A phase I/II NCCTG trial of escalating doses of twice daily thoracic radiation therapy (TRT) in limited-stage small cell lung cancer (LSCLC)

7163 Background: The primary goal of the phase I portion of this trial was to identify the maximum tolerable dose(MTD) of TRT that can be given concurrently with etoposide(E), cisplatin(P), and amifostine for LSCLC patients(pts). Methods: Pts eligible for this study included those with LSCLC, ECOG performance scores 0–2, adequate pulmonary and laboratory functions who were able to provide informed consent. The treatment regimen consisted of 2 cycles of topotecan(1mg/m2) days 1–5 and paclitaxel(175 mg/m2) day 5 (q 3 weeks). TRT was required to begin at 6 weeks. The TRT was given in 120 cGy fractions BID and the dose escalation followed the cohorts of 3 design (see table below). The E(50mg/day) and P(3mg/m2) were given before the morning and amifostine(200mg/m2) was given before the afternoon radiation fractions. This was followed by 2 more cycles of topotecan + paclitaxel, and then PCI. The dose-limiting toxicities(DLTs) were defined as >grade 4 hematologic(for >5 days), febrile neutropenia, esophagitis or...