Examine the Prognostic Role of FLT PET/CT for Patients With LR-NPC Treated by Carbon Ion Therapy

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Brief Title

Examine the Prognostic Role of FLT PET/CT for Patients With LR-NPC Treated by Carbon Ion Therapy

Official Title

A Phase II Clinical Trial Evaluating the Role of FLT PET/CT in Predicting Treatment Response of Carbon-ion Radiotherapy for Patients With Locoregionally Recurrent Nasopharyngeal Carcinoma

Brief Summary

      We aim, in this study, to examine whether reduction of FLT PET derived SUV before and after
      carbon ion radiotherapy can predict the treatment response and survivals for patients with
      locoregionally recurrent nasopharyngeal carcinoma.

Detailed Description

      This is a single-arm phase II clinical trial evaluating the prognostic value of FLT PET/CT
      for patients with locoregionally recurrent nasopharyngeal carcinoma. All patients will
      receive FLT PET/CT scans before and after carbon ion radiotherapy (CIRT). The sensitivity and
      specificity of reduction of FLT uptake reduction in terms of predicting the treatment outcome
      evaluated by MRI at 3 months after completion of CIRT according to RECIST 1.1. Its predictive
      value of OS, LPFS, RPFS and DMFS will be examined as well.

Study Type

Observational

Primary Outcome

Sensitivity and specificity

Secondary Outcome

 Overall survival (OS)

Condition

Recurrent Nasopharyngeal Carcinoma

Intervention

FLT PET/CT

Study Arms / Comparison Groups

 FLT PET/CT
Description:  Patients with locoregionally recurrent nasopharyngeal carcinoma (LR-NPC) will receive FLT PET/CT scans before CIRT and after completion of CIRT.

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

Diagnostic Test

Estimated Enrollment

40

Start Date

July 2020

Completion Date

August 2024

Primary Completion Date

August 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologically confirmed as primary nasopharyngeal carcinoma;

          -  With recurrence at nasopharynx and/or recurrent retropharyngeal lymph node, recurrence
             was diagnosed by imaging or pathology studies;

          -  Already received one course of definitive radiation therapy, at least 6 months ago;

          -  Able to receive contrast MRI scan and PET/CT scan;

          -  ECOG: 0-2;

          -  Anticipated survival time >= 12 months;

          -  With sufficient major organ functions;

          -  Willing to sign informed consent.

        Exclusion Criteria:

          -  Metal implants that might significantly influence the radiation dose distribution;

          -  Dose constrains for organs-at-risk are beyond acceptable limit;

          -  With comorbidities/conditions that might influence the effectiveness of carbon-ion
             therapy;

          -  Pregnant or within lactation period;

          -  Drug/alcohol addiction;

          -  With mental disorder that might impede the completion of therapy.

Gender

All

Ages

14 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Jiade J Lu, MD, +86-21-38296666, [email protected]

Administrative Informations

NCT ID

NCT03689556

Organization ID

SPHIC-TR-HNCNS-2018-19

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

April 2020