Hypofractionated Versus Conventionally Fractionated Radiotherapy for Initial Distant Metastases Nasopharyngeal Carcinoma

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
PRIMARY OBJECTIVES: I. To determine if hypofractionated with a smaller total dose radiation is not inferior to standard‐dose radiation in progression‐free survival for initial distant metastases nasopharyngeal carcinoma . SECONDARY OBJECTIVES: I. To evaluate if hypofractionated with a low total dose radiation is not inferior to standard‐dose radiation in overall survival and locoregional failure‐free survival for initial distant metastases nasopharyngeal carcinoma II. To evaluate if hypofractionated with a low total dose radiation with chemotherapy decrease treatment‐related toxicities OUTLINE: Patients are randomized to one of the two treatment arms ARM 1: Patients receive hypofractionated with a low total dose radiation with induced chemotherapy and adjuvant chemotherapy.Hypofractionated dose IMRT: GTVnx 60Gy, GTVnd 60Gy, PTV1 50Gy and PTV2 45Gy in 25 fractions, 5 days/week. Induced chemotherapy: Paclitaxel 135mg/m2 D1+Cisplatin 75mg/m2 D1(or D1‐3), 3‐week chemotherapy for 3 cycles. After radiation, patients receive adjuvant chemotherapy Paclitaxel 135mg/m2 D1+Cisplatin 75mg/m2 D1(or D1‐3), 3‐week chemotherapy for 3 cycles. ARM 2: Patients receive standard‐dose radiation with concurrent chemotherapy. Standard‐dose IMRT: GTVnx 69.69Gy, GTVnd 60‐68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week. Induced chemotherapy: Paclitaxel 135mg/m2 D1+Cisplatin 75mg/m2 D1(or D1‐3), 3‐week chemotherapy for 3 cycles. After radiation, patients receive adjuvant chemotherapy Paclitaxel 135mg/m2 D1+Cisplatin 75mg/m2 D1(or D1‐3), 3‐week chemotherapy for 3 cycles. After completion of study therapy, patients are followed up every 3‐4 months for 2 years, then every 6 months for 3 years.
Epistemonikos ID: 8698dad1027bfb0815eb8934ccd4e5a3cc9f3587
First added on: May 21, 2024