7064 Background: EBMT has defined in a phase II trial (JCO 1999, 3531) feasibility and activity of high-dose sequential CT for SCLC increasing 3 fold the dose-intensity and significantly the peak-dose and the total dose of CT. Methods: Randomized prospective study aiming to improve the 3-year survival from 12% in the standard (S) to 24% in the high-dose (H) arm, for a total accrual of 340 patients. Limited or extensive ≤ 2 metastatic sites, age ≤ 65 y.o., PS 0–1. Arm S/Arm H: ifosfamide 5 g/m2 d1/2.5 g/m2/d × 4; carboplatin 300 mg/m2 d1/AUC = 5/d × 4; etoposide 180 mg/m2/d. × 2/300 mg/m2/d × 4, every 28 days, for 6 cycles in Arm S. Three cycles were given in Arm H supported by PBPC collected after 2 courses of epirubicin 150 mg/m2/paclitaxel 175 mg/m2. Due to low accrual, a formal stopping rule was introduced with boundaries for early stopping in favour of a difference (O’Brien-Fleming) or of lack thereof (Pocock). The present analysis has been done with 110 deaths. Results: Since June 1997, 145 patients have been accrued (evaluable =140, S = 71, H = 69), median age 53, prognostic factors balanced. Mobilization toxicity ≥ 3: neutropenia 61%, thrombopenia 11%, anemia 7%, infection 6%, mucositis 9% and 2 toxic deaths. Toxicity ≥ 3 among 353 cycles of S and 152 of H respectively: neutropenia 26%/100%, thrombopenia 12%/100%, anemia 8%/69%, infection 1%/15%, fever 11%/72%, toxic death 1/8. Response rate of S and H: 67% (CR 32%)/77% (CR 37%) (p = 0.188). Median follow-up 4.9 years. Progression free survival 8.8 and 12 months (p = 0.737, unadjusted) and median overall survival 15 and 19.1 months (p = 0.659, unadjusted) for S and H respectively. At 3 years, 19% of the patients were alive in both arms. Conclusions: Random-ICE was designed with strong statistical power and shows no evidence that the treatment of SCLC can be improved by increasing the dose-intensity, the peak-dose or the total dose of ICE and that such intensification strategy should probably be abandoned. No significant financial relationships to disclose.