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Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
S-1 + irinotecan
irinotecan
Sponsored by
Japan Clinical Cancer Research Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Stomach Neoplasms, Second line chemotherapy, Refractory to S-1, irinotecan, S-1 and Irinotecan Combination, Phase III study

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Midori Municipal Hospital
  • Nagoya City University Hospital
  • Yamamoto Hospital
  • Hirosahi University Graduate School of Medicine
  • University of Fukui Faculty of Medical Scieneces Hospital
  • Nippon Steel Yawata Memorial Hospital
  • Kurume University Hospital
  • Gunma University Hospital
  • Gunma Prefectural Cancer Center
  • Fukuyama City Hospital
  • Asahikawa Medical College Department Medicine
  • Asahikawa Medical College Hospital
  • Hakodate Goryoukaku Hopsital
  • National Hospital Organization Hokkaido Cancer Center
  • Sapporo Medical University Hospital
  • Hyogo Prefectural Awaji Hospital
  • Ishikawa Prefectural Central Hospital
  • Kanazawa Medical University Hospital
  • Iwate Prefectural Central Hospital
  • Iwate Medical University Hospital
  • Kagawa Medical University Hospital
  • Kirishima Medical Center
  • Tokai University Hospital
  • St.Marianna University School Of Medicine Hospital
  • Showa University Northern Yokohama Hospital
  • Showa University Fujigaoka Hospital
  • Citizen's General Medical Center attached to Yokohama City University
  • Miyagi Cancer Center
  • Institute of Development,Aging and Cancer,Tohoku University
  • Tohoku University School Of Medicine
  • Sendai Medical Center
  • Kaneda Hospital
  • Rinku General Medical Center
  • Kimen Municipal Hospital
  • Sakai Municipal Hospital
  • Osaka Rosai Hospital
  • Suita Municipal Hospital Website
  • Yao City Hospital
  • Saiseikai Shiga Hospital
  • Shimane University Faculty of Medicine
  • Matsue City Hospital
  • Dokkyo University School of Medecine
  • Nippon Medical School
  • Surugadai Nihon University Hospital
  • Teikyo University Hospital
  • Nihon University Itabashi Hospital
  • Toho University Ohhashi Medical Center
  • Toranomon Hospital
  • The Jikei University
  • International University of Health and Welfare Mita Hospital
  • Toho University Omori Medical Center
  • Keio University Hospital
  • Tokyo Women's Medical University Institute of Gastorenterology
  • Metropolitan Bokutoh Hospital
  • Tottori University Faculty of Medicine
  • Saiseikai Takaoka Hospital
  • Kouseiren Takaoka Hospital
  • Aichi Medical University Hospital
  • Nakadoori General Hospital
  • Aomori Prefectural Central Hospital
  • ChibaUniversity Hospital
  • Fukui Red Cross Hospital
  • Saiseikai Hospital
  • Saiseikai Fukuoka General Hospital
  • National Hospital Organization Kyushu Medical Center
  • National Kyusyu Cancer Center
  • Kyusyu University Faculty of Medical Sciences
  • Fukushima Medical University
  • Gifu Municipal Hospital
  • Gifu Prefectural General Medical Center
  • Graduate School of Medicine, Gifu University
  • Hiroshima University Hospital
  • Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery
  • National Hospital Organization Kagoshima Medical Center
  • Kochi Health Sciences Center
  • Kumamoto Medical University Hospital
  • Nagano Municipal Hospital
  • Niigata Prefectural Cancer Center
  • National Hospital Organization Okayama Medical Center
  • Kitano Hospital
  • Osaka City University Graduate School of Medicine
  • Osaka Koseinenkin Hospital
  • Osaka General Medical Center
  • Saga Prefectural Hospital Kouseikan
  • Toyama Prefectural Center Hospital
  • Yamagata University Faculty Of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

CPT-11+ S-1

CPT-11

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse events, response rates, progression free survival, time to treatment failure, change over rates to 3rd line

Full Information

First Posted
March 5, 2008
Last Updated
June 27, 2011
Sponsor
Japan Clinical Cancer Research Organization
Collaborators
Taiho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00639327
Brief Title
Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Clinical Cancer Research Organization
Collaborators
Taiho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Stomach Neoplasms, Second line chemotherapy, Refractory to S-1, irinotecan, S-1 and Irinotecan Combination, Phase III study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
CPT-11+ S-1
Arm Title
B
Arm Type
Active Comparator
Arm Description
CPT-11
Intervention Type
Drug
Intervention Name(s)
S-1 + irinotecan
Other Intervention Name(s)
TS-1, CPT-11
Intervention Description
Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD
Intervention Type
Drug
Intervention Name(s)
irinotecan
Other Intervention Name(s)
CPT-11
Intervention Description
Irinotecan 150mg/m2 iv on day one every two weeks until PD
Primary Outcome Measure Information:
Title
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.
Time Frame
Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization
Secondary Outcome Measure Information:
Title
Adverse events, response rates, progression free survival, time to treatment failure, change over rates to 3rd line
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masashi Fujii, M.D.,PhD
Organizational Affiliation
Surugadai Nihon University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Midori Municipal Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
458-0037
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Yamamoto Hospital
City
Noshiro
State/Province
Akita
ZIP/Postal Code
016-0014
Country
Japan
Facility Name
Hirosahi University Graduate School of Medicine
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8562
Country
Japan
Facility Name
University of Fukui Faculty of Medical Scieneces Hospital
City
Yoshida-gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Nippon Steel Yawata Memorial Hospital
City
Kitakyusyu
State/Province
Fukuoka
ZIP/Postal Code
805-8508
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Gunma University Hospital
City
Maehashi
State/Province
Gunma
ZIP/Postal Code
371-0034
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Oota
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
Fukuyama City Hospital
City
Fukuyama
State/Province
Hiroshima
ZIP/Postal Code
721-8511
Country
Japan
Facility Name
Asahikawa Medical College Department Medicine
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Asahikawa Medical College Hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Hakodate Goryoukaku Hopsital
City
Hakodate
State/Province
Hokkaido
ZIP/Postal Code
040-0001
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Hyogo Prefectural Awaji Hospital
City
Sumoto
State/Province
Hyogo
ZIP/Postal Code
656-0017
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Kanazawa Medical University Hospital
City
Kawakita
State/Province
Ishikawa
ZIP/Postal Code
920-0293
Country
Japan
Facility Name
Iwate Prefectural Central Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-0066
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Kagawa Medical University Hospital
City
Kida
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kirishima Medical Center
City
Kirishima
State/Province
Kagoshima
ZIP/Postal Code
899-5112
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
St.Marianna University School Of Medicine Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Showa University Northern Yokohama Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
224-8503
Country
Japan
Facility Name
Showa University Fujigaoka Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
227-8501
Country
Japan
Facility Name
Citizen's General Medical Center attached to Yokohama City University
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Miyagi Cancer Center
City
Natori
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Institute of Development,Aging and Cancer,Tohoku University
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Tohoku University School Of Medicine
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Sendai Medical Center
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Kaneda Hospital
City
Maniwa
State/Province
Okayama
ZIP/Postal Code
719-3105
Country
Japan
Facility Name
Rinku General Medical Center
City
Izumisano
State/Province
Osaka
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
Kimen Municipal Hospital
City
Kimen
State/Province
Osaka
ZIP/Postal Code
562-8562
Country
Japan
Facility Name
Sakai Municipal Hospital
City
Sakai
State/Province
Osaka
ZIP/Postal Code
590-0064
Country
Japan
Facility Name
Osaka Rosai Hospital
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8025
Country
Japan
Facility Name
Suita Municipal Hospital Website
City
Suita
State/Province
Osaka
ZIP/Postal Code
564-0082
Country
Japan
Facility Name
Yao City Hospital
City
Yao
State/Province
Osaka
ZIP/Postal Code
581-0069
Country
Japan
Facility Name
Saiseikai Shiga Hospital
City
Ritto
State/Province
Shiga
ZIP/Postal Code
520-3046
Country
Japan
Facility Name
Shimane University Faculty of Medicine
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Matsue City Hospital
City
Matsue
State/Province
Shimane
ZIP/Postal Code
690-8509
Country
Japan
Facility Name
Dokkyo University School of Medecine
City
Shimotsuga
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Nippon Medical School
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Surugadai Nihon University Hospital
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Toho University Ohhashi Medical Center
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
The Jikei University
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
International University of Health and Welfare Mita Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8329
Country
Japan
Facility Name
Toho University Omori Medical Center
City
Oota-ku
State/Province
Tokyo
ZIP/Postal Code
143-8541
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Tokyo Women's Medical University Institute of Gastorenterology
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Metropolitan Bokutoh Hospital
City
Sumida-ku
State/Province
Tokyo
ZIP/Postal Code
130-8575
Country
Japan
Facility Name
Tottori University Faculty of Medicine
City
Yonago
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Saiseikai Takaoka Hospital
City
Takaoka
State/Province
Toyama
ZIP/Postal Code
933-8525
Country
Japan
Facility Name
Kouseiren Takaoka Hospital
City
Takaoka
State/Province
Toyama
ZIP/Postal Code
933-8555
Country
Japan
Facility Name
Aichi Medical University Hospital
City
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Nakadoori General Hospital
City
Akita
ZIP/Postal Code
010-8577
Country
Japan
Facility Name
Aomori Prefectural Central Hospital
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
ChibaUniversity Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Fukui Red Cross Hospital
City
Fukui
ZIP/Postal Code
918-8501
Country
Japan
Facility Name
Saiseikai Hospital
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
National Kyusyu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kyusyu University Faculty of Medical Sciences
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Fukushima Medical University
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Gifu Municipal Hospital
City
Gifu
ZIP/Postal Code
500-8513
Country
Japan
Facility Name
Gifu Prefectural General Medical Center
City
Gifu
ZIP/Postal Code
500-8717
Country
Japan
Facility Name
Graduate School of Medicine, Gifu University
City
Gifu
ZIP/Postal Code
501-1193
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery
City
Hiroshima
ZIP/Postal Code
734-8553
Country
Japan
Facility Name
National Hospital Organization Kagoshima Medical Center
City
Kagoshima
ZIP/Postal Code
892-0853
Country
Japan
Facility Name
Kochi Health Sciences Center
City
Kochi
ZIP/Postal Code
781-8555
Country
Japan
Facility Name
Kumamoto Medical University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Nagano Municipal Hospital
City
Nagano
ZIP/Postal Code
381-0006
Country
Japan
Facility Name
Niigata Prefectural Cancer Center
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Kitano Hospital
City
Osaka
ZIP/Postal Code
530-8480
Country
Japan
Facility Name
Osaka City University Graduate School of Medicine
City
Osaka
ZIP/Postal Code
545-8585
Country
Japan
Facility Name
Osaka Koseinenkin Hospital
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Saga Prefectural Hospital Kouseikan
City
Saga
ZIP/Postal Code
840-8571
Country
Japan
Facility Name
Toyama Prefectural Center Hospital
City
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Yamagata University Faculty Of Medicine
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26109630
Citation
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.
Results Reference
derived

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Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer

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