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

Last updated: June 6, 2016
Sponsor: Shanghai Proton and Heavy Ion Center
Overall Status: Active - Recruiting

Phase

1/2

Condition

Carcinoma

Nasopharyngeal Cancer

Treatment

N/A

Clinical Study ID

NCT02795169
SPHIC-TR-HNCNS-2015-02
  • Ages 18-70
  • Both

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 subactue 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pathologically confirmed NPC

  • Completed a definitive course of intensity-modulated photon radiation therapy (IMXT)to a total dose of ≥ 66 Gy

  • Recurrence diagnosed more than 12 months after the initial course of IMXT

  • Age ≥ 18 and < 70 years of age

  • Karnofsky Performance Score ≥70

  • Willing to accept adequate contraception for women with childbearing potential

  • Ability to understand character and individual consequences of the clinical trial

  • Willing to sign the written informed consent; Informed consent must be signed beforethe enrollment in the trial

Exclusion

Exclusion Criteria:

  • Local recurrence of NPC diagnosed within 12 months from the completion of previouscourse of radiation therapy

  • Presence of distant metastasis

  • Technology used other than IMXT (including brachytherapy following IMXT) for thetreatment of initial diagnosis of NPC

  • Pregnant or lactating women

  • Patients who have not yet recovered from acute toxicities of prior therapies

  • A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skinwithin the past 5 years

  • Refusal of the patient to participate into the study

Study Design

Total Participants: 62
Study Start date:
September 01, 2015
Estimated Completion Date:
March 31, 2021

Study Description

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 in the setting of concurrent chemoradiotherapy. Participants will be treated with CIRT with escalating dose starting from 52.5GyE (2.5GyE/daily fraction) to potentially 62.5GyE (2.5GyE/daily fraction) along with concurrent chemotherapy (40 mg/m^2, weekly) to evaluate the maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and within 4 months after the completion of concurrent chemoradiotherapy. 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 in the setting of concurrent chemoradiotherapy 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.

Connect with a study center

  • Shanghai Proton and Heavy Ion Center

    Shanghai, Shanghai 201315
    China

    Active - Recruiting

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