Resectable gastric cancer
Conditions
Interventions
TAS-118/Oxaliplatin
Sponsors
The Cancer Institute Hospital of JFCR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients satisfying all of the following criteria during baseline observation period will be considered as eligible patients in this study (1)Be confirmed as gastric cancer histopathologically (in any of the histological types) (2)Be diagnosed with cT3-4N1-3M0 on image findings (Japanese Classification of Gastric Carcinoma, 14th Edition) (3)Be with swelling of stomach-regional lymph node of =>8 mm minor axis or =>10 mm major axis (4)Be with no metastasis to Bulky lymph node on CT scanning of upper abdomen (5)Be with no distant metastasis on diagnostic laparoscopy, and negative for peritoneal lavage cytology (6)Be aged of 20-79 years at registration (7)Be with no history of medical treatment to gastric cancer (radiation therapy, chemotherapy,hormone therapy, etc.) (8)Be acceptable for sufficient oral treatment (9)Be with ECOG performance status 0 or 1 (10)Be confirmed that major organic functions are maintained by laboratory test performed within 14 days prior registrationSatisfy the following criteria: -WBC count: => 3000/mm3 and <= 12000/mm3 -Neutrophil count: => 2000/mm3 -Platelet count: => 100000/mm3 -Hemoglobin: => 9.0 g/dL -Total bilirubin: <= 1.5 mg/dL -AST(GOT): <= 100 units/L -ALT(GPT): <= 100 units/L -Serum Creatinine: <= 1.3 mg/dL -CCR: => 60 mL/min (Cockcroft-Gault estimation formula) (11)Be explained about this clinical trial with informed consent form and submitted informed consent in writing
Exclusion criteria
Exclusion criteria: (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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -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) | — |
Countries
Japan
Contacts
Public ContactDaisuke Takahari
The Cancer Institute Hospital of JFCR Gastroenterology Center Gastroenterology medical oncology
Outcome results
None listed