Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer
Randomized Phase II/III Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer
1 other identifier
interventional
300
1 country
86
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Mar 2008
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 5, 2008
CompletedFirst Posted
Study publicly available on registry
March 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 28, 2011
June 1, 2011
3.1 years
March 5, 2008
June 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Adverse events, response rates, progression free survival, time to treatment failure, change over rates to 3rd line
2 years
Study Arms (2)
A
EXPERIMENTALCPT-11+ S-1
B
ACTIVE COMPARATORCPT-11
Interventions
Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
Midori Municipal Hospital
Nagoya, Aichi-ken, 458-0037, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Aichi Medical University Hospital
Okazaki, Aichi-ken, 480-1195, Japan
Nakadoori General Hospital
Akita, Akita, 010-8577, Japan
Yamamoto Hospital
Noshiro, Akita, 016-0014, Japan
Aomori Prefectural Central Hospital
Aomori, Aomori, 030-8553, Japan
Hirosahi University Graduate School of Medicine
Hirosaki, Aomori, 036-8562, Japan
ChibaUniversity Hospital
Chiba, Chiba, 260-8677, Japan
Fukui Red Cross Hospital
Fukui-shi, Fukui, 918-8501, Japan
Saiseikai Hospital
Fukui-shi, Fukui, 918-8503, Japan
University of Fukui Faculty of Medical Scieneces Hospital
Yoshida-gun, Fukui, 910-1193, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, Fukuoka, 810-0001, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563, Japan
National Kyusyu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Kyusyu University Faculty of Medical Sciences
Fukuoka, Fukuoka, 812-8582, Japan
Nippon Steel Yawata Memorial Hospital
Kitakyushu, Fukuoka, 805-8508, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
Fukushima Medical University
Fukushima, Fukushima, 960-1295, Japan
Gifu Municipal Hospital
Gifu, Gifu, 500-8513, Japan
Gifu Prefectural General Medical Center
Gifu, Gifu, 500-8717, Japan
Graduate School of Medicine, Gifu University
Gifu, Gifu, 501-1193, Japan
Gunma University Hospital
Maehashi, Gunma, 371-0034, Japan
Gunma Prefectural Cancer Center
Oota, Gunma, 373-8550, Japan
Fukuyama City Hospital
Fukuyama, Hiroshima, 721-8511, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery
Hiroshima, Hiroshima, 734-8553, Japan
Asahikawa Medical College Department Medicine
Asahikawa, Hokkaido, 078-8510, Japan
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, 078-8510, Japan
Hakodate Goryoukaku Hopsital
Hakodate, Hokkaido, 040-0001, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543, Japan
Hyogo Prefectural Awaji Hospital
Sumoto, Hyōgo, 656-0017, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530, Japan
Kanazawa Medical University Hospital
Nakajima, Ishikawa-ken, 920-0293, Japan
Iwate Prefectural Central Hospital
Morioka, Iwate, 020-0066, Japan
Iwate Medical University Hospital
Morioka, Iwate, 020-8505, Japan
Kagawa Medical University Hospital
Kida, Kagawa-ken, 761-0793, Japan
National Hospital Organization Kagoshima Medical Center
Kagoshima, Kagoshima-ken, 892-0853, Japan
Kirishima Medical Center
Kirishima, Kagoshima-ken, 899-5112, Japan
Tokai University Hospital
Isehara, Kanagawa, 259-1193, Japan
St.Marianna University School Of Medicine Hospital
Kawasaki, Kanagawa, 216-8511, Japan
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, 224-8503, Japan
Showa University Fujigaoka Hospital
Yokohama, Kanagawa, 227-8501, Japan
Citizen's General Medical Center attached to Yokohama City University
