advanced pancreatic cancer
Conditions
Interventions
TS-1 will be orally administered twice daily (after breakfast and supper) for 14 consecutive days at one of the doses (50mg, 80 mg, 100 mg, 120 mg/day) adjusted for body surface area, then withdrawn f
Sponsors
Gifu University Hospital
Gifu Prefectural Medical Center Gifu Municipal Hospital Kurume University Hospital Japanese Red Cross Nagoya Daini Hospital Nagoya City University Hospital Mie University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pancreatic carcinoma histologically determined to be adenocarcinoma or adenosquamous carcinoma. 2) Advanced unresectable pancreatic cancer. 3) Patients with no previous treatment (radiotherapy, chemotherapy etc) for pancreatic cancer, except resection. 4) Age: between 20 and 79 years at registration. 5) ECOG Performance Status (PS) of 0 or 1. 6) Sufficient function of major organs as defined below. White blood cell count: 3500/mm3 Neutrophil count: 2000/mm3 Hemoglobin: 9.0 g/dL Platelet count: 100000/mm3 Total bilirubin: 2.0 mg/dL AST and ALT: 150 U/L Serum creatinine: 1.2 mg/dL Creatinine clearance: 50mL/min 7) Able to take capsules orally. 8) No clinically abnormal ECG findings within 28 days before registration. 9) Voluntarily signed the written consent form.
Exclusion criteria
Exclusion criteria: 1) Pulmonary fibrosis or interstitial pneumonia. 2) Watery diarrhoea. 3) Active infections, excluding viral hepatitis. 4) Serious complications (e.g. heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes). 5) Moderate or severe ascites or pleural effusion requiring treatment. 6) Metastasis in the CNS. 7) Active double cancer. 8) Patients under treatment with flucytosine, phenytoin or warfarin potassium. 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) Judged ineligible by physicians for participation in the study from a safety viewpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Response rate Safety | — |
Countries
Japan
Contacts
Public ContactShinpei Doi
Gifu University graduate school of medicine Department of Gastroenterology
Outcome results
None listed