Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer

NCT ID: NCT00639327

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-06-30

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

CPT-11+ S-1

Group Type: EXPERIMENTAL

S-1 + irinotecan

Intervention Type: DRUG

Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD

B

CPT-11

Group Type: ACTIVE_COMPARATOR

irinotecan

Intervention Type: DRUG

Irinotecan 150mg/m2 iv on day one every two weeks until PD

Interventions

S-1 + irinotecan

Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD

Intervention Type: DRUG

irinotecan

Irinotecan 150mg/m2 iv on day one every two weeks until PD

Intervention Type: DRUG

Other Intervention Names

TS-1; CPT-11; CPT-11

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Japan Clinical Cancer Research Organization

OTHER

Sponsor Role: lead

Responsible Party

Department of Digestive Surgery, Surugadai Nihon University Hospital

Principal Investigators

Masashi Fujii, M.D.,PhD

Role: PRINCIPAL_INVESTIGATOR

Surugadai Nihon University Hospital

Locations

Midori Municipal Hospital

Nagoya, Aichi-ken, Japan

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Aichi Medical University Hospital

Okazaki, Aichi-ken, Japan

Nakadoori General Hospital

Akita, Akita, Japan

Yamamoto Hospital

Noshiro, Akita, Japan

Aomori Prefectural Central Hospital

Aomori, Aomori, Japan

Hirosahi University Graduate School of Medicine

Hirosaki, Aomori, Japan

ChibaUniversity Hospital

Chiba, Chiba, Japan

Fukui Red Cross Hospital

Fukui-shi, Fukui, Japan

Saiseikai Hospital

Fukui-shi, Fukui, Japan

University of Fukui Faculty of Medical Scieneces Hospital

Yoshida-gun, Fukui, Japan

Saiseikai Fukuoka General Hospital

Fukuoka, Fukuoka, Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, Japan

National Kyusyu Cancer Center

Fukuoka, Fukuoka, Japan

Kyusyu University Faculty of Medical Sciences

Fukuoka, Fukuoka, Japan

Nippon Steel Yawata Memorial Hospital

Kitakyushu, Fukuoka, Japan

Kurume University Hospital

Kurume, Fukuoka, Japan

Fukushima Medical University

Fukushima, Fukushima, Japan

Gifu Municipal Hospital

Gifu, Gifu, Japan

Gifu Prefectural General Medical Center

Gifu, Gifu, Japan

Graduate School of Medicine, Gifu University

Gifu, Gifu, Japan

Gunma University Hospital

Maehashi, Gunma, Japan

Gunma Prefectural Cancer Center

Oota, Gunma, Japan

Fukuyama City Hospital

Fukuyama, Hiroshima, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery

Hiroshima, Hiroshima, Japan

Asahikawa Medical College Department Medicine

Asahikawa, Hokkaido, Japan

Asahikawa Medical College Hospital

Asahikawa, Hokkaido, Japan

Hakodate Goryoukaku Hopsital

Hakodate, Hokkaido, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Hyogo Prefectural Awaji Hospital

Sumoto, Hyōgo, Japan

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, Japan

Kanazawa Medical University Hospital

Nakajima, Ishikawa-ken, Japan

Iwate Prefectural Central Hospital

Morioka, Iwate, Japan

Iwate Medical University Hospital

Morioka, Iwate, Japan

Kagawa Medical University Hospital

Kida, Kagawa-ken, Japan

National Hospital Organization Kagoshima Medical Center

Kagoshima, Kagoshima-ken, Japan

Kirishima Medical Center

Kirishima, Kagoshima-ken, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

St.Marianna University School Of Medicine Hospital

Kawasaki, Kanagawa, Japan

Showa University Northern Yokohama Hospital

Yokohama, Kanagawa, Japan

Showa University Fujigaoka Hospital

Yokohama, Kanagawa, Japan

Citizen's General Medical Center attached to Yokohama City University

Yokohama, Kanagawa, Japan

Kochi Health Sciences Center

Kochi, Kochi, Japan

Kumamoto Medical University Hospital

Kumamoto, Kumamoto, Japan

Miyagi Cancer Center

Natori-shi, Miyagi, Japan

Institute of Development,Aging and Cancer,Tohoku University

Sendai, Miyagi, Japan

Tohoku University School Of Medicine

Sendai, Miyagi, Japan

Sendai Medical Center

Sendai, Miyagi, Japan

Nagano Municipal Hospital

Nagano, Nagano, Japan

Niigata Prefectural Cancer Center

Niigata, Niigata, Japan

Kaneda Hospital

Maniwa, Okayama-ken, Japan

National Hospital Organization Okayama Medical Center

Okayama, Okayama-ken, Japan

Rinku General Medical Center

Izumisano, Osaka, Japan

Kimen Municipal Hospital

Kimen, Osaka, Japan

Kitano Hospital

Osaka, Osaka, Japan

Osaka City University Graduate School of Medicine

Osaka, Osaka, Japan

Osaka Koseinenkin Hospital

Osaka, Osaka, Japan

Osaka General Medical Center

Osaka, Osaka, Japan

Sakai Municipal Hospital

Sakai, Osaka, Japan

Osaka Rosai Hospital

Sakai, Osaka, Japan

Suita Municipal Hospital Website

Suita, Osaka, Japan

Yao City Hospital

Yao, Osaka, Japan

Saga Prefectural Hospital Kouseikan

Saga, Saga-ken, Japan

Saiseikai Shiga Hospital

Rittō, Shiga, Japan

Shimane University Faculty of Medicine

Izumo, Shimane, Japan

Matsue City Hospital

Matsue, Shimane, Japan

Dokkyo University School of Medecine

Shimotsuga, Tochigi, Japan

Nippon Medical School

Bunkyo-ku, Tokyo, Japan

Surugadai Nihon University Hospital

Chiyoda-ku, Tokyo, Japan

Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, Japan

Toho University Ohhashi Medical Center

Meguro-ku, Tokyo, Japan

Toranomon Hospital

Minato-ku, Tokyo, Japan

The Jikei University

Minato-ku, Tokyo, Japan

International University of Health and Welfare Mita Hospital

Minato-ku, Tokyo, Japan

Toho University Omori Medical Center

Oota-ku, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Tokyo Women's Medical University Institute of Gastorenterology

Shinjuku-ku, Tokyo, Japan

Metropolitan Bokutoh Hospital

Sumida-ku, Tokyo, Japan

Tottori University Faculty of Medicine

Yonago, Tottori, Japan

Saiseikai Takaoka Hospital

Takaoka, Toyama, Japan

Kouseiren Takaoka Hospital

Takaoka, Toyama, Japan

Toyama Prefectural Center Hospital

Toyama, Toyama, Japan

Yamagata University Faculty Of Medicine

Yamagata, Yamagata, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 26109630 (View on PubMed)

Other Identifiers

JACCRO GC-05

Identifier Type: -

Identifier Source: org_study_id