Phase II study of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced adenocarcinoma of the gastric or esophagogastric junction(KSCC 1601)
- Conditions
- Gastric cancer Esophagogastric junction cancer
- Registration Number
- JPRN-UMIN000021061
- Lead Sponsor
- Kyushu Study group of Clinical Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 47
Not provided
1) Severe drug hypersensitivity (particularly to platinum analogs, 5-FU, or S-1) 2) Peripheral neuropathy affecting the sensory nerves (Grade 1 or worse) 3) Active infection 4) Uncontrollable hypertension 5) Uncontrollable diabetes mellitus or routine administration of insulin 6) Heart disease that may pose a problem 7) Severe pulmonary disease 8) Severe mental disease 9) Active gastrointestinal tract bleeding requiring repeated transfusions 10) Under treatment with phenytoin, warfarin or flucytosine 11) Watery diarrhea (Grade 2 or worse) 12) Synchronous or metachronous malignancies other than carcinoma in situ or mucosal cancer 13) A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner 14) Cirrhosis or hepatitis 15) Patients judged by the investigator as unfit to be enrolled in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological response rate
- Secondary Outcome Measures
Name Time Method Anastomotic leakage of tumours are classified as Siewert Type II and Type III Overall survival Complete resection rate, resection rate Relapse free survival Response rate Adverse events Surgical complecations