Phase III of Gemcitabine Vs TS-1 Vs Gemcitabine Plus TS-1 in Pancreatic Cancer

Inclusion Criteria:

• Pancreatic carcinoma histologically determined to be adenocarcinoma or adenosquamouscarcinoma.

• Advanced unresectable pancreatic (including pancreatic cancer with local progressionand recurrent pancreatic cancer).Presence/absence of measurable lesions is notconsidered. Patients with measurable lesions must undergo diagnostic imaging testswithin 28 days before registration.

• Patients with no previous treatment (radiotherapy,chemotherapy etc) for pancreaticcancer, except resection. Intra-operative radiotherapy during resection of pancreaticcancer will be permitted, although registration must occur at least 4 weeks after theradiotherapy. Patients that have undergone preoperative/postoperative adjuvantchemotherapy may be enrolled if relapse is diagnosed beyond week 24 after the finaladministration (on day 169 when the day following the final day is set as day 1).

• Age: 20 years to 79 years.

• ECOG Performance Status (PS) of 0 or 1.

• Sufficient function of major organs as defined below. (The following criteria aresatisfied in laboratory tests conducted within 14 days before registration. Laboratorytests conducted 2 weeks before registration (on the same weekday) will be included.)White blood cell count≥ 3500/mm3 Neutrophil count≥ 2000/mm3 Hemoglobin≥9.0 g/dLPlatelet count≥100000/mm3 Total bilirubin≤ 2.0 mg/dL* ≤ 3.0 mg/dL in patients treatedby biliary drainage for obstructive jaundice. AST and ALT≤ 150 U/L Serumcreatinine≤1.2 mg/dL Creatinine clearance≥50mL/min.* **Measured values will be usedif available. Otherwise, values calculated by the Cockcroft-Gault method will beused.Formula for estimation:body weight (kg) x [140 - age (years) / 72 x serumcreatinine (mg/dL)] *Estimated value will be multiplied by 0.85 for females.

• Able to take capsules orally.

• No clinically abnormal ECG findings within 28 days (4 weeks)before registration.

• Voluntarily signed the written consent form.

Exclusion Criteria:

• Pulmonary fibrosis or interstitial pneumonia (to be confirmed by chest X-ray within 28days before enrollment).

• Watery diarrhoea.

• Active infections (e.g. patients with pyrexia of 38°C or greater), excluding viralhepatitis.

• Serious complications (e.g. heart failure, renal failure,hepatic failure, haemorrhagicpeptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlleddiabetes).

• Moderate or severe (requiring drainage) ascites or pleural effusion requiringtreatment.

• Metastasis in the CNS.

• Active double cancer (synchronous double cancer or asynchronous double cancer withdisease-free duration of 3 years or less). Carcinoma in situ and lesions ofintramucosal carcinoma will not be included in active double cancer and will bepermitted for registration.

• Patients under treatment with flucytosine, phenytoin or warfarin potassium.

• Pregnant females, possibly pregnant females, females wishing to become pregnant andnursing mothers. Males that are currently attempting to produce a pregnancy.

• Severe mental disorder.

• Judged ineligible by physicians for participation in the study from a safetyviewpoint.