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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Carbon ion radiotherapy (CIRT)
Sponsored by
Shanghai Proton and Heavy Ion Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring re-irradiation, carbon ion therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Proton and Heavy Ion Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CIRT Arm (3GyE per fraction)

Arm Description

Patients included in this arm were treated with carbon ion radiotherapy with a fraction size of 3GyE.

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Overall survival of all patients
Progression-free survival of all patients

Full Information

First Posted
June 6, 2016
Last Updated
February 12, 2020
Sponsor
Shanghai Proton and Heavy Ion Center
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1. Study Identification

Unique Protocol Identification Number
NCT02795195
Brief Title
Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma
Official Title
Phase I/II Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
re-irradiation, carbon ion therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CIRT Arm (3GyE per fraction)
Arm Type
Experimental
Arm Description
Patients included in this arm were treated with carbon ion radiotherapy with a fraction size of 3GyE.
Intervention Type
Radiation
Intervention Name(s)
Carbon ion radiotherapy (CIRT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Overall survival of all patients
Time Frame
From the diagnosis of local recurrence of NPC, a median of 2 years
Title
Progression-free survival of all patients
Time Frame
From the completion of CIRT, a median of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiade J Lu, MD
Organizational Affiliation
Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201321
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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