Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP)

Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP) - Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005342

Enrollment

Registered

2011-03-30

Start date

2011-03-30

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 disease small cell lung cancer

Interventions

A: etoposide 100mg/m2 days 1-3, cisplatin 80mg/m2 day 1, and thoracic radiotherapy 45Gy/30 fractions, followed by three cycles of cisplatin 25mg/m2 days 1, 8, vincristine 1mg/m2 day 8, doxorubicin 40m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) a histological or cytological diagnosis of small cell lung cancer 2) limited disease and clinical stage II-III 3) age between 20 and 70 years old 4) ECOG performance status of 0-1 5) having a measurable disease 6) the first treatment for small cell lung cancer 7) no prior chemothearpy or thoracic radiotherapy for any malignancies 8) a radiation oncologist determines that radiothearpy is possible 9 ) adequate organ functions defined as indicated below; i) WBC of 4,000/mm3 or more ii) Hemoglobin of 9.0 g/dL or more iii) Platelet of 100,000/mm3 or more iv) Total serum bilirubin of 1.5 mg/dL or less v) GOT (AST) of 100 IU/L or less vi) GPT (ALT) of 100 IU/L or less vii) Serum creatinine of 1.3 mg/dL or less viii) PaO2 of 70 torr or more at room air 10) written informed consent

Exclusion criteria

Exclusion criteria: 1) synchronous or metachronous active malignancies 2) allergy to a contrast agent 3) any of the followings: i) inappropriate secretion of antidiuretic hormone (SIADH) ii) ectopic ACTH syndrome iii) Lambert-Eaton myasthenic syndrome iv) subacute cerebellar degeneration v) paraneoplastic encephalomyelitis / sensory neuropathy 4) infection requiring systemic treatment 5) fever of 38 degrees centigrade or higher within 24 hours before registration 6) pregnant or lactating women 7) psychotic disorder 8) receiving systemic steroid therapy 9) unstable angina or myocardial infarction within the past 6 months 10) uncontrolled hypertension 11) uncontrolled diabetes mellitus or administration of insulin 12) interstitial pneumonitis or lung fibrosis identified by a chest X-ray, or severe pulmonary emphysema

Design outcomes

Primary

Measure	Time frame
Progression-free survival rate at one-year from 2nd registration	—

Secondary

Measure	Time frame
Response rate, complete response rate, overall survival , progression-free survival , and incidences of adverse event, grade 4 non-hematological toxicit, early death, and treatment-related death	—

Countries

Japan

Contacts

Public ContactIkuo Sekine

JCOG1011 Coordinating Office Division of Thoracic Oncology, National Cancer Center Hospital

JCOG_sir@ml.jcog.jp03-3542-2511

Outcome results

None listed

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