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Clinical Trial Summary

The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) 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 maximal tolerated dose (MTD) in terms of acute and subactue 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) 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 55GyE (2.5GyE/daily fraction) to potentially 65GyE (2.5GyE/daily fraction) to evaluate the maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and within 4 months after the completion of CIRT. 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 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


NCT number NCT02569788
Study type Interventional
Source Shanghai Proton and Heavy Ion Center
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date September 2015
Completion date May 1, 2017

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