The aim of the study is to determine the maximum tolerated dose (MTD) and acute dose-limiting toxicities (DLTs) of adjuvant concurrent paclitaxel and cisplatin (TP) with pelvic intensity-modulated radiotherapy (IMRT) for early-stage cervical cancer patients with high risk factors. Women who underwent radical hysterectomy and pelvic lymphadenectomy for stages IB-IIA cervical cancer and had high risk factors were enrolled. One cycle of TP was delivered before and after concurrent chemoradiotherapy, respectively. Then 3 weeks after the start of the initial cycle of the chemotherapy, patients received IMRT in a total dose of 50-50.4 Gy in 25-28 fractions with two cycles of concurrent TP, which was administered with escalating doses. Eighteen patients were enrolled at three dose levels. At dose level 1 (paclitaxel 90 mg/m(2), cisplatin 40 mg/m(2)) and level 2 (paclitaxel 90 mg/m(2), cisplatin 50 mg/m(2)), DLT (grade 3 leukopenia) was observed in one patient, respectively. At level 3 (paclitaxel 105 mg/m(2), cisplatin 50 mg/m(2)), two DLTs (grade 3 leukopenia) were observed in two patients. The MTD of paclitaxel and cisplatin was then defined as 90 and 50 mg/m(2), respectively. Pelvic IMRT and concurrent TP is a safe and tolerable adjuvant treatment regimen for cervical cancer patients with high risk factors. The MTD of concurrent chemotherapy is paclitaxel 90 mg/m(2) and cisplatin 50 mg/m(2). Trial registration Current controlled trials ChiECRCT-2014025.
Keywords: Cervical cancer; Cisplatin; IMRT; Paclitaxel; Phase I study.