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

Shanghai Proton and Heavy Ion Center

Status

Not yet enrolling

Conditions

Recurrent Nasopharyngeal Carcinoma

Treatments

Diagnostic Test: FLT PET/CT

Study type

Observational

Funder types

Other

Identifiers

NCT03689556

SPHIC-TR-HNCNS-2018-19

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

14 to 80 years old

Volunteers

No Healthy Volunteers

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.