A Randomized Clinical Trial of High-Dose Chemotherapy with Autologous Peripheral Blood Stem Cell Transplantation in Limited-Disease Small-Cell Lung Cancer.

Authors
Category Primary study
JournalUMIN Clinical Trials Registry
Year 2005
INTERVENTION: Cisplatin + etoposide with conccrent accelerated hyperfractionated thoracic radiation therapy followed by high‐dose chemotherapy (ifosfamide/carboplatin/etoposide) with autologous peripheral blood stem cell transplantation Cisplatin + etoposide with conccrent accelerated hyperfractionated thoracic radiation therapy CONDITION: Small‐cell lung cacer, limited disease PRIMARY OUTCOME: 5‐year disease free survival INCLUSION CRITERIA: 1. Histologically or cytologically documented SCLC 2. No prior therapy 3. 65 years old or less 4. Performance status (ECOG) of 0 ‐ 2 5. Normal hematologic function: WBC>=4000/microml, PLT>=100,000/microml 6. Normal hepatic function: T‐Bil=<1.5 mg/dl, AST, ALT=<2.5 x normal 7. Normal renal function: Creatinine=<1.5 mg/ml, Ccr=<60 ml/min 8. Normal pulmonary function: PaO2=<60 Torr, %DLco>=60% 9. Normal cardiac function: Ejection fraction=>60% 10. Written informed consent Eligibility Criteria for High‐Dose Chemotherapy 1. Responders to the induction chemotherapy: CR or PR 2. Performance status (ECOG) of 0 ‐ 1 3. Normal hematologic, hepatic, renal, pulmonary and cardiac functions 4. PBSCs CD34 positive cells=>1x10^6/kg
Epistemonikos ID: 0cb206cf3b3d1e46481748525a16bd12055ec079
First added on: Aug 21, 2024