000062
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: September 8, 2016
• Start date: November 2000
• Est. completion date: January 2007

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 690
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• continuous infusion of 5-fluorouracil

• combination of irinotecan and cisplatin

• oral administration of S-1

Locations

Country	Name	City	State
Japan	Hyogo Medical Center for Adults	Akashi,Kitaouji-cho,13-70	Hyogo
Japan	Chiba Cancer Center Hospital	Chiba,Chuo-ku,Nitona-cho,666-2	Chiba
Japan	National Cancer Center Hospital	Chuo-ku,Tsukiji,5-1-1	Tokyo
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	Aomori Prefectural Central Hospital	Higashitsukurimiti,2-1-1,Aomori	Aomori
Japan	Asahi General Hospital	I-1326,Asahi	Chiba
Japan	Saitama Medical School Hospital	Iruma-gun,Moroyama-machi,Morohongo,38	Saitama
Japan	National Cancer Center Hospital East	Kashiwa,Kashiwanoha,6-5-1	Chiba
Japan	Federation of national public service personnel mutual aid associations Tonan Hospital	kita 1 nishi 6,Chuo-ku,Sapporo	Hokkaido
Japan	Saitama Cancer Center	Kita-adachi,Ina,Komuro,818	Saitama
Japan	Kobe University Graduate School of Medicine	Kobe,Chuo-ku,Kusunoki-cho,7-5-2	Hyogo
Japan	Kochi Health Science Center	Kochi,Ike,2125-1	Kochi
Japan	Cancer Institute Hospital	Koto-ku,Ariake,3-10-6	Tokyo
Japan	Kumamoto Regional Medical Center Hospital	Kumamoto,Honjo,5-16-10	Kumamoto
Japan	Kyoto University Hospital	Kyoto,Sakyo-ku,Syogoinkawara,54	Kyoto
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama,Horinouchi,13	Ehime
Japan	Iwate Prefectural Central Hospital	Morioka,Ueda,1-4-1	Iwate
Japan	Aichi Cancer Center Hospital	Nagoya,Chikusa-ku,Kanokoden,1-1	Aichi
Japan	Nagoya Medical Center	Nagoya,Naka-ku,Sannomaru,4-1-1	Aichi
Japan	Ibaraki Kenritsu Chuo Hospital & Cancer Center	Nishi-ibarakigun,Tomobemachi,Koibuchi,6528	Ibaraki
Japan	Hokkaido University Hospital	North-14 West-5 Kita-ku,Sapporo	Hokkaido
Japan	Aichi Cancer Center,Aichi Hospital	Okazaki,Kake-machi,Kuriyado,18	Aichi
Japan	Kitasato University East Hospital	Sagamihara,Asamizodai,2-1-1	Kanagawa
Japan	Saku Central Hospital	Saku,Usuda,197	Nagano
Japan	Tohoku University Hospital	Sendai,Aoba-ku,Seiryo-machi,1-1	Miyagi
Japan	Showa University School of Medicine	Shinagawa-ku,Hatanodai,1-5-8	Tokyo
Japan	Div. of Gastrointestinal Oncology, Shizuoka Cancer Center	Sunto-gun, Nagaizumi-cho, Shimonagakubo,1007	Shizuoka
Japan	Osaka Medical College	Takatsuki,Daigakucho,2-7	Osaka
Japan	Tochigi Cancer Center	Utsunomiya,Yohnan,4-9-13	Tochigi
Japan	Yamagata Prefectural Central Hospital	Yamagata,Aoyagi,1800	Yamagata
Japan	Kanagawa Cancer Center	Yokohama,Asahi-ku,Nakao,1-1-2	Kanagawa
Japan	Yokohama Mucipical Citizen's Hospital	Yokohama,Hodogaya-ku,Okazawa-cho,56	Kanagawa
Japan	Yokohama City University Medical Center	Yokohama,Minami-ku,Urafunecho,4-57	Kanagawa

Sponsors (4)

Lead Sponsor	Collaborator
Japan Clinical Oncology Group	Ministry of Health, Labour and Welfare, Japan, Taiho Pharmaceutical Co., Ltd., Yakult Honsha Co., LTD

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival
Secondary	time to treatment failure
Secondary	incidences of adverse events
Secondary	response rate
Secondary	non-hospitalized survival

External Links

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