Phase II study of Gemcitabine plus alternate-day administrations of S-1 in patients with unresectable advanced pancreatic cancer. - Phase II study of GEM + alternate-day S-1 treatment for pancreatic cancer.

Fukushima medical University Hospital, School of medicine0 个研究点目标入组 30 人开始时间: 2013年2月21日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•(1) Contraindication of Gemsitabine and S-1. (2) Pulmonary fibrosis or interstitial pneumonia (to be confirmed by chest X-ray within 28 days before registration). (3)Watery diarrhea. (4)Active infections (e.g. patients with pyrexia of 38 degree centigrade or greater), excluding viral hepatitis. (5)Serious complications (e.g. heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes). (6)Moderate or severe (requiring drainage) ascites or pleural effusion requiring treatment. (7) Metastasis in the CNS. (8) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 3 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration. (9) Current use of flucytosine, phenytoin or warfarin potassium. (10) For female subject: Positive Pregnancy test, presently breast feeding or unwilling to use effective contraceptive measure. For male subjects: intent to procreate during the duration of the study or unwilling to use effective contraceptive measure. (11) Severe mental disorder. (12) Severe drug allergies. (13)Decision of not eligible determined by principle investigator or attending doctor.

发起方

Fukushima medical University Hospital, School of medicine