Oral CancerPhase 2NCT03008694
Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients
A Phase 2 study testing PET/CT in people with Oral Cancer and Radiotherapy; Complications, run by Zhongnan Hospital.
Trial summary
This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in oral Cancer patients. Progress-free survival (PFS) will be compared with historical control as defined in the protocol Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer, Radiotherapy; Complications
- What is being tested?
- PET/CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2019
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed oral squamous-cell carcinoma
- Age > 17 years
- Signed informed consent
- ECOG Performance status 0-2
- Must be able to start RT within 4 weeks after PET/CT simulation
Who cannot join
- stage IV disease diagnosed before acquisition of staging PET/CT
- prior radiotherapy to oral and neck
- Unable to understand study participation
- Claustrophobia
- pregnant or breast feeding mothers
About this study
Official title: Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral
This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in oral Cancer patients. Progress-free survival (PFS) will be compared with historical control as defined in the protocol
Read the detailed description
Radiotherapy improves local control and overall survival for oral cavity cancer patients after surgery. However, limited locoregional control remains a key issue in the management of oral cavity carcinomas. Appropriate target selection is a key issue in the radiotherapy of oral cavity cancer. The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of oral cancer
- Conditions
- Oral Cancer, Radiotherapy; Complications
- Being tested
- PET/CT
- Keywords
- PET/CT
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDevice
pet/ct is used as radiotherapy simulation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PET/CT Receives: Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress free survival
Measured: baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yahua zhong, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008694
- Sponsor's protocol ID
- ZhongnanH
- Status last verified
- Dec 2016
- First submitted
- 23 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral
- ClinicalTrials.gov ID
- NCT03008694
- Acronym / sponsor ID
- ZhongnanH
- Conditions
- Oral Cancer, Radiotherapy; Complications
- Keywords
- PET/CT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 2 Jan 2017 (estimated)
- 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.
This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in oral Cancer patients. Progress-free survival (PFS) will be compared with historical control as defined in the protocol
Detailed description
Radiotherapy improves local control and overall survival for oral cavity cancer patients after surgery. However, limited locoregional control remains a key issue in the management of oral cavity carcinomas. Appropriate target selection is a key issue in the radiotherapy of oral cavity cancer. The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of oral cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: PET/CTPET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed oral squamous-cell carcinoma
- Age > 17 years
- Signed informed consent
- ECOG Performance status 0-2
- Must be able to start RT within 4 weeks after PET/CT simulation
Key exclusion criteria (5 listed)
- stage IV disease diagnosed before acquisition of staging PET/CT
- prior radiotherapy to oral and neck
- Unable to understand study participation
- Claustrophobia
- pregnant or breast feeding mothers
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 |
|---|---|---|
| PET/CTpet/ct is used as radiotherapy simulation | Device | 1 |
Primary outcome
progress free survival
Time frame: baseline to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PET/CT in people with Oral Cancer and Radiotherapy; Complications, run by Zhongnan Hospital.
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 5 inclusion and 5 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 2 Jan 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progress free survival (time frame: baseline to 2 years). 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 2 Jan 2017.