F Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) for the Delivery of Adaptive Radiation Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancers
- Sponsor
- Duke University
- Enrollment
- 271
- Locations
- 1
- Primary Endpoint
- The number of subjects with benefit from an intra-treatment PET-CT
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to determine the benefit of