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

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ClinicalTrials.gov Identifier: NCT03689556
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Jiade J. Lu, Shanghai Proton and Heavy Ion Center

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.

Condition or disease Intervention/treatment
Recurrent Nasopharyngeal Carcinoma Diagnostic Test: FLT PET/CT

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.

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Sensitivity and specificity [ Time Frame: 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 Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 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

  2. Local progression-free survival (LPFS) [ Time Frame: 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

  3. Regional progression-free survival (RPFS) [ Time Frame: 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

  4. Distant metastasis-free survival (DMFS) [ Time Frame: 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



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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive LR-NPC patients treated at SPHIC will be recruited.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689556


Contacts
Contact: Lin Kong, MD +86-21-38296666 lin.kong@sphic.org.cn
Contact: Jiyi Hu, MD jiyi.hu@sphic.org.cn

Sponsors and Collaborators
Shanghai Proton and Heavy Ion Center
Investigators
Principal Investigator: Jiade J Lu, MD Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

Responsible Party: Jiade J. Lu, Professor, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier: NCT03689556     History of Changes
Other Study ID Numbers: SPHIC-TR-HNCNS-2018-19
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jiade J. Lu, Shanghai Proton and Heavy Ion Center:
FLT PET/CT
carbon ion radiation therapy
re-irradiation

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases