Clinical trial NCT00252161: A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Neoplasm
Keywords: Neoadjuvant Therapy
Stomach Neoplasms
Cisplatin
S-1(combination)
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-11-11
Enrollment: 316
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: overall survival
timeFrame: during the study conduct
Secondary outcomes:
measure: progression free survival (PFS)
timeFrame: during the study conduct
measure: response rate
timeFrame: during the study conduct
measure: proportion of protocol achievement
timeFrame: during the study conduct
measure: proportion of curative resection
timeFrame: during the study conduct
measure: adverse events
timeFrame: during the study conduct
Other outcomes:
Locations:
city: Nagoya,Chikusa-ku,Kanokoden,1-1
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Toyoake,Kutsukake-cho,Dengakugakubo,1-98
country: Japan
facility: Fujita Health University
state: Aichi
city: Kashiwa,Kashiwanoha,6-5-1
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama,Horinouchi,13
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Gifu,Kashima-cho,7-1
country: Japan
facility: Gifu Municipal Hospital
state: Gifu
city: Hiroshima,Naka-ku,Motomachi,7-33
country: Japan
facility: Hiroshima City Hospital
state: Hiroshima
city: Itami,Koyaike,1-100
country: Japan
facility: Itami City Hospital
state: Hyogo
city: Morioka,Uchimaru,19-1
country: Japan
facility: Iwate Medical University
state: Iwate
city: Kagoshima,Sakuragaoka,8-35-1
country: Japan
facility: Kagoshima University,Faculty of Medicine
state: Kagoshima
city: Yokohama,Asahi-ku,Nakao,1-1-2
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Kamigyo-ku,Kamanza-Marutamachi,355-5
country: Japan
facility: Kyoto Second Red Cross Hospital
state: Kyoto
city: Natori,Medeshima-Shiode,Nodayama,47-1
country: Japan
facility: Miyagi Cancer Center
state: Miyagi
city: Sendai,Miyagino-ku,Miyagino,2-8-8
country: Japan
facility: National Hospital Organization, Sendai Medical Center
state: Miyagi
city: Nagaoka,Kawasaki,2041
country: Japan
facility: Nagaoka Chuo General Hospital
state: Niigata
city: Niigata,Kawagishi-cho,2-15-3
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Tsubame,Sawatari,633
country: Japan
facility: Tsubame Rosai Hospital
state: Niigata
city: Oita,Hasama-machi,Oogaoka,1-1
country: Japan
facility: Oita University Fuculty of Medicine
state: Oita
city: Osaka,Chuo-ku,Hoenzaka,2-1-14
country: Japan
facility: Osaka National Hospital
state: Osaka
city: Osaka,Higashinari-ku,Nakamichi,1-3-3
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
state: Osaka
city: Osaka-Sayama,Ohno-higashi,377-2
country: Japan
facility: Kinki University School of Medicine
state: Osaka
city: Sakai,Minamiyasuicho,1-1-1
country: Japan
facility: Sakai Municipal Hospital
state: Osaka
city: Takatsuki,Daigakucho,2-7
country: Japan
facility: Osaka Medical College
state: Osaka
city: Toyonaka,Shibaharacho,4-14-1
country: Japan
facility: Toyonaka Municipal Hospital
state: Osaka
city: Kita-adachi,Ina,Komuro,818
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Tokorozawa,Namiki,3-2
country: Japan
facility: National Defense Medical College
state: Saitama
city: Shizuoka,Aoi-ku,Kitaando,4-27-1
country: Japan
facility: Shizuoka General Hospital
state: Sizuoka
city: Bunkyo-ku,Honkomagome,3-18-22
country: Japan
facility: Tokyo Metropolitan Komagome Hospital
state: Tokyo
city: Bunkyo-ku,Yushima,1-5-45
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Chuo-ku,Tsukiji,5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku,Ariake,3-10-6
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: Shinjuku-ku,Toyama,1-21-1
country: Japan
facility: International Medical Center of Japan
state: Tokyo
city: Sumida-ku,Koutoubashi,4-23-15
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital
state: Tokyo
city: Toyama,nishinagae,2-2-78
country: Japan
facility: Toyama Prefectural Central Hospital
state: Toyama
city: Wakayama,Kimiidera,811-1
country: Japan
facility: Wakayama Medical University, School of Medicine
state: Wakayama
city: Yamagata,Aoyagi,1800
country: Japan
facility: Yamagata Prefectural Central Hospital
state: Yamagata
Study officials:
affiliation: Hyogo Medical University
name: Mitsuru Sasako, MD, PhD
role: STUDY_CHAIR
References: