Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer
- Registration Number
- NCT00639327
- Lead Sponsor
- Japan Clinical Cancer Research Organization
- Brief Summary
The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer.
- Detailed Description
Standard chemotherapy for advanced gastric cancer (AGC) in the US is Cisplatin/5-FU (CF) or docetaxel/CF (DCF), is in Europe epirubicin/CF (ECF) or epirubicin/oxaliplatin/ capecitabine (EOX). Until 2006, there was no evidence of standard chemotherapy for AGC in Japan. In 2007, by the results of JCOG9912 trial (5-FU alone vs. CPT-11/CDDP vs S-1) and SPIRITS trial (S-1 alone vs. S-1/CDDP), S-1/CDDP is regarded as a new standard regimen in Japan. In 2008, by the results of TOP-002 trial (s-1 alone vs. S-1/CPT-11), S-1/CPT-11 could not show the superiority to S-1 alone. One of the other phase III trials, JACCRO GC-03 trial (S-1 alone vs. S-1/docetaxel, NCT00287768) is now ongoing. However, the position of CPT-11 in the treatment of AGC will be regarded as a second-line.
In Japan there is a controversy for the treatment of S-1 refractory gastric cancer. The controversy is continuing S-1 (like FOLFOX to FOLFIRI) or not as a second-line. After the successful adjuvant S-1 results (ACTS-GC trial), the same problem will occur in the patients who are recurrent from adjuvant S-1.
Then, we conducted a phase II/III trial of CPT-11 with or without S-1 in the treatment of first-line S-1 refractory AGC.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma
- Subjects must be able to take orally
- Subjects must be confirmed to be PD status by picture diagnosis after first-line chemotherapy using S-1 alone, S-1 + Cisplatinum or S-1 + taxane, except S-1 + CPT-11
- Within 4 weeks from the diagnosis of PD
- Total dosage of S-1 at the first-line is over 2,240mg/m2 in S-1 alone treatment, 1,680mg/m2 in the S-1 combination
- ECOG performance status ≤ 1
- Follow up Age 20 or over
- Life expectancy estimated more than 12 weeks
- Hgb ≥ 8 g/dL, WBC 4,000-12,000/mm3, ANC ≥ 2,000/mm3, platelets ≥ 100,000/mm3
- Creatinine ≤ upper normal limit (UNL)
- Total bilirubin ≤ 1.5 X UNL
- Written informed consent
- S-1 + CPT-11 was employed as a first-line
- Any other cytotoxic agents therapy, immuno-therapy, radiation-therapy
- After S-1 adjuvant
- Suspended cases by adverse events by S-1 or S-1 combination
- Excessive amounts of ascites require drainage
- Known brain metastases
- History of hypersensitivity to fluoropyrimidines and CPT-11
- Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
- Active double cancer
- Gastrointestinal bleeding
- Any subject judged by the investigator to be unfit for any reason to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A S-1 + irinotecan CPT-11+ S-1 B irinotecan CPT-11
- Primary Outcome Measures
Name Time Method In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet. Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization
- Secondary Outcome Measures
Name Time Method Adverse events, response rates, progression free survival, time to treatment failure, change over rates to 3rd line 2 years
Related Research Topics
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Trial Locations
- Locations (86)
Hirosahi University Graduate School of Medicine
🇯🇵Hirosaki, Aomori, Japan
Fukuyama City Hospital
🇯🇵Fukuyama, Hiroshima, Japan
Asahikawa Medical College Hospital
🇯🇵Asahikawa, Hokkaido, Japan
University of Fukui Faculty of Medical Scieneces Hospital
🇯🇵Yoshida-gun, Fukui, Japan
Hakodate Goryoukaku Hopsital
🇯🇵Hakodate, Hokkaido, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Sakai Municipal Hospital
🇯🇵Sakai, Osaka, Japan
Midori Municipal Hospital
🇯🇵Nagoya, Aichi, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Kanazawa Medical University Hospital
🇯🇵Kawakita, Ishikawa, Japan
Kirishima Medical Center
🇯🇵Kirishima, Kagoshima, Japan
Gunma University Hospital
🇯🇵Maehashi, Gunma, Japan
Gunma Prefectural Cancer Center
🇯🇵Oota, Gunma, Japan
