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Randomized Phase III Study of Gemcitabine Versus TS-1 Versus Gemcitabine Plus TS-1 in Unresectable Advanced Pancreatic Cancer (With Local Progression or Metastasis)

Phase 3
20 Years
79 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

Randomized Phase III Study of Gemcitabine Versus TS-1 Versus Gemcitabine Plus TS-1 in Unresectable Advanced Pancreatic Cancer (With Local Progression or Metastasis)

Inclusion Criteria:

- Pancreatic carcinoma histologically determined to be adenocarcinoma or adenosquamous

- Advanced unresectable pancreatic (including pancreatic cancer with local progression
and recurrent pancreatic cancer).Presence/absence of measurable lesions is not
considered. Patients with measurable lesions must undergo diagnostic imaging tests
within 28 days before registration.

- Patients with no previous treatment (radiotherapy,chemotherapy etc) for pancreatic
cancer, except resection. Intra-operative radiotherapy during resection of pancreatic
cancer will be permitted, although registration must occur at least 4 weeks after the
radiotherapy. Patients that have undergone preoperative/postoperative adjuvant
chemotherapy may be enrolled if relapse is diagnosed beyond week 24 after the final
administration (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 are
satisfied in laboratory tests conducted within 14 days before registration.
Laboratory tests 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/dL Platelet count≥100000/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.** **Measured values will be used
if available. Otherwise, values calculated by the Cockcroft-Gault method will be
used.Formula for estimation:body weight (kg) x [140 - age (years) / 72 x serum
creatinine (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
28 days before enrollment).

- Watery diarrhoea.

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

- Serious complications (e.g. heart failure, renal failure,hepatic failure,
haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly
controlled diabetes).

- Moderate or severe (requiring drainage) ascites or pleural effusion requiring

- Metastasis in the CNS.

- 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.

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

- Pregnant females, possibly pregnant females, females wishing to become pregnant and
nursing mothers. Males that are currently attempting to produce a pregnancy.

- Severe mental disorder.

- Judged ineligible by physicians for participation in the study from a safety

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Over all survival(OS)

Outcome Time Frame:

every course for first three courses, then every other course

Safety Issue:


Principal Investigator

Takuji Okusaka, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center Hospital


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

July 2007

Completion Date:

June 2012

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Pancreatic Neoplasms