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

Shanghai Proton and Heavy Ion Center40 enrolled

Overview

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.

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

Conditions

Recurrent Nasopharyngeal Carcinoma

Interventions

FLT PET/CTDIAGNOSTIC_TEST

Patients will receive 3'-deoxy-3'-\[18F\]fluorothymidine (FLT) PET/CT scans before CIRT and after completion of CIRT.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

Overall survival (OS)

3-year overall survival

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

Local progression-free survival (LPFS)

3-year local progression-free survival

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

Regional progression-free survival (RPFS)

3-year regional progression-free survival

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

Distant metastasis-free survival (DMFS)

3-year distant metastasis-free survival

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

Central Contacts

Lin Kong, MD

CONTACT

+86-21-38296666 lin.kong@sphic.org.cn

Jiyi Hu, MD

CONTACT

jiyi.hu@sphic.org.cn

Data from ClinicalTrials.gov

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