drugset / Trial / NCT02289807

Concurrent Chemotherapy in Intermediate Risk Patients Treated With Intensity-modulated Radiotherapy

NCT02289807

RandomizedParallel-groupOpen-labelTreatment

Summary

Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National Comprehensive Cancer Network guideline. However these recommendations were based on the evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better treatment outcomes than 2DCRT. It has been questioned whether additional concurrent chemotherapy is still necessary for intermediate risk NPC within the excellent framework of IMRT. hus, we jointly conduct the first non-inferior randomized trial to determine the value of concurrent chemotherapy with cisplatin for intermediate risk NPC patients treated with IMRT. Given the results of clinical studies mentioned above, we decide to adopt the concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22, 43

Timeline

Start
2015-03
Primary completion
2020-08
Completion
2022-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 100 mg/m2