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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Labour and Welfare, Japan
Taiho Pharmaceutical Co., Ltd.
Yakult Honsha Co., LTD
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00142350
First received: September 1, 2005
Last updated: May 31, 2007
Last verified: May 2007
  Purpose

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


Condition Intervention Phase
Gastric Cancer
Drug: continuous infusion of 5-fluorouracil
Drug: combination of irinotecan and cisplatin
Drug: oral administration of S-1
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • overall survival

Secondary Outcome Measures:
  • time to treatment failure
  • incidences of adverse events
  • response rate
  • non-hospitalized survival

Estimated Enrollment: 690
Study Start Date: November 2000
Estimated Study Completion Date: January 2007
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).

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142350

Locations
Japan
Aichi Cancer Center Hospital
1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681
Aichi Cancer Center,Aichi Hospital
18,Kuriyado,Kake-machi,Okazaki, Aichi, Japan, 444-0011
Nagoya Medical Center
4-1-1,Sannomaru,Naka-ku,Nagoya, Aichi, Japan, 460-0001
Aomori Prefectural Central Hospital
2-1-1,Higashitsukurimiti,Aomori, Aomori, Japan, 030-0911
National Cancer Center Hospital East
6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577
Chiba Cancer Center Hospital
666-2,Nitona-cho,Chuo-ku,Chiba, Chiba, Japan, 260-8717
Asahi General Hospital
I-1326,Asahi, Chiba, Japan, 289-2511
National Hospital Organization Shikoku Cancer Center
13,Horinouchi,Matsuyama, Ehime, Japan, 790-0007
Kyushu University Hospital
3-1-1,Maidashi,Higashi-ku,Fukuoka, Fukuoka, Japan, 812-8582
National Kyushu Cancer Center
3-1-1,Notame,Minami-ku,Fukuoka, Fukuoka, Japan, 811-1395
Federation of national public service personnel mutual aid associations Tonan Hospital
kita 1 nishi 6,Chuo-ku,Sapporo, Hokkaido, Japan, 060-0001
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648
Hyogo Medical Center for Adults
13-70,Kitaouji-cho,Akashi, Hyogo, Japan, 673-8558
Kobe University Graduate School of Medicine
7-5-2,Kusunoki-cho,Chuo-ku,Kobe, Hyogo, Japan, 650-0017
Ibaraki Kenritsu Chuo Hospital & Cancer Center
6528 Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki, Japan, 309-1793
Iwate Prefectural Central Hospital
1-4-1,Ueda,Morioka, Iwate, Japan, 020-0066
Kanagawa Cancer Center
1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0815
Kitasato University East Hospital
2-1-1,Asamizodai,Sagamihara, Kanagawa, Japan, 228-8520
Yokohama City University Medical Center
4-57,Urafunecho,Minami-ku,Yokohama, Kanagawa, Japan, 232-0024
Yokohama Mucipical Citizen's Hospital
56,Okazawa-cho,Hodogaya-ku,Yokohama, Kanagawa, Japan, 240-8555
Kochi Health Science Center
2125-1,Ike,Kochi, Kochi, Japan, 781-8555
Kumamoto Regional Medical Center Hospital
5-16-10,Honjo,Kumamoto, Kumamoto, Japan, 860-0811
Kyoto University Hospital
54,Syogoinkawara,Sakyo-ku,Kyoto, Kyoto, Japan, 606-8507
Tohoku University Hospital
1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi, Japan, 980-8574
Saku Central Hospital
197,Usuda,Saku, Nagano, Japan, 384-0301
Osaka Medical College
2-7,Daigakucho,Takatsuki, Osaka, Japan, 569-0801
Saitama Medical School Hospital
38,Morohongo,Moroyama-machi,Iruma-gun, Saitama, Japan, 350-0495
Saitama Cancer Center
818,Komuro,Ina,Kita-adachi, Saitama, Japan, 362-0806
Div. of Gastrointestinal Oncology, Shizuoka Cancer Center
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan, 411-8777
Tochigi Cancer Center
4-9-13,Yohnan,Utsunomiya, Tochigi, Japan, 320-0834
Showa University School of Medicine
1-5-8,Hatanodai,Shinagawa-ku, Tokyo, Japan, 142-8666
Cancer Institute Hospital
3-10-6,Ariake,Koto-ku, Tokyo, Japan, 135-8550
National Cancer Center Hospital
5-1-1,Tsukiji,Chuo-ku, Tokyo, Japan, 104-0045
Yamagata Prefectural Central Hospital
1800,Aoyagi,Yamagata, Yamagata, Japan, 990-2292
Sponsors and Collaborators
Japan Clinical Oncology Group
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
  More Information

Additional Information:
No publications provided by Japan Clinical Oncology Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00142350     History of Changes
Other Study ID Numbers: JCOG9912, C000000062
Study First Received: September 1, 2005
Last Updated: May 31, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
gastric cancer
5-fluorouracil
irinotecan
cisplatin
S-1
advanced or recurrent gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014