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Randomized Phase II Study of Gemcitabine (GEM) Versus GEM+TS-1 for Advanced Pancreatic Cancer

Phase 2
20 Years
75 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Randomized Phase II Study of Gemcitabine (GEM) Versus GEM+TS-1 for Advanced Pancreatic Cancer

Pancreatic cancer is the fifth leading cause of cancer death in the United States. It is
difficult to diagnose at its early stage and only 10-20% of patients are candidates for
resection with 5-year survival rate of less than 10%. Patients with unresectable pancreatic
cancer has a poor prognosis. Gemcitabine, a cytidine analogue, is the standard
chemotherapeutic agent for the disease with median survival time(MST) ranging from 6 to 8
months. Phase Ⅲ study showed that combinations with other drugs, such as oxaliplatine or
CDDP, did not contribute to survival time. TS-1, a new oral fluoropyrimidine which consists
of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP
(5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4
(CDHP):1(OXO), is commercially available since late 90'in Japan. Phase II trials have
demonstrated that S-1 was effective as a single agent for treatment of gastric (RR 44.6%),
colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic
cancers(20%). A combination of gemcitabine and TS-1 is found to be effective and promising
in phase Ⅱ trial for metastatic pancreatic carcinoma in selected subjects, but the
combination therapy has high rate of side effects. This phase Ⅱ randomized controlled study
compares efficacy and feasibility of GEM+S-1 with GEM alone in patients with locally
advanced and metastatic pancreatic cancer and performance status of 0-2, aiming at patients
in rather ordinary clinical settings.

Inclusion Criteria:

1. Histologically or cytologically proven unresectable pancreatic carcinoma

2. There must be measurable lesions with multislice CT

3. ECOG Performance status 0-2

4. No other active cancer

5. No previous therapy such as radiotherapy, chemotherapy and immunotherapy

6. Adequate organ functions are preserved as WBC more than 4000/mm3,Hb more than
8.0g/dl,neutrophil more than 2000/mm3,platlet more than 100,000/mm3, AST less than
2.5 x normal or less than 5.0 x normal if the patient had known liver metastasis,
bilirubin less than 2.0mg/dl, Ccr more than 60ml/min

7. No serious complications

8. Be able to eat food

9. Life expectancy of more than 8 weeks duration

10. Informed consent is obtained-

Exclusion Criteria:

1. Interstitial pneumonia

2. Uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction
with its onset within 3 months

3. Serious infection

4. Pregnant or lactating females

5. History of serious drug allergy

6. Serious other complications

7. Uncontrolled mental disorders -

Type of Study:


Study Design:

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

Outcome Measure:

response rate

Outcome Time Frame:

during observation

Safety Issue:


Principal Investigator

Takaaki Ikari, MD. PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute Ariake Hospital


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

June 2007

Completion Date:

December 2010

Related Keywords:

  • Pancreatic Cancer
  • pancreatic carcinoma
  • gemcitabine
  • S-1
  • phaseⅡstudy
  • Pancreatic Neoplasms