NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001038

Registered date:01/04/2008

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

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedpancreatic cancer
Date of first enrollment2008/04/01
Target sample size55
Countries of recruitmentJapan
Study typeInterventional
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 OutcomePhase I: the maximum-tolerated dose and dose-limiting toxicity of GS therapy. Phase II: overall survival.
Secondary OutcomePhase II: adverse events and disease-free survival.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria1)Histologically proven pancreatic adenocarcinoma 2)Gross complete resection (R0 or R1) 3)No prior chemotherapy or radiotherapy 4)Age between 20 and 79 years 5)ECOG performance status of 0 or 1 6)Adequate hematologic, hepatic and renal function 7)Written informed consent
Exclude criteria1)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

Contact

public contact
Name Tomoo Kosuge
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo Japan
Telephone 03-3542-2511
E-mail tkosuge@ncc.go.jp
Affiliation Office of the Study Group for Adjuvant Chemotherapy of Pancreatic Cancer National Cancer Center Hospital, HBP Surgery Division
scientific contact
Name Tomoo Kosuge
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo Japan
Telephone 03-3542-2511
E-mail tkosuge@ncc.go.jp
Affiliation National Cancer Center Hospital HBP Surgery Division