A phase I trial of definitive chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) for advanced esophageal carcinoma: Kitasato digestive disease & oncology group trial (KDOG 0501)

Background and purposeA dose-escalation study of docetaxel combined with cisplatin, 5-fluorouracil, and concurrent radiotherapy (DCF-R) was performed to determine the optimal dose in patients with advanced esophageal carcinoma.Patients and methodsA total of 19 patients who had previously untreated thoracic esophageal carcinoma with T4 tumors and/or M1 lymph-node metastasis were studied. The Patients received an infusion of docetaxel (levels 1, 2, 3, 2.5: 20, 30, 40, 35 mg/m2) and an infusion of cisplatin (40 mg/m2) on days 1, 15, 29, and 43 plus a continuous infusion of 5-fluorouracil (400 mg/m2/day) on days 1–5, 15–19, 29–33, and 43–47. And patients received 61.2 Gy/34 fractions/7 weeks of concurrent radiotherapy.ResultsDose-limiting toxicities (DLTs) were febrile neutropenia and grade 4 leukopenia lasting 3 days. DLT occurred in 2 of 6 patients at level 2, 3 of 4 patients at level 3, and 2 of 6 patients at level 2.5. The main toxicities were myelotoxicity and esophagitis. The overall response rate was 89.5%, including a complete response rate of 42.1%.ConclusionsThe maximum-tolerated dose was level 3, because 50% or more of the patients had DLTs. Therefore, level 2.5 was recommended for phase II studies. This regimen was tolerable and highly active.