pancreatic cancer
Conditions
Interventions
GEM 1,000mg/m2 day1 TS-1 50-120mg/day alternate-day (Mondays, Wednesdays, Fridays and Sundays) q2W
Sponsors
Fukushima medical University Hospital, School of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Either histologically or cytologically confirmed adenocarcinoma and adenosquamous carcinoma. Or radiologically confirmed pancreatic cancer. (2)Unresectable pancreatic cancer (including locally advanced or metastatic pancreatic cancer). (3)Patients with no previous treatment (radiotherapy, chemotherapy etc) for pancreatic cancer, except resection. Palliative bypass operation and biliary stent will be permitted. Intra-operative radiotherapy during resection of pancreatic cancer will be permitted, although registration must be done at least 4 weeks after the radiotherapy. Patients who have undergone preoperative/postoperative adjuvant chemotherapy can be enrolled if relapse is diagnosed beyond 24 weeks (168days) after the final administration. (4)Patients with measurable lesions (5)Age of 20 years or older. (6)ECOG Performance Status (PS) of 0 or 1. (7)Adequate major organ functions within 14 days before registration, as defined below: White blood cell count >= 3500/mm3 Neutrophil count >= 2000/mm3 Hemoglobin >= 9.0 g/dL Platelet count >= 100,000/mm3 Total bilirubin <= 2.0 mg/dL* *3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice. AST and ALT <= 150 U/L Serum creatinine <= 1.2 mg/dL Creatinine clearance <= 50mL/min. (8) Sufficient oral intake. (9) No clinically abnormal ECG findings within 28 days (4 weeks) before registration. (10) Patients must have signed an informed consent document.
Exclusion criteria
Exclusion criteria: (1) Contraindication of Gemsitabine and S-1. (2) Pulmonary fibrosis or interstitial pneumonia (to be confirmed by chest X-ray within 28 days before registration). (3)Watery diarrhea. (4)Active infections (e.g. patients with pyrexia of 38 degree centigrade or greater), excluding viral hepatitis. (5)Serious complications (e.g. heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes). (6)Moderate or severe (requiring drainage) ascites or pleural effusion requiring treatment. (7) Metastasis in the CNS. (8) 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. (9) Current use of flucytosine, phenytoin or warfarin potassium. (10) For female subject: Positive Pregnancy test, presently breast feeding or unwilling to use effective contraceptive measure. For male subjects: intent to procreate during the duration of the study or unwilling to use effective contraceptive measure. (11) Severe mental disorder. (12) Severe drug allergies. (13)Decision of not eligible determined by principle investigator or attending doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Progression-free Survival Disease Control Rate Safety | — |
Countries
Japan
Contacts
Public ContactTakao Tsuchiya
Fukushima Medical University Hospital, School of medicine Department of Regenerative Surgery
Outcome results
None listed