NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000608

Registered date:01/04/2007

Phase III randomized comparative study of combination therapy with CDDP and TS-1 vs. combination therapy with CDDP and Docetaxel in stage IIIB/IV non-small cell lung cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedStage IIIB/IV or ppstoperative recurrent non-small sell lung cancer
Date of first enrollment2007/04/01
Target sample size600
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)CDDP: 80mg/m2 day1 Docetaxel: 60mg/m2 day1 q3-4weeks Doc(60mg/m2) day8 TS-1(800mg/m2) day1-21 q4-5weeks

Outcome(s)

Primary Outcomeoverall survival
Secondary OutcomePFS TTF Response rate Adverse event QOL

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria1.Histologically or cytologically confirmed NSCLC 2.Oral intake is possible 3.Stage IIIB or IV and recurrence after operation 4.With measurable or assessable legion(s) 5.Age of 20 to 74-year old 6.PS(ECOG)0 or 1 7.Without prior anti-tumor therapy 8.Preserved organ functions 8.Adequate bone marrow,hepatic and renal function 9.Written IC 10.Life expectancy longer than 12 weeks
Exclude criteria1.With adjuvant chemotherapy 2.History of serious drug allergy 3.Active concomitant malignancy 4.Serious complications 5.Proven or suspected infections diseases 6.Symptomatic brain metastasis 7.Watery diarrhea or Chronic constipation 8.Pleural effusion,peritoneal fluid,and pericardial fluid 9.Concomitant therapy with another anticancer drug or flucytocine 10.Pregnancy,breast feeding or wish of future bearing 11.Mental disease or psychotic manifestation 12.It participated in the development clinical trial of and others within 1 month 13.Other conditions not suitable for this study

Related Information

Contact

public contact
Name
Address Japan
Telephone
E-mail
Affiliation The Tokyo cooperative oncology group Clinical Study Promotion Agency
scientific contact
Name Shoji Kudo
Address 3-1-24 Matsuyama Kiyose-City Tokyo,Japan Japan
Telephone
E-mail
Affiliation Fukujuji Hospital Director