Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma

February 12, 2020 updated by: Jiade J. Lu, Shanghai Proton and Heavy Ion Center

Phase I/II Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma

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 gray equivalent (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 regimens to evaluate the MTD in terms of acute and subacute 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201321
        • Shanghai Proton and Heavy Ion Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 before the enrollment in the trial

Exclusion Criteria:

  • Local recurrence of NPC diagnosed within 12 months from the completion of previous course of radiation therapy
  • Presence of distant metastasis
  • Technology used other than IMXT (including brachytherapy following IMXT) for the treatment 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 carcinoma in situ of the cervix, basal cell carcinoma and squamous cell carcinoma of the skin within the past 5 years
  • Refusal of the patient to participate into the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CIRT Arm (3GyE per fraction)
Patients included in this arm were treated with carbon ion radiotherapy with a fraction size of 3GyE.
Radiation: Carbon ion radiotherapy (CIRT)
Four dose levels (54GyE, 57GyE, 60GyE, 63GyE) are planned within the Phase I part. Daily fraction of 3 GyE will be delivered for all dose levels. After the recommended dose (RD), i.e., maximal tolerated dose, is determined or if the treatments to 63 GyE are safely delivered, the recommended dose (or 63 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 gross tumor volume plus 3~5mm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Time interval from the start of CIRT to 4 months after the completion of CIRT
Time interval from the start of CIRT to 4 months after the completion of CIRT

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival of all patients
Time Frame: From the diagnosis of local recurrence of NPC, a median of 2 years
From the diagnosis of local recurrence of NPC, a median of 2 years
Progression-free survival of all patients
Time Frame: From the completion of CIRT, a median of 2 years
From the completion of CIRT, a median of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Proton and Heavy Ion Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPHIC-TR-HNCNS-2015-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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