NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000060

Registered date:15/08/2005

Randomized Controlled Trial to Evaluate Standard Thoracic Radiotherapy With or Without Concurrent Daily Low-dose Carboplatine in Elderly Patients with Locally Advanced Non-small Cell Lung Cancer(JCOG0301, NCSLC-Elderly-CBDCA-RT Phase III)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedNon-small cell Lung Cancer
Date of first enrollment2003/09/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Radiotherapy alone CBDCA and Radiotherapy

Outcome(s)

Primary Outcomeoverall survival
Secondary OutcomeResponse rate, Adverse events, Progression-free survival, Pattern of progression/relapse

Key inclusion & exclusion criteria

Age minimum71years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria(1) active infection, diarrhea, ileus, uncontrolled diabetes, myocardial infarction within three months, severe other comorbity, (2) synchronous cancer or metachronous (within 5 years) malignancy, (3) interstitial pneumonia or active lung fibrosis on chest X-ray, (4) severe chronic obstructive pulmonary disease, chronic bronchitis, bronchial asthma, (5) pleural or pericardial effusion, (6) a history of severe hypersensitivity, (7) mental disorder, (8) judging of inappropriate condition for this study by physician.

Related Information

Contact

public contact
Name Shinji Atagi, MD
Address 1180 Nagasone, Sakai, Osaka, 591-8555, Japan Japan
Telephone 072-252-3021
E-mail JCOG_sir@ml.jcog.jp
Affiliation JCOG0301 Coordinating Office Department of Internal Medicine, Kinki-Chuo Chest Medical Center
scientific contact
Name Shinji Atagi, MD
Address 1180 Nagasone, Sakai, Osaka, 591-8555, Japan Japan
Telephone
E-mail
Affiliation Kinki-Chuo Chest Medical Center Department of Internal Medicine