Spots Global Cancer Trial Database for Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With IMRT in High Risk Nasopharyngeal Carcinoma

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Trial Identification

Brief Title: Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With IMRT in High Risk Nasopharyngeal Carcinoma

Official Title: Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With Intensity-modulated Radiotherapy in High Risk Locregionally Advanced Nasopharyngeal Carcinoma: a Phase 2 Randomized Controlled Trial

Study ID: NCT02610556

Conditions

Nasopharyngeal Carcinoma

Interventions

Cisplatin 2

Docetaxel

Cisplatin 1

Intensity-modulated radiotherapy

Study Description

Brief Summary: The investigators aim to evaluate the efficiency and toxicities of concurrent docetaxel and cisplatin with intensity-modulated radiotherapy in high risk locoregionally advanced nasopharyngeal carcinoma.

Detailed Description: Eligible patients are randomly assigned to receive intensity-modulated radiotherapy (IMRT) with concurrent chemotherapy of docetaxel plus cisplatin or cisplatin alone. IMRT is delivered with a total dose of 68 Gy or higher in 33 fractions to the primary tumor. Concurrent chemotherapy in the experimental arm consists of docetaxel 60 mg/m², D1 and cisplatin 25 mg/m², D1-3 every 3 weeks for 3 cycles. Concurrent chemotherapy in the control arm consists of cisplatin 100 mg/m², D1 every 3 weeks for 3 cycles.The primary endpoint is overall survival (OS), defined as time from randomization to the day of death from any cause. Secondary end points include failure-free survival (FFS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS) and the incidence of grade 3 or higher acute toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.