Back to resultsEffect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients
Primary Purpose
Oral Cancer, Radiotherapy; Complications
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PET/CT
Sponsored by
About this trial
This is an interventional treatment trial for Oral Cancer focused on measuring PET/CT
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
PET/CT
Outcomes
Primary Outcome Measures
progress free survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03008694
Brief Title
Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients
Official Title
Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer, Radiotherapy; Complications
Keywords
PET/CT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
PET/CT
Intervention Type
Device
Intervention Name(s)
PET/CT
Intervention Description
pet/ct is used as radiotherapy simulation
Primary Outcome Measure Information:
Title
progress free survival
Time Frame
baseline to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients
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