NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180193

Registered date:06/03/2019

JCOG1201/TORG1528: A Phase II/III Study Comparing Carboplatin and Irinotecan (CI) with Carboplatin and Etoposide (CE) for the Treatment of Elderly Extended-Stage Small-Cell Lung Cancer

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedElderly patients with extended-stage small-cell lung cancer
Date of first enrollment03/02/2014
Target sample size256
Countries of recruitment
Study typeInterventional
Intervention(s)Arm A:CBDCA+ETP(Every 3 weeks X 4 courses),CBDCA:AUC 5,day 1 ETP:80 mg/m2,day 1-3 Arm B:CBDCA+irinotecan(Every 3 weeks X 4 courses),CBDCA:AUC 4,day 1 irinotecan:50mg/m2,day 1,8

Outcome(s)

Primary OutcomePhase III: Overall survival, Phase II: Response rate of CI arm
Secondary OutcomePhase III: Progression-free survival, Response rate, Adverse events, Serious adverse events, Symptom score Phase II: Adverse events

Key inclusion & exclusion criteria

Age minimum>= 71age old
Age maximumNot applicable
GenderBoth
Include criteria1) Histologically or cytologically confirmed small-cell lung cancer 2) Extended-disease 3) No serious tumor related complications 4) 71 years of age or older 5) ECOG performance status of 0 to 2 6) With measurable lesions 7) No prior surgery, radiotherapy, or chemotherapy for small-cell lung cancer 8) No prior thoracic radiotherapy or chemotherapy for any other cancers within a year of enrollment 9) Adequate organ functions 10) No diarrhea, intestinal obstruction or past history of intestinal obstruction 11) Written informed consent
Exclude criteria1) Synchronous or metachronous (within 1 years) malignancies 2) Active infection requiring systemic therapy 3) Body temperature >= 38 degrees Celsius 4) Psychiatric disease 5) Patients requiring systemic steroid medication (>= 5 mg/day of prednisolone) 6) Poorly controlled diabetes mellitus (HbAic >= 8.0%) 7) Poorly controlled hypertension 8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months 9) Interstitial pneumonia or pulmonary fibrosis

Related Information

Contact

Public contact
Name Tsuneo SHIMOKAWA
Address 1-1 Mitsuzawanishimachi,Kanagawa-ku,Yokohama-shi,Kanagawa ,221-0855 Japan Kanagawa Japan 221-0855
Telephone +81-45-316-4580
E-mail ts00-shimokawa@city.yokohama.jp
Affiliation Yokohama Municipal Citizen's Hospital
Scientific contact
Name Hiroaki OKAMOTO
Address 1-1 Mitsuzawanishimachi,Kanagawa-ku,Yokohama-shi,Kanagawa ,221-0855 Japan Kanagawa Japan 221-0855
Telephone +81-45-316-4580
E-mail hi01-okamoto@city.yokohama.jp
Affiliation Yokohama Municipal Citizen's Hospital