NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00068

Registered date:31/07/2011

Feasibility study of post-SBRT adjuvant chemotherapy with tegafur-uracil in patients with stage I non-small cell lung cancer

Basic Information

Recruitment status Other
Health condition(s) or Problem(s) studiedStage I Non small cell lung cancer
Date of first enrollment01/09/2011
Target sample size30
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:DRUG. Intervention1:tegafur-uracil, Dose form:CAPSULE, Route of administration:ORAL, intended dose regimen:2 capsules of 200mg BID or 3 capsules of 100mg 3 times a day.

Outcome(s)

Primary Outcomefeasibility. Timepoint:2014/October.
Secondary Outcomesafety, relapse free survival, local relapse free survival, overall survival. Timepoint: 2017/October.

Key inclusion & exclusion criteria

Age minimum>=20 YEARS
Age maximumNo Limit
GenderBOTH
Include criteria1. pathologically or cytologically proved non-small cell lung cancer 2. clinical stage I (T1>=2cm,T2=<4cm) 3. never received thoracic radiation therapy 4. PS 0-2 5. tumor size of >=2cm and =<4cm 6. Being pulmonary tumor 7. Older than 20 years old 8. principal organs have normal function 9. estimated survival more than 6 months 10. considered inoperable or refused operation 11. got informed consent
Exclude criteria1. pulmonary fibrosis found on chest radiography 2. syncronous or metachronous cancer with disease free interval within 5 years 3. had a history of chemotherapy for NSCLC within 5 years 4. indicated progressive disease before administration of UFT 5. under pregnancy 6. had angina, cardiac infarction or heart failure within 3 months with poor control 7. having poor control DM 8. having some infection 9. have fever higher than 38 degrees 10. routine use of steroids

Related Information

Contact

public contact
Name Osamu Suzuki
Address Radiation Oncology,Nakamichi 1-3-3, Higashinari, Osaka City
Telephone +81-6-6972-1181
E-mail osamu-s@umin.ac.jp
Affiliation Osaka Medical Center for Cancer and Cardiovascular Diseases
scientific contact
Name Osamu Suzuki
Address Radiation Oncology,Nakamichi 1-3-3, Higashinari, Osaka City
Telephone +81-6-6972-1181
E-mail
Affiliation Osaka Medical Center for Cancer and Cardiovascular Diseases