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Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Phase I/II Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) 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) with the fraction size of 3 gray equivalent (GyE) 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 to evaluate the MTD in terms of acute and subacute toxicity observed during and within 4 months after the completion of CIRT. 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) with the fraction size of 3 GyE 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 starting from 54GyE (3GyE/daily fraction) to potentially 63GyE (3GyE/daily fraction) to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 4 months after the completion of CIRT. The classic 3+3 method is used for the phase I dose escalating part of the trial and approximately 4-18 patients will be accrued. 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. The Phase II part of the trial will be a single phase single arm study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02795195
Study type Interventional
Source Shanghai Proton and Heavy Ion Center
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date January 2016
Completion date December 2020
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