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 (Elderly ED-SCLC/CI vs. CE)

Completed

• Conditions: Elderly patients with extended-stage small-cell lung cancer

• Registration Number: jRCTs031180193

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-03
• Study First Submitted: 2019-03-06
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 256

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Phase III: Overall survival, Phase II: Response rate of CI arm