NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001424

Registered date:10/10/2008

Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0803/WJOG4307L)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiednon-small-cell lung cancer
Date of first enrollment2008/10/01
Target sample size380
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A : 3-weekly docetaxel alone B : Weekly docetaxel+cisplatin combination

Outcome(s)

Primary Outcomeoverall survival
Secondary Outcomeadverse events, progression-free survival, response rate, complete response rate, Symptom Score

Key inclusion & exclusion criteria

Age minimum70years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) Symptomatic brain metastasis 2) Active another neoplams 3) Severe SVC syndrome 4) Massive pericardial, pleural effusion, or ascites 5) Bone metastasis emergent for palliative radiotherapy or surgery 6) Uncontrollable systemic hypertension 7) Heart failure, Unstable angina, Myocardial infarction within 6 months 8) Uncontrollable diabetes 9) Active infection other than viral hepatitis 10) Hepatitis B virus infection 11) Interstitial pneumonia/ Pulmonary fibrosis 12) Hypersensitivity for polysolbate 80 13) Systemic administartion of corticosteroids

Related Information

Contact

public contact
Name Teduya Abe
Address 2-15-3, Kawagishi-cho, Chuo-ku, Niigata, Niigata 951-8566, JAPAN Japan
Telephone 025-266-5111
E-mail JCOG_sir@ml.jcog.jp
Affiliation JCOG0803/WJOG4307L Coordinating Office Department of internal medicine, Niigata Cancer Center Hospital
scientific contact
Name Akira Yokoyama
Address 2-15-3, Kawagishi-cho, Chuo-ku, Niigata, Niigata 951-8566, JAPAN Japan
Telephone 025-266-5111
E-mail
Affiliation Niigata Cancer Center Hospital Department of internal medicine