Yokohama, Kanagawa, 232-0024, Japan
Kochi Health Sciences Center
Kochi, Kochi, 781-8555, Japan
Kumamoto Medical University Hospital
Kumamoto, Kumamoto, 860-8556, Japan
Miyagi Cancer Center
Natori-shi, Miyagi, 981-1293, Japan
Institute of Development,Aging and Cancer,Tohoku University
Sendai, Miyagi, 980-8574, Japan
Tohoku University School Of Medicine
Sendai, Miyagi, 980-8574, Japan
Sendai Medical Center
Sendai, Miyagi, 983-8520, Japan
Nagano Municipal Hospital
Nagano, Nagano, 381-0006, Japan
Niigata Prefectural Cancer Center
Niigata, Niigata, 951-8566, Japan
Kaneda Hospital
Maniwa, Okayama-ken, 719-3105, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, 701-1192, Japan
Rinku General Medical Center
Izumisano, Osaka, 598-0048, Japan
Kimen Municipal Hospital
Kimen, Osaka, 562-8562, Japan
Kitano Hospital
Osaka, Osaka, 530-8480, Japan
Osaka City University Graduate School of Medicine
Osaka, Osaka, 545-8585, Japan
Osaka Koseinenkin Hospital
Osaka, Osaka, 553-0003, Japan
Osaka General Medical Center
Osaka, Osaka, 558-8558, Japan
Sakai Municipal Hospital
Sakai, Osaka, 590-0064, Japan
Osaka Rosai Hospital
Sakai, Osaka, 591-8025, Japan
Suita Municipal Hospital Website
Suita, Osaka, 564-0082, Japan
Yao City Hospital
Yao, Osaka, 581-0069, Japan
Saga Prefectural Hospital Kouseikan
Saga, Saga-ken, 840-8571, Japan
Saiseikai Shiga Hospital
Rittō, Shiga, 520-3046, Japan
Shimane University Faculty of Medicine
Izumo, Shimane, 693-8501, Japan
Matsue City Hospital
Matsue, Shimane, 690-8509, Japan
Dokkyo University School of Medecine
Shimotsuga, Tochigi, 321-0293, Japan
Nippon Medical School
Bunkyo-ku, Tokyo, 113-8603, Japan
Surugadai Nihon University Hospital
Chiyoda-ku, Tokyo, 101-8309, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, 173-8606, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 173-8610, Japan
Toho University Ohhashi Medical Center
Meguro-ku, Tokyo, 153-8515, Japan
Toranomon Hospital
Minato-ku, Tokyo, 105-8470, Japan
The Jikei University
Minato-ku, Tokyo, 105-8471, Japan
International University of Health and Welfare Mita Hospital
Minato-ku, Tokyo, 108-8329, Japan
Toho University Omori Medical Center
Oota-ku, Tokyo, 143-8541, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Tokyo Women's Medical University Institute of Gastorenterology
Shinjuku-ku, Tokyo, 162-8666, Japan
Metropolitan Bokutoh Hospital
Sumida-ku, Tokyo, 130-8575, Japan
Tottori University Faculty of Medicine
Yonago, Tottori, 683-8504, Japan
Saiseikai Takaoka Hospital
Takaoka, Toyama, 933-8525, Japan
Kouseiren Takaoka Hospital
Takaoka, Toyama, 933-8555, Japan
Toyama Prefectural Center Hospital
Toyama, Toyama, 930-8550, Japan
Yamagata University Faculty Of Medicine
Yamagata, Yamagata, 990-9585, Japan
Related Publications (1)
Tanabe K, Fujii M, Nishikawa K, Kunisaki C, Tsuji A, Matsuhashi N, Takagane A, Ohno T, Kawase T, Kochi M, Yoshida K, Kakeji Y, Ichikawa W, Chin K, Terashima M, Takeuchi M, Nakajima T. Phase II/III study of second-line chemotherapy comparing irinotecan-alone with S-1 plus irinotecan in advanced gastric cancer refractory to first-line treatment with S-1 (JACCRO GC-05). Ann Oncol. 2015 Sep;26(9):1916-1922. doi: 10.1093/annonc/mdv265. Epub 2015 Jun 24.
PMID: 26109630DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Masashi Fujii, M.D.,PhD
Surugadai Nihon University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 5, 2008
First Posted
March 20, 2008
Study Start
March 1, 2008
Primary Completion
April 1, 2011
Study Completion
June 1, 2011
Last Updated
June 28, 2011
Record last verified: 2011-06