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
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary Outcome
Overall survival of all patients
Condition
Nasopharyngeal Carcinoma
Intervention
Carbon ion radiotherapy (CIRT)
Study Arms / Comparison Groups
CIRT Arm (3GyE per fraction)
Description: Patients included in this arm were treated with carbon ion radiotherapy with a fraction size of 3GyE.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
55
Start Date
January 2016
Completion Date
December 2020
Primary Completion Date
December 2020
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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Jiade J Lu, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02795195
Organization ID
SPHIC-TR-HNCNS-2015-03
Responsible Party
Principal Investigator
Study Sponsor
Shanghai Proton and Heavy Ion Center
Study Sponsor
Jiade J Lu, MD, Principal Investigator, Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
Verification Date
February 2020