Sendai Medical Center
🇯🇵Sendai, Miyagi, Japan
Asahikawa Medical College Department Medicine
🇯🇵Asahikawa, Hokkaido, Japan
Hyogo Prefectural Awaji Hospital
🇯🇵Sumoto, Hyogo, Japan
Tokai University Hospital
🇯🇵Isehara, Kanagawa, Japan
Yao City Hospital
🇯🇵Yao, Osaka, Japan
Saiseikai Shiga Hospital
🇯🇵Ritto, Shiga, Japan
Surugadai Nihon University Hospital
🇯🇵Chiyoda-ku, Tokyo, Japan
Showa University Northern Yokohama Hospital
🇯🇵Yokohama, Kanagawa, Japan
Showa University Fujigaoka Hospital
🇯🇵Yokohama, Kanagawa, Japan
Kimen Municipal Hospital
🇯🇵Kimen, Osaka, Japan
Citizen's General Medical Center attached to Yokohama City University
🇯🇵Yokohama, Kanagawa, Japan
Miyagi Cancer Center
🇯🇵Natori, Miyagi, Japan
Osaka Rosai Hospital
🇯🇵Sakai, Osaka, Japan
Suita Municipal Hospital Website
🇯🇵Suita, Osaka, Japan
Matsue City Hospital
🇯🇵Matsue, Shimane, Japan
Dokkyo University School of Medecine
🇯🇵Shimotsuga, Tochigi, Japan
Saiseikai Fukuoka General Hospital
🇯🇵Fukuoka, Japan
Kyusyu University Faculty of Medical Sciences
🇯🇵Fukuoka, Japan
Toranomon Hospital
🇯🇵Minato-ku, Tokyo, Japan
Nihon University Itabashi Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
Tokyo Women's Medical University Institute of Gastorenterology
🇯🇵Shinjuku-ku, Tokyo, Japan
Rinku General Medical Center
🇯🇵Izumisano, Osaka, Japan
Tottori University Faculty of Medicine
🇯🇵Yonago, Tottori, Japan
Kouseiren Takaoka Hospital
🇯🇵Takaoka, Toyama, Japan
National Kyusyu Cancer Center
🇯🇵Fukuoka, Japan
Fukushima Medical University
🇯🇵Fukushima, Japan
Yamagata University Faculty Of Medicine
🇯🇵Yamagata, Japan
Teikyo University Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
Saga Prefectural Hospital Kouseikan
🇯🇵Saga, Japan
National Hospital Organization Kagoshima Medical Center
🇯🇵Kagoshima, Japan
Osaka Koseinenkin Hospital
🇯🇵Osaka, Japan
Toho University Ohhashi Medical Center
🇯🇵Meguro-ku, Tokyo, Japan
Aomori Prefectural Central Hospital
🇯🇵Aomori, Japan
Fukui Red Cross Hospital
🇯🇵Fukui, Japan
National Hospital Organization Okayama Medical Center
🇯🇵Okayama, Japan
Kochi Health Sciences Center
🇯🇵Kochi, Japan
Kitano Hospital
🇯🇵Osaka, Japan
Gifu Prefectural General Medical Center
🇯🇵Gifu, Japan
Kumamoto Medical University Hospital
🇯🇵Kumamoto, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan
Yamamoto Hospital
🇯🇵Noshiro, Akita, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Toyama Prefectural Center Hospital
🇯🇵Toyama, Japan
Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery
🇯🇵Hiroshima, Japan
Nagano Municipal Hospital
🇯🇵Nagano, Japan
Niigata Prefectural Cancer Center
🇯🇵Niigata, Japan
Shimane University Faculty of Medicine
🇯🇵Izumo, Shimane, Japan
Gifu Municipal Hospital
🇯🇵Gifu, Japan
Osaka City University Graduate School of Medicine
🇯🇵Osaka, Japan
Nippon Medical School
🇯🇵Bunkyo-ku, Tokyo, Japan
Nakadoori General Hospital
🇯🇵Akita, Japan
Toho University Omori Medical Center
🇯🇵Oota-ku, Tokyo, Japan
ChibaUniversity Hospital
🇯🇵Chiba, Japan
Aichi Medical University Hospital
🇯🇵Aichi, Japan
Graduate School of Medicine, Gifu University
🇯🇵Gifu, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Saiseikai Hospital
🇯🇵Fukui, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Nippon Steel Yawata Memorial Hospital
🇯🇵Kitakyusyu, Fukuoka, Japan
Iwate Prefectural Central Hospital
🇯🇵Morioka, Iwate, Japan
Kagawa Medical University Hospital
🇯🇵Kida, Kagawa, Japan
Iwate Medical University Hospital
🇯🇵Morioka, Iwate, Japan
St.Marianna University School Of Medicine Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Kaneda Hospital
🇯🇵Maniwa, Okayama, Japan
Institute of Development,Aging and Cancer,Tohoku University
🇯🇵Sendai, Miyagi, Japan
Tohoku University School Of Medicine
🇯🇵Sendai, Miyagi, Japan
The Jikei University
🇯🇵Minato-ku, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
International University of Health and Welfare Mita Hospital
🇯🇵Minato-ku, Tokyo, Japan
Metropolitan Bokutoh Hospital
🇯🇵Sumida-ku, Tokyo, Japan
Saiseikai Takaoka Hospital
🇯🇵Takaoka, Toyama, Japan