UMIN ID: C000000094
Registered date:30/08/2005
A phase II study of systemic chemotherapy with TS-1 and CDDP followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG0405)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | gastric neoplasm |
| Date of first enrollment | 2005/02/01 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Preoperative chemotherapy with TS-1+CDDP followed by gastrectomy with D3 lymph node dissection |
Outcome(s)
| Primary Outcome | Proportion of curative resection |
|---|---|
| Secondary Outcome | 3-year survival, proportion of completion of treatment, response rate, toxicities |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Active multiple cancer 2) Probable pregnancy, and the period of lactation 3) Difficulty to join the trial due to psychosis or psychotic symptoms 4) Under treatment with systemic steroid 5) Under treatment with flucytosine, phenytoin, or warfarin 6) Allergy to iodine 7) Serious complications 8) Past history of myocardial infarction withoin 6 months 9) Not fit to the protocol treatment by the physicion's dicision |
Related Information
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Akira Tsuburaya, MD |
| Address | 1-1-2 Nakao, Asahi-ku, Yokohama, 241-0815, JAPAN Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG0405 Coordinating Office Gastric Surgery Division, Kanagawa Cancer Center |
| scientific contact | |
| Name | Mitsuru Sasako, MD, PhD |
| Address | 1-1 Mukogawacho, Nishinomiya, Hyogo, Japan Japan |
| Telephone | |
| Affiliation | Hyogo College of Medicine Upper GI Surgery Division |