Gastric Neoplasm Clinical Trial
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)
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.
Status | Completed |
Enrollment | 316 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Tokyo Metropolitan Komagome Hospital | Bunkyo-ku,Honkomagome,3-18-22 | Tokyo |
Japan | Tokyo Medical and Dental University Hospital | Bunkyo-ku,Yushima,1-5-45 | Tokyo |
Japan | National Cancer Center Hospital | Chuo-ku,Tsukiji,5-1-1 | Tokyo |
Japan | Gifu Municipal Hospital | Gifu,Kashima-cho,7-1 | Gifu |
Japan | Hiroshima City Hospital | Hiroshima,Naka-ku,Motomachi,7-33 | Hiroshima |
Japan | Itami City Hospital | Itami,Koyaike,1-100 | Hyogo |
Japan | Kagoshima University,Faculty of Medicine | Kagoshima,Sakuragaoka,8-35-1 | Kagoshima |
Japan | Kyoto Second Red Cross Hospital | Kamigyo-ku,Kamanza-Marutamachi,355-5 | Kyoto |
Japan | National Cancer Center Hospital East | Kashiwa,Kashiwanoha,6-5-1 | Chiba |
Japan | Saitama Cancer Center | Kita-adachi,Ina,Komuro,818 | Saitama |
Japan | Cancer Institute Hospital | Koto-ku,Ariake,3-10-6 | Tokyo |
Japan | National Hospital Organization Shikoku Cancer Center | Matsuyama,Horinouchi,13 | Ehime |
Japan | Iwate Medical University | Morioka,Uchimaru,19-1 | Iwate |
Japan | Nagaoka Chuo General Hospital | Nagaoka,Kawasaki,2041 | Niigata |
Japan | Aichi Cancer Center Hospital | Nagoya,Chikusa-ku,Kanokoden,1-1 | Aichi |
Japan | Miyagi Cancer Center | Natori,Medeshima-Shiode,Nodayama,47-1 | Miyagi |
Japan | Niigata Cancer Center Hospital | Niigata,Kawagishi-cho,2-15-3 | Niigata |
Japan | Oita University Fuculty of Medicine | Oita,Hasama-machi,Oogaoka,1-1 | Oita |
Japan | Osaka National Hospital | Osaka,Chuo-ku,Hoenzaka,2-1-14 | Osaka |
Japan | Osaka Medical Center for Cancer and Cardiovascular Diseases | Osaka,Higashinari-ku,Nakamichi,1-3-3 | Osaka |
Japan | Kinki University School of Medicine | Osaka-Sayama,Ohno-higashi,377-2 | Osaka |
Japan | Sakai Municipal Hospital | Sakai,Minamiyasuicho,1-1-1 | Osaka |
Japan | National Hospital Organization, Sendai Medical Center | Sendai,Miyagino-ku,Miyagino,2-8-8 | Miyagi |
Japan | International Medical Center of Japan | Shinjuku-ku,Toyama,1-21-1 | Tokyo |
Japan | Shizuoka General Hospital | Shizuoka,Aoi-ku,Kitaando,4-27-1 | Sizuoka |
Japan | Tokyo Metropolitan Bokutoh Hospital | Sumida-ku,Koutoubashi,4-23-15 | Tokyo |
Japan | Osaka Medical College | Takatsuki,Daigakucho,2-7 | Osaka |
Japan | National Defense Medical College | Tokorozawa,Namiki,3-2 | Saitama |
Japan | Toyama Prefectural Central Hospital | Toyama,nishinagae,2-2-78 | Toyama |
Japan | Fujita Health University | Toyoake,Kutsukake-cho,Dengakugakubo,1-98 | Aichi |
Japan | Toyonaka Municipal Hospital | Toyonaka,Shibaharacho,4-14-1 | Osaka |
Japan | Tsubame Rosai Hospital | Tsubame,Sawatari,633 | Niigata |
Japan | Wakayama Medical University, School of Medicine | Wakayama,Kimiidera,811-1 | Wakayama |
Japan | Yamagata Prefectural Central Hospital | Yamagata,Aoyagi,1800 | Yamagata |
Japan | Kanagawa Cancer Center | Yokohama,Asahi-ku,Nakao,1-1-2 | Kanagawa |
Lead Sponsor | Collaborator |
---|---|
Haruhiko Fukuda | Ministry of Health, Labour and Welfare, Japan |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall survival | during the study conduct | No | |
Secondary | progression free survival (PFS) | during the study conduct | No | |
Secondary | response rate | during the study conduct | No | |
Secondary | proportion of protocol achievement | during the study conduct | No | |
Secondary | proportion of curative resection | during the study conduct | No | |
Secondary | adverse events | during the study conduct | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02543411 -
Use of Lidocaine in Endoscopic Submucosal Dissection
|
N/A | |
Completed |
NCT02128243 -
Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
|
Phase 2 | |
Active, not recruiting |
NCT00506207 -
A Phase I Study of S-1 Plus Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy
|
Phase 1 | |
Completed |
NCT04830618 -
Aberrant DNA Methylation to Predict Metachronous Gastric Neoplasms
|
||
Completed |
NCT02235246 -
The Effect of Perioperative Intravenous Magnesium on Pain After Endoscopic Submucosal Dissection for Gastric Neoplasm: Prospective Randomized Double-blind Placebo Controlled Study
|
Phase 4 | |
Recruiting |
NCT04622098 -
Prevalence of Sub-epithelial Lesions Among Patients Undergoing EGDs in Egypt
|
||
Terminated |
NCT01870791 -
Study of Additive Omega-3 Fish Oil to Palliative Chemotherapy to Treat Oesophagogastric Cancer
|
Phase 2 | |
Completed |
NCT03255070 -
A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)
|
Phase 1 | |
Recruiting |
NCT06342427 -
Stomach Cancer Exosome-based Detection
|
||
Recruiting |
NCT04780256 -
Endoscopic Resection of Gastrointestinal Neoplasms
|
||
Recruiting |
NCT03065257 -
Endoscopic Resection Multicenter Registry
|
N/A | |
Recruiting |
NCT05804331 -
The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
|
||
Completed |
NCT05265221 -
Learning Curve for Gastric Endoscopic Submucosal Dissection
|
||
Recruiting |
NCT03597581 -
A Study of RGX-202-01 (Ompenaclid) as Combination Therapy in RAS Mutant Advanced Colorectal Cancer
|
Phase 1 | |
Completed |
NCT00112099 -
GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
|
Phase 3 | |
Recruiting |
NCT04466631 -
Health and Employment After Gastro Intestinal Surgery - HEAGIS2
|
||
Completed |
NCT00149279 -
A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer
|
Phase 3 | |
Terminated |
NCT00149266 -
Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)
|
Phase 3 | |
Recruiting |
NCT06362070 -
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy
|
N/A | |
Completed |
NCT01824953 -
Long-term Follow-up Prognosis of Atrophic Gastritis After 3 Years
|
N/A |