drugset / Trial / NCT02434614

Induction Chemotherapy Followed by IMRT With or Without Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

NCT02434614 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC). Based on these evidences, concurrent chemoradiotherapy (CCRT) with/without sequential chemotherapy has become the standard care for locoregionally advanced NPC. However, most of these evidences of standard treatment for locoregionally advanced NPC were based on the two-dimensional conventional radiotherapy (2DCRT). As the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, more retrospective studies compared the IMRT alone vs. IMRT plus concurrent chemotherapy, and reported that concurrent chemotherapy failed to improve survival rates for patients with locoregionally advanced disease, but increased the severity of acute toxicities. People started to reconsider the role of CCRT. Therefore, we propose this randomized phase III non-inferiority study to reassess the efficacy and contribution of concurrent chemotherapy in locoregionally advanced NPC during IMRT era.

Timeline

Start
2015-03
Primary completion
2021-05
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 30 mg/m2 Intravenous
Comparator Cisplatin Other / unclassified 60 mg/m2 Intravenous
Background Docetaxel Small molecule 60 mg/m2 Intravenous
Background fluorouracil Small molecule 600 mg/m2 Intravenous