drugset / Trial / NCT02801487

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

NCT02801487 ↗

Phase 1/2 Terminated 6 enrolled Shanghai Proton and Heavy Ion Center
NaSingle-groupOpen-labelTreatment

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 subacute 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.

Timeline

Start
2015-09
Primary completion
2017-01-01
Completion
2017-01

Outcome

Outcome not reported

Stopped (Enrollment): “Slow accrual of patients.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 40 mg/m2 —