A randomized phase II trial of adjuvant Chemotherapy with Gemcitabine alone, S-1 alone, versus gemcitabine and S-1 in patients with resected pancreatic cancer

UMIN ID: UMIN000002000

Registered date:25/05/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Incasive ductal carcinoma of pancreas with macroscopic complete resection
• Date of first enrollment: 2007/01/01
• Target sample size: 96
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Gemcitabine adjuvant chemotherapy: Three weekly infusions of gemcitabine at 1000mg/m2 followed by 1week pause as 1 course. total 12 courses
S-1 adjuvant chemotherapy: S-1 80mg/m2/day for 14days followed by 1week pause as 1 course. total 16 courses
Gemcitabine and S-1 combination adjuvant chemotherapy: S-1 60mg/m2/day for 14days and gemcitabine 1000mg/m2 at day8 and 15 within 21days as 1 course. total 16 courses

Outcome(s)

• Primary Outcome: Two year disease-free survival rate
• Secondary Outcome: overall survival, toxicity, completion rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. Inadequate physical condition for gemcitabine or S-1 treatmetn according to manufacture's instruction 2. With pulmonary fibrosis or interstitial pneumonia 3. Massive pleural effusion 4. With distant metastasis 5. Active malignancies other than pancreatic cancer 6. Active infectious disease 7. Severe post operative complications 8. Severe angina, cardiac infurction within 3 months at the registration, and severe hear failure 9. Severe diabetes or hypertension 10. Severe mental disorder 11. Pregnancy, breast feeding, or women who desire to preserve fecundity 12. Inadequate physical condition, as diagnosed by primary physician

Related Information

• Primary Sponsor: Chiba study group of adjuvant chemotherapy for pancreatic cancer
• Source(s) of Monetary Support: none