GEM vs GEM+TS-1 for Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable pancreatic cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Clinical Cancer Research Organization
• Treatments: Gemcitabine

Criteria

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 -