Multicenter phase I/II trial of adjuvant combination chemotherapy with gemcitabine and S-1 for pancreatic cancer

UMIN ID: UMIN000001038

Registered date:01/04/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 2008/04/01
• Target sample size: 55
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): S1: bid d1-7 q2w x 12 courses PO GEM: d1 q2w x 12 courses DIV The doses of GEM and S-1 in the phase II trial are determined based on the results of the phase I trial.

Outcome(s)

• Primary Outcome: Phase I: the maximum-tolerated dose and dose-limiting toxicity of GS therapy. Phase II: overall survival.
• Secondary Outcome: Phase II: adverse events and disease-free survival.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)Watery diarrhea 2)Severe mental disorder 3)Active infection 4)Severe complications, such as ileus, heart failure and renal failure 5)Symptomatic pulmonary fibrosis or interstitial pneumonia 6)History of radiation therapy to the chest 7)Marked pleural or peritoneal effusion 8)Active concomitant malignancy 9)Treatment with phenytoin, potassium warfarin or flucytosine

Related Information

• Primary Sponsor: Study Group for Adjuvant Chemotherapy of Pancreatic Cancer
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare