First attempt of large phase III oncology trial using Japanese new trial evaluation system, the evaluation system of investigational medical care

Japanese Pharmacology and Therapeutics

Volumn 38, Issue SUPPL. 1, 2010, Pages

  Aotani, Eriko ^a   Kukino, Shinobu ^a   Nonaka, Miwa ^a   Nagao, Shoji ^b   Fujiwara, Keiichi ^b  

^a KITASATO UNIVERSITY   (Japan)

^b SAITAMA MEDICAL UNIVERSITY INTERNATIONAL MEDICAL CENTER   (Japan)

Author keywords

Cancer; Evaluation system of investigational medical care; Intraperitoneal carboplatin; PhaseIII oncology trial; Weekly paclitaxel

Indexed keywords

CARBOPLATIN; PACLITAXEL;

AREA UNDER THE CURVE; ARTICLE; CANCER PATIENT; CLINICAL TRIAL; CONSULTATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ADMINISTRATION ROUTE; DRUG APPROVAL; DRUG COST; DRUG INDUSTRY; DRUG RESEARCH; DRUG SCREENING; FEMALE; HUMAN; JAPAN; JAPANESE; MEDICAL CARE; NATIONAL HEALTH INSURANCE; OVARY CANCER; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PURCHASING; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL; STUDY DESIGN; UTERINE TUBE;

EID: 77955837317     PISSN: 03863603     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (4)

1. http://www.mhlw.go.jp/topics/bukyoku/isei/sensiniryo/kikan02.html
2. Fujiwara K, Nagao S, Kigawa J, et al. Phase II study of intraperitoneal carboplatin with intravenous paclitaxel in patients with suboptimal residual epithelial ovarian or primary peritoneal cancer : a Sankai Gynecology Cancer Study Group Study. Int J Gynecol Cancer 2009 ; 19 : 834-7.
3. Katsumata N, Yasuda M, Takahashi F, et al. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer : a phase 3, open-label, randomised controlled trial. Lancet 2009 ; 374 : 1331-8.
4. http://www.mhlw.go.jp/shingi/2008/03/dl/s0326-8f.pdf