UMIN ID: UMIN000002181
Registered date:10/07/2009
A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | advanced gastric cancer |
| Date of first enrollment | 2008/12/25 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | CPT-11 80mg/m2 is administered by drip infusion on day 1. TS-1 (BSA<1.25 40mg/body/once,1.25<=BSA<1.5 50mg/body/once,BSA>=1.5 60mg/body/ once) is administered twice a day orally between day 1 and day 21. It takes 35 days for the one course. |
Outcome(s)
| Primary Outcome | Patients ratio with 4 course completion |
|---|---|
| Secondary Outcome | 1.Patients ratio with one year course completion 2.Incidence of adverse events 3.Recurrence Free Survival 4. Overall Survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Ineligible criteria 1.A fresh bleeding on the digestive tract 2.Severe allergy against medicines or history of allergy 3.with active double cancer 4.with uncontrollable cavity fluid 5.with some infectious diseases and/or febrile condition 6.with brain metastases 7.with some disorders on ECG 8.with heart diseases such as congestive heart failure, symptomatic coronary dysfunction, uncontrollable arrhythmia, infarction/history of infarction 9.with liver cirrhosis and/or active hepatitis 10.with DM uncontrollable 11.with severe pulmonary diseases such as interstitial pneumonia,Pulmonary fibrosis 12.uncontrollable diarrhea 13.under intestinal paralysis or ileus 14.patients with psychological disorder who seems difficult to undergo treatment 15. under medication of ATAZANABIL 16. under continuous medication of steroids 17. with continuous medication of fluoro-pyrimidine, flusitosine, fenitoin,and/or Warfarin 18. pregnant and/or nursing women or patients who like to have children 19. patient who seems difficult to undergo protocol treatment |
Related Information
| Primary Sponsor | Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Osaka Clinical Study Supporting Organization |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Fujitani Kazumasa |
| Address | 2-1-14,Houenzaka,Chuou-ku,Osaka,540-0006 Japan |
| Telephone | 06-6942-1331 |
| Affiliation | National Hospital Organization Osaka National Hospital Dpt. surgery |
| scientific contact | |
| Name | Fujitani Kazumasa |
| Address | 2-1-14,Houenzaka,Chuou-ku,Osaka,540-0006 Japan |
| Telephone | 06-6942-1331 |
| Affiliation | National Hospital Organization Osaka National Hospital Dpt. surgery |