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

April 3, 2020 updated by: Jiade J. Lu, Shanghai Proton and Heavy Ion Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Contacts and Locations

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

Study Contact

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

14 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive LR-NPC patients treated at SPHIC will be recruited.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FLT PET/CT
Patients with locoregionally recurrent nasopharyngeal carcinoma (LR-NPC) will receive FLT PET/CT scans before CIRT and after completion of CIRT.
Diagnostic test: FLT PET/CT
Patients will receive 3'-deoxy-3'-[18F]fluorothymidine (FLT) PET/CT scans before CIRT and after completion of CIRT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity
Time Frame: The reduction of FLT uptake will be calculated over two time points, at the baseline and at the time point that CIRT is completed.
The sensitivity and specificity of FLT uptake reduction in predicting the treatment response evaluated by MRI scan at 3 months after completion of CIRT.
The reduction of FLT uptake will be calculated over two time points, at the baseline and at the time point that CIRT is completed.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Duration from the date the diagnosis of LR-NPC is made until date of patient death or the last follow-up, whichever comes first, assessed up to 36 months
3-year overall survival
Duration from the date the diagnosis of LR-NPC is made until date of patient death or the last follow-up, whichever comes first, assessed up to 36 months
Local progression-free survival (LPFS)
Time Frame: Duration from the date the diagnosis of LR-NPC is made until date of documented local failure or the last follow-up/patient death, whichever comes first, assessed up to 36 months
3-year local progression-free survival
Duration from the date the diagnosis of LR-NPC is made until date of documented local failure or the last follow-up/patient death, whichever comes first, assessed up to 36 months
Regional progression-free survival (RPFS)
Time Frame: Duration from the date the diagnosis of LR-NPC is made until date of documented regional failure or the last follow-up/patient death, whichever comes first, assessed up to 36 months
3-year regional progression-free survival
Duration from the date the diagnosis of LR-NPC is made until date of documented regional failure or the last follow-up/patient death, whichever comes first, assessed up to 36 months
Distant metastasis-free survival (DMFS)
Time Frame: Duration from the date the diagnosis of LR-NPC is made until date of documented distant metastasis or the last follow-up/patient death, whichever comes first, assessed up to 36 months
3-year distant metastasis-free survival
Duration from the date the diagnosis of LR-NPC is made until date of documented distant metastasis or the last follow-up/patient death, whichever comes first, assessed up to 36 months

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 (ANTICIPATED)

July 1, 2020

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2024

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (ACTUAL)

September 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPHIC-TR-HNCNS-2018-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Recurrent Nasopharyngeal Carcinoma

Clinical Trials on FLT PET/CT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe