Clinical trial NCT03689556: Examine the Prognostic Role of FLT PET/CT for Patients With LR-NPC Treated by Carbon Ion Therapy
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Nasopharyngeal Carcinoma
Keywords: FLT PET/CT
carbon ion radiation therapy
re-irradiation
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive LR-NPC patients treated at SPHIC will be recruited.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and specificity
timeFrame: 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:
measure: Overall survival (OS)
timeFrame: 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
measure: Local progression-free survival (LPFS)
timeFrame: 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
measure: Regional progression-free survival (RPFS)
timeFrame: 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
measure: Distant metastasis-free survival (DMFS)
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
name: Jiade J Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: