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

NCT02801487 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-02-17

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

RADIATION

Carbon ion radiotherapy (CIRT)

Five dose levels (52.5GyE, 55GyE, 57.5GyE, 60GyE, 62.5GyE) are planned within the Phase I part. Daily fraction of 2.5 GyE will be delivered for all dose levels. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 62.5 GyE are safely delivered, the recommended dose (or 62.5 GyE) will be the prescribed dose in the Phase II part of the study. Ninety-five percent (95%) of the isodose line should cover the GTV+3\~5mm.

DRUG

Cisplatin

Cisplatin (40mg/m\^2) monotherapy will be given weekly along with radiotherapy.

Sponsors & Collaborators

  • Shanghai Proton and Heavy Ion Center

    lead OTHER

Principal Investigators

  • Jiade J Lu, MD · Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-01-01
Completion
2017-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801487 on ClinicalTrials.gov