NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Pancreatic cancer
Date of first enrollment	15/07/2011
Target sample size	140
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : S-1(tegafur + gimeracil + oteracil potassium), LV(Levofolinate calcium) INN of investigational material : S-1:tegafur, gimeracil, oteracil potassium, LV:folic acid Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 40-60 mg of S-1 and 25 mg of LV was administered orally twice daily for 7 days with a rest period of 7 days as one course. control material(s) Generic name etc : S-1(tegafur + gimeracil + oteracil potassium) INN of investigational material : S-1:tegafur, gimeracil, oteracil potassium Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 40-60 mg of S-1 was administered orally at twice daily for 28 days with a rest period of 14 days as one course.

Outcome(s)

Primary Outcome	Progression free survival(PFS) To compare the progression free survival (defined as the time from treatment to disease progression or death due to any cause) for S-1 puls LV versus S-1 alone.
Secondary Outcome	Efficacy, Safety

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 79age old
Gender	Both
Include criteria	- Patients must be diagnosed as invasive pancreatic ductal carcinoma - Patients with gemcitabine-refractory - Age: 20 years to 79 years - Eastern Cooperetive Oncology Group (ECOG) performance status (PS) of 0 or 1 - Sufficient oral intake - Written informed consent
Exclude criteria	- Diarrhea - History or presence of severe pulmonary disease - History or presence of severe heart disease - Uncontrolled or severe diabetes - Severe complications(e.g., severe enteritis, severe stomatitis, gastrointestinal ulcer)