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 (JCOG1201/TORG1528, Elderly ED-SCLC/CI vs. CE)

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 (JCOG1201/TORG1528, Elderly ED-SCLC/CI vs. CE) - 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 (JCOG1201/TORG1528, Elderly ED-SCLC/CI vs. CE)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012605

Enrollment

370

Registered

2013-12-17

Start date

2013-12-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly patients with extended-stage small-cell lung cancer

Interventions

A: 4 courses of chemotherapy with carboplatin (AUC 5, day 1) and etoposide (80 mg/m2/day, day 1-3) repeated every 3 weeks B: 4 courses of chemotherapy with carboplatin (AUC 4, day 1) and irinotecan (5

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Phase III: Overall survival, Phase II: Response rate of CI arm	—

Secondary

Measure	Time frame
Phase III: Progression-free survival, Response rate, Adverse events, Serious adverse events, Symptom score Phase II: Adverse events	—

Countries

Japan

Contacts

Public ContactTsuneo Shimokawa, Yuki Misumi

JCOG1201/TORG1528 Coordinating Office Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital

JCOG_sir@ml.jcog.jp045-331-1961

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026