Recurrent Nasopharyngeal CarcinomaNCT03689556
Examine the Prognostic Role of FLT PET/CT for Patients With LR-NPC Treated by Carbon Ion Therapy
An observational study of Recurrent Nasopharyngeal Carcinoma, run by Shanghai Proton and Heavy Ion Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Recurrent Nasopharyngeal Carcinoma
- What is being tested?
- FLT PET/CT
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive LR-NPC patients treated at SPHIC will be recruited.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Jiyi Hu, MD contact
About this study
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
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.
Read the 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
- Being tested
- FLT PET/CT
- Keywords
- FLT PET/CT, carbon ion radiation therapy, re-irradiation
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLT PET/CTDiagnostic test
Patients will receive 3'-deoxy-3'-[18F]fluorothymidine (FLT) PET/CT scans before CIRT and after completion of CIRT.
| Study group | Role | What they receive |
|---|---|---|
| FLT PET/CT | Patients with locoregionally recurrent nasopharyngeal carcinoma (LR-NPC) will receive FLT PET/CT scans before CIRT and after completion of CIRT. Receives: Diagnostic Test: FLT PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
3-year overall survival
Measured: 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)
3-year local progression-free survival
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study startJul 2020 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiade J. Lu, Shanghai Proton and Heavy Ion Center
- Investigators
- Jiade J Lu, MD, Principal investigator, Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689556
- Sponsor's protocol ID
- SPHIC-TR-HNCNS-2018-19
- Status last verified
- Apr 2020
- First submitted
- 26 Sep 2018
- Last updated
- 6 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03689556
- Acronym / sponsor ID
- SPHIC-TR-HNCNS-2018-19
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Keywords
- FLT PET/CT, carbon ion radiation therapy, re-irradiation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLT PET/CT | – | Diagnostic Test: FLT PET/CTPatients with locoregionally recurrent nasopharyngeal carcinoma (LR-NPC) will receive FLT PET/CT scans before CIRT and after completion of CIRT. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive LR-NPC patients treated at SPHIC will be recruited.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLT PET/CTPatients will receive 3'-deoxy-3'-[18F]fluorothymidine (FLT) PET/CT scans before CIRT and after completion of CIRT. | Diagnostic test | FLT PET/CT |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiyi Hu, MD contact
Jiade J Lu, MD principal investigator
Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Nasopharyngeal Carcinoma, run by Shanghai Proton and Heavy Ion Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Kong, MD (+86-21-38296666, lin.kong@sphic.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.