The feasibility study of TAS-118 plus Oxaliplatin or TAS-118 monotherapy as perioperative chemotherapy for locally advanced gastric cancer
- Conditions
- Resectable gastric cancer
- Registration Number
- JPRN-UMIN000024688
- Lead Sponsor
- The Cancer Institute Hospital of JFCR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
(1)Be sensitive seriously to ingredients of TAS-118 or Oxaliplatin (2)Be received blood transfusion, blood products and hematopoietic agents such as G-CSF within 2 weeks prior to registration (3)Be under medication with warfarin, phenytoin, flucytosine at registration (4)Have poorly controlled diarrhea (liquid stool, difficult bowel control by medical treatment, => Grade 2, defecation frequency of => 5 times/day, etc.) (5)Have peripheral sensory neuropathy or paraesthesia of => Grade 2 (6)Be with present or past history of sever pulmonary diseases (7)Be with severe (=> Grade 3, etc.) cardiac disease, or experienced cardiac infarction and/or angina within 6 months prior to registration (8)Be with diabetes mellitus poorly controlled by medical therapy or accompanying severe diabetic complications (9)Be with severe (=> Grade 3, etc.) complications (10)Be positive to HIV, or with active hepatitis (11)Be with active infections, inflammatory diseases or collagen diseases (12)Be requiring or receiving continuous systemic administration of steroids (oral or intravenous). (13)Be with active (=> Grade 3, etc.) gastrointestinal hemorrhage (14)Be with simultaneously active multiple primary cancer (simultaneous multiple cancer, and metachronous multiple primary cancers with <= 5 years disease-free period. Carcinoma in situ and lesions corresponding to intra-mucosal carcinoma judged to be cured with local therapy are not included in an active multiple cancer). (15)Females who are pregnant, nursing and possibly pregnant, or not agree to contraception during the administration period and a certain period (6 months) after the final administration of investigational product. Females of childbearing potential must have a negative pregnancy test (16)Be judged difficult to participate in the study due to mental disease or complicating psychiatric symptoms (17)Be judged not to be suitable to participate in the study by principle investigator (co-investigator)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Feasibility of preoperative adjuvant chemotherapy with TAS-118 plus Oxaliplatin and gastrectomy (Step 1/2) -Feasibility of postoperative adjuvant chemotherapy with TAS-118 alone (Step 1) -Feasibility of postoperative adjuvant chemotherapy with TAS-118 plus Oxaliplatin (Step 2)
- Secondary Outcome Measures
Name Time Method