Phase I/II trial of carboplatin plus CPT-11 chemotherapy with accelerated hyperfractionated radiotherapy for elderly patients with limited stage small cell lung cancer (TORG0604).

Phase I/II trial of carboplatin plus CPT-11 chemotherapy with accelerated hyperfractionated radiotherapy for elderly patients with limited stage small cell lung cancer (TORG0604). - Phase I/II trial of carboplatin plus CPT-11 chemotherapy with accelerated hyperfractionated radiotherapy for elderly patients with limited stage small cell lung cancer (TORG0604).

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007352

Enrollment

Registered

2012-02-23

Start date

2006-12-01

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

limited stage small cell lung cancer

Interventions

carboplatin plus CPT-11 chemotherapy with accelerated hyperfractionated chestradiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) histopathologically or cytologically confirmed small cell lung cancer 2) 70 years old or more 3) limited stage small cell lung cancer 4) no prior radiotherapy or chemotherapy for the small cell lung cancer 5) Eastern Cooperative Oncology Group Performance Status:0-2 6) measurable disease 7) no other active malignancy 8) adequate organ functions: WBC> 3000/mm3, absolute neutrophil count> 1500/mm3, platelet count> 100000/mm3, hemoglobin> 9g/dL, AST< 2.5*the upper limit of normal(ULN), ALT< 2.5*ULN, bilirubin> 2.0mg/dL, serum creatinine< 1.5mg/dL, creatinine clearance> 40mL/min, PaO2> 70Torr 9) appropriate informed consent form has confirmed before registration

Exclusion criteria

Exclusion criteria: 1) other active malignancy 2) active infection 3) obviously proven interstitial lund disease by x-ray 4) myocardiac infarction within six monthes before registration 5) uncontrollable heart diseases or hepatic diseeases or diabates or hemorrhage 6) severe mental disorder 7) diarrhea or watery stool 8) massive pleural effusion (more than one centimeter thickness of chest CT scan) 9) ileus

Design outcomes

Primary

Measure	Time frame
Phase I: recommended dose Phase II:toxicity profiles, response rate, feasibility	—

Secondary

Measure	Time frame
overall survival progression free survival	—

Countries

Japan

Contacts

Public ContactYuki Misumi

Yokohama Municipal Citizens' Hospital Department of respilatory medicine

045-331-1961

Outcome results

None listed

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