Clinical trial · Observational

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

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

NCT03689556CI-TRIAL-00044470unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Recurrent Nasopharyngeal Carcinoma	Nasopharyngeal Carcinoma	CURATED_BROADER	0.78

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
FLT PET/CT	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
FLT PET/CT
description
Patients with locoregionally recurrent nasopharyngeal carcinoma (LR-NPC) will receive FLT PET/CT scans before CIRT and after completion of CIRT.
interventionNames
1. Diagnostic Test: FLT PET/CT

Primary outcomes (1)

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.
description
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 outcomes (4)

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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 14 Years
Maximum age: 80 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.