Feasibility study of adjuvant chemotherapy with alternate-day administrations of S-1 in patients with resected pancreatic cancer
- Conditions
- pancreatic cancer
- Registration Number
- JPRN-UMIN000009936
- Lead Sponsor
- Fukushima Medical University Hospital, School of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1) Contraindication of S-1 2) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 3 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration 3)Pulmonary fibrosis or interstitial pneumonia 4)Watery diarrhea 5)Active infections (e.g. patients with pyrexia of 38 degree centigrade or greater), excluding viral hepatitis 6)Serious complications (e.g. heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes). 7)Moderate or severe (requiring drainage) ascites or pleural effusion 8) Current use of flucytosine 9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 10) Severe mental disorder. 11) Severe drug allergies. 12) Positive HBs antigen and/or HCV antibody. 13)Physician concludes that the patient's participation in this trial is inappropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment completion rate
- Secondary Outcome Measures
Name Time Method Overall Survival Relapse-free Survival Incidence and Severity of Adverse Events