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

NCT03689556 | Unknown

• 1 other identifier: SPHIC-TR-HNCNS-2018-19
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Recurrent Nasopharyngeal Carcinoma

Keywords

FLT PET/CT; carbon ion radiation therapy; re-irradiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

FLT PET/CT

Patients with locoregionally recurrent nasopharyngeal carcinoma (LR-NPC) will receive FLT PET/CT scans before CIRT and after completion of CIRT.

Diagnostic Test: FLT PET/CT

Interventions

FLT PET/CT DIAGNOSTIC_TEST

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

FLT PET/CT

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive LR-NPC patients treated at SPHIC will be recruited.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jiade J Lu, MD

  Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Kong, MD

CONTACT

+86-21-38296666; lin.kong@sphic.org.cn

Jiyi Hu, MD

CONTACT

jiyi.hu@sphic.org.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: July 1, 2020
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: April 6, 2020

Record last verified: 2020-04