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

NCT ID: NCT03689556

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2024-08-31

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.

Conditions

Recurrent Nasopharyngeal Carcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

FLT PET/CT

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

FLT PET/CT

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

FLT PET/CT

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Proton and Heavy Ion Center

OTHER

Sponsor Role: lead

Responsible Party

Jiade J. Lu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiade J Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

Central Contacts

Lin Kong, MD

Role: CONTACT

lin.kong@sphic.org.cn

+86-21-38296666

Jiyi Hu, MD

Role: CONTACT

jiyi.hu@sphic.org.cn

Other Identifiers

SPHIC-TR-HNCNS-2018-19

Identifier Type: -

Identifier Source: org_study_id