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

• Conditions: Recurrent Nasopharyngeal Carcinoma
• Interventions: Diagnostic Test: FLT PET/CT

• Registration Number: NCT03689556
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

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 Timeline

• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-09-28
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-06
• Study Start: 2020-07
• Primary Completion: 2023-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	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
Local progression-free survival (LPFS)	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
Regional progression-free survival (RPFS)	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
Distant metastasis-free survival (DMFS)	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