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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLT PET/CT | Patients with locoregionally recurrent nasopharyngeal carcinoma (LR-NPC) will receive FLT PET/CT scans before CIRT and after completion of CIRT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLT PET/CT | Diagnostic Test | Patients will receive 3'-deoxy-3'-[18F]fluorothymidine (FLT) PET/CT scans before CIRT and after completion of CIRT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Local progression-free survival (LPFS) |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive LR-NPC patients treated at SPHIC will be recruited.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Kong, MD | Contact | +86-21-38296666 | lin.kong@sphic.org.cn | |
| Jiyi Hu, MD | Contact | jiyi.hu@sphic.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jiade J Lu, MD | Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC | Principal Investigator |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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 |
| 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 |
| 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 |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |