A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer

This study is currently recruiting participants.
Verified June 2010 by Japan Clinical Oncology Group
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00252161
First received: November 10, 2005
Last updated: June 13, 2010
Last verified: June 2010
  Purpose

The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone.


Condition Intervention Phase
Gastric Neoplasm
Procedure: Gastrectomy with more than D2 dissection
Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • overall survival [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival (PFS) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • proportion of protocol achievement [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • proportion of curative resection [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 316
Study Start Date: November 2005
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Procedure/Surgery: Gastrectomy with more than D2 dissection
Procedure: Gastrectomy with more than D2 dissection
Gastrectomy with more than D2 dissection
Experimental: 2
Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

Detailed Description:

A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions within five years. The primary endpoint is overall survival. The secondary endpoints are progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. histologically proven adenocarcinoma of stomach
  2. Borrmann type 4 or large (>=8 cm) type 3
  3. no evidence of distant metastasis including liver(M0)
  4. no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2)
  5. no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation
  6. no involvement of the esophagus with > 3cm
  7. an age of 20-75 years
  8. an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  9. no prior chemotherapy, radiotherapy for any malignancy
  10. no prior surgery for gastric cancer except for endoscopic membrane resection (EMR)
  11. no breeding from primary tumor or gastrointestinal stenosis
  12. sufficient oral intake
  13. adequate organ function
  14. written informed consent

Exclusion Criteria:

  1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
  2. pregnant or breast-feeding women
  3. severe mental disease
  4. systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
  5. other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
  6. myocardial infarction within six disease-free months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252161

Contacts
Contact: Yoshiaki Iwasaki, MD, PhD 81-3-3823-2101 JCOG_sir@ml.jcog.jp
Contact: Kuniyoshi Arai, MD, PhD 81-3-3823-2101 JCOG_sir@ml.jcog.jp

Locations
Japan
Aichi Cancer Center Hospital Recruiting
1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681
Contact: Seiji Itoh, M.D.    81-52-762-6111      
Fujita Health University Recruiting
1-98,Dengakugakubo,Kutsukake-cho,Toyoake, Aichi, Japan, 470-1192
Contact: Ichiro Uyama, M.D.,Ph.D.    81-562-93-9254      
National Cancer Center Hospital East Recruiting
6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577
Contact: Taira Kinoshita, M.D.    81-471-33-1111      
National Hospital Organization Shikoku Cancer Center Recruiting
13,Horinouchi,Matsuyama, Ehime, Japan, 790-0007
Contact: Yoshiro Kubo, M.D., Ph.D.    81-89-932-1111      
Gifu Municipal Hospital Recruiting
7-1,Kashima-cho,Gifu, Gifu, Japan, 500-8323
Contact: Hiroo Ohshita, M.D.    81-58-251-1101      
Hiroshima City Hospital Recruiting
7-33,Motomachi,Naka-ku,Hiroshima, Hiroshima, Japan, 730-8518
Contact: Masahiko Nishizaki, M.D., Ph.D.    81-82-221-2291      
Itami City Hospital Recruiting
1-100,Koyaike,Itami, Hyogo, Japan, 664-8540
Contact: Masahiro Hiratsuka, M.D., Ph.D.    81-72-777-3773      
Iwate Medical University Recruiting
19-1,Uchimaru,Morioka, Iwate, Japan, 020-8505
Contact: Takagane Akinori, M.D., Ph.D.    81-19-651-5111      
Kagoshima University,Faculty of Medicine Recruiting
8-35-1,Sakuragaoka,Kagoshima, Kagoshima, Japan, 890-8520
Contact: Akihiro Nakajoh, M.D.    81-99-275-5361      
Kanagawa Cancer Center Recruiting
1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0815
Contact: Takaki Yoshikawa, M.D., Ph.D.    81-45-391-5761      
Kyoto Second Red Cross Hospital Recruiting
355-5,Kamanza-Marutamachi,Kamigyo-ku, Kyoto, Japan, 602-8026
Contact: Masataka Shimotsuma, M.D., Ph.D.    81-75-231-5171      
National Hospital Organization, Sendai Medical Center Recruiting
2-8-8,Miyagino,Miyagino-ku,Sendai, Miyagi, Japan, 983-8520
Contact: Shin Teshima, M.D.    81-22-293-1111      
Miyagi Cancer Center Recruiting
47-1,Nodayama,Medeshima-Shiode,Natori, Miyagi, Japan, 981-1293
Contact: Hideaki Yamanami, M.D.,Ph.D.    81-22-384-3151      
Niigata Cancer Center Hospital Recruiting
2-15-3,Kawagishi-cho,Niigata, Niigata, Japan, 951-8566
Contact: Hiroshi Yabusaki, M.D.    81-25-266-5111      
Nagaoka Chuo General Hospital Recruiting
2041,Kawasaki,Nagaoka, Niigata, Japan, 940-8653
Contact: Yasuyuki Kawachi, M.D.    81-258-35-3700      
Tsubame Rosai Hospital Recruiting
633,Sawatari,Tsubame, Niigata, Japan, 959-1228
Contact: Kikuo Aizawa, M.D.    81-256-64-5111      
Oita University Fuculty of Medicine Recruiting
1-1,Oogaoka,Hasama-machi,Oita, Oita, Japan, 879-5593
Contact: Norio Shiraishi, M.D.    81-97-586-5843      
Sakai Municipal Hospital Recruiting
1-1-1,Minamiyasuicho,Sakai, Osaka, Japan, 590-0064
Contact: Hiroshi Imamura, M.D., Ph.D.    81-72-221-1700      
Osaka Medical Center for Cancer and Cardiovascular Diseases Recruiting
1-3-3,Nakamichi,Higashinari-ku,Osaka, Osaka, Japan, 537-8511
Contact: Isao Miyashiro, M.D., Ph.D.    81-6-6972-1181      
Osaka National Hospital Recruiting
2-1-14,Hoenzaka,Chuo-ku,Osaka, Osaka, Japan, 540-0006
Contact: Motohiro Hirao, M.D.    81-6-6942-1331      
Osaka Medical College Recruiting
2-7,Daigakucho,Takatsuki, Osaka, Japan, 569-0801
Contact: Eiji Nomura, M.D.    81-72-683-1221      
Kinki University School of Medicine Recruiting
377-2,Ohno-higashi,Osaka-Sayama, Osaka, Japan, 589-8511
Contact: Hironori Shigeoka, M.D., Ph.D.    81-72-366-0221      
Toyonaka Municipal Hospital Recruiting
4-14-1,Shibaharacho,Toyonaka, Osaka, Japan, 560-0055
Contact: Junya Fujita, M.D.    81-6-6843-0101      
National Defense Medical College Recruiting
3-2,Namiki,Tokorozawa, Saitama, Japan, 359-8513
Contact: Takashi Ichikura, M.D.    81-4-2995-1637      
Saitama Cancer Center Recruiting
818,Komuro,Ina,Kita-adachi, Saitama, Japan, 362-0806
Contact: Yoshiyuki Kawashima, M.D.    81-48-722-1111      
Shizuoka General Hospital Recruiting
4-27-1,Kitaando,Aoi-ku,Shizuoka, Sizuoka, Japan, 420-8527
Contact: Masakazu Takagi, M.D.    81-54-247-6111      
International Medical Center of Japan Recruiting
1-21-1,Toyama,Shinjuku-ku, Tokyo, Japan, 162-8655
Contact: Toshio Shimizu, M.D.    81-3-3202-7181      
Tokyo Medical and Dental University Hospital Recruiting
1-5-45,Yushima,Bunkyo-ku, Tokyo, Japan, 113-8519
Contact: Kazuyuki Kojima, M.D.    81-3-5803-5261      
Cancer Institute Hospital Recruiting
3-10-6,Ariake,Koto-ku, Tokyo, Japan, 135-8550
Contact: Yasuyuki Seto, M.D., Ph.D.    81-3-3520-0111      
Tokyo Metropolitan Komagome Hospital Recruiting
3-18-22,Honkomagome,Bunkyo-ku, Tokyo, Japan, 113-8677
Contact: Yoshiaki Iwasaki, M.D.    81-3-3823-2101      
Tokyo Metropolitan Bokutoh Hospital Recruiting
4-23-15,Koutoubashi,Sumida-ku, Tokyo, Japan, 130-8575
Contact: Satoru Inoue, M.D.    81-3-3633-6151      
National Cancer Center Hospital Recruiting
5-1-1,Tsukiji,Chuo-ku, Tokyo, Japan, 104-0045
Contact: Takeshi Sano    81-3-3542-2511      
Toyama Prefectural Central Hospital Recruiting
2-2-78,nishinagae,Toyama, Toyama, Japan, 930-8550
Contact: Masahide Kaji, M.D., Ph.D.    81-76-424-1531      
Wakayama Medical University, School of Medicine Recruiting
811-1,Kimiidera,Wakayama, Wakayama, Japan, 641-8510
Contact: Makoto Iwahashi, M.D., Ph.D.    81-73-441-0612      
Yamagata Prefectural Central Hospital Recruiting
1800,Aoyagi,Yamagata, Yamagata, Japan, 990-2292
Contact: Norimasa Fukushima, M.D.    81-23-685-2626      
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Mitsuru Sasako, MD, PhD Hyogo College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Mitsuru Sasako, MD, PhD, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00252161     History of Changes
Other Study ID Numbers: JCOG0501, C000000279
Study First Received: November 10, 2005
Last Updated: June 13, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
Neoadjuvant Therapy
Stomach Neoplasms
Cisplatin
S-1(combination)

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014