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Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Phase I/II Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma

Clinical Trial Summary

The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) along with concurrent chemotherapy in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens along with concurrent chemotherapy (40 mg/m^2, weekly) to evaluate the maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and within 4 months after the completion of concurrent chemoradiotherapy. Once the MTD for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.

Clinical Trial Description

The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) along with concurrent chemotherapy in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD in the setting of concurrent chemoradiotherapy. Participants will be treated with CIRT with escalating dose starting from 52.5GyE (2.5GyE/daily fraction) to potentially 62.5GyE (2.5GyE/daily fraction) along with concurrent chemotherapy (40 mg/m^2, weekly) to evaluate the maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and within 4 months after the completion of concurrent chemoradiotherapy. Time-to-event continual reassessment method (TITE-CRM) is used for the phase I dose escalating part of the trial and approximately 25 patients will be accrued. Once the MTD in the setting of concurrent chemoradiotherapy for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial. The Phase II part of the trial will be a single phase single arm study. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02795169
Study type Interventional
Source Shanghai Proton and Heavy Ion Center
Contact Lin Kong, MD
Email lin.kong@sphic.org.cn
Status Recruiting
Phase Phase 1/Phase 2
Start date September 2015
Completion date March 2021
View Details
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