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

JRCT ID: jRCTs031180193

Registered date:06/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Elderly patients with extended-stage small-cell lung cancer
• Date of first enrollment: 03/02/2014
• Target sample size: 256
• Study type: Interventional
• 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 Outcome: Phase III: Overall survival, Phase II: Response rate of CI arm

Secondary Outcome

Phase 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 maximum: Not applicable
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: OKAMOTO Hiroaki
• Source(s) of Monetary Support: National Cancer Center Japan,Ministry of Health, Labour and Welfare,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000012605