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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Recurrent Nasopharyngeal Carcinoma

Intervention / Treatment
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* Diagnostic Test: FLT PET/CT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FLT PET/CT<br>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<br>* Patients will receive 3'-deoxy-3'-[18F]fluorothymidine (FLT) PET/CT scans before CIRT and after completion of CIRT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity | 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) | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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re-irradiation, FLT PET/CT, carbon ion radiation therapy