Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 58
Summary
- Conditions
- Nasopharyngeal Carcinoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT02795195
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jiade J Lu, MD Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
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