NIPH Clinical Trials Search

UMIN ID: UMIN000002162

Registered date:03/07/2009

A Phase I Study of Concurrent Chemotherapy using TS-1 with Involved Field Radiotherapy for Elderly Patients with Non-Small Cell Lung Cancer.

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedNon-Small Cell Lung Cancer
Date of first enrollment2009/04/01
Target sample size18
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Radiation: using 6-10MV X-ray, daily 2Gy, 5 days/week until 64Gy. TS-1: TS-1 (each level) is administered orally on days 1-14 every 21 days.


Primary OutcomeTo determine maximum tolerated dose and recommended dose of TS-1+RT for elderly patients of Non-small cell lung cancer.
Secondary OutcomeAdverse events for treatment (56days) or after 56days, Response rate (RR), Overall survival (OS), Disease control rate, Disease free survival (DFS)

Key inclusion & exclusion criteria

Age minimum75years-old
Age maximum89years-old
GenderMale and Female
Include criteria
Exclude criteria1 patient with marked fever and suspected infection 2 patient has dreaded complication 3 concomittant active malignancy 4 needing teratment pleulal effusion and hydroperitoneum syndrome 5 patient of the pericardium water retension syndrome 6 patient has chicken pox 7 Serious neuropathy 8 Anarmnesis of drug allergy 9 Severe bone marrow suppression 10 serious renal function disturbance 11 serious liver function disturbance 12 taking other fluoropyrimidime 13 Under treatment with flucytosine 14 Not suitable for participating in the study for any othe reason

Related Information


public contact
Address Japan
Telephone 082-257-1545
Affiliation Hiroshima university Department of Radiology
scientific contact
Name Yasushi Nagata
Address 1-2-3,kasumi, minami-ku, Hiroshima-shi, Hiroshima 730-8551, Japan Japan
Affiliation Hiroshima university Department of Radiology