drugset / Trial / NCT01854203

Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC

NCT01854203

Phase 2/3 Unknown 300 enrolled Sun Yat-sen University
RandomizedParallel-groupSingle-blindTreatment

Summary

Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.

Timeline

Start
2013-07
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 30 mg/m2
Subject Cisplatin Other / unclassified 80 mg/m2
Background Gemcitabine Small molecule 800 mg/m2