Recurrent Nasopharyngeal Carcinoma
Conditions
Keywords
FLT PET/CT, carbon ion radiation therapy, re-irradiation
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.
Interventions
DIAGNOSTIC_TESTFLT PET/CT
Patients will receive 3'-deoxy-3'-\[18F\]fluorothymidine (FLT) PET/CT scans before CIRT and after completion of CIRT.
Sponsors
Shanghai Proton and Heavy Ion Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity | The reduction of FLT uptake will be calculated over two time points, at the baseline and at the time point that CIRT is completed. | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 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 | 3-year overall survival |
| Local progression-free survival (LPFS) | 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 | 3-year local progression-free survival |
| Regional progression-free survival (RPFS) | 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 | 3-year regional progression-free survival |
| Distant metastasis-free survival (DMFS) | 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 | 3-year distant metastasis-free survival |
Contacts
Primary ContactLin Kong, MD
Backup ContactJiyi Hu, MD
Outcome results
None listed