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

Recurrent Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03689556
• Other study ID #: SPHIC-TR-HNCNS-2018-19
• Status: Not yet recruiting
• Start date: July 2020
• Est. completion date: August 2024

Study information

• Verified date: April 2020
• Source: Shanghai Proton and Heavy Ion Center
• Contact: Lin Kong, MD
• Phone: +86-21-38296666
• Email: lin.kong[@]sphic.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Recurrent Nasopharyngeal Carcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Proton and Heavy Ion Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Overall survival (OS)	3-year overall survival	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
Secondary	Local progression-free survival (LPFS)	3-year local progression-free survival	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
Secondary	Regional progression-free survival (RPFS)	3-year regional progression-free survival	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
Secondary	Distant metastasis-free survival (DMFS)	3-year distant metastasis-free survival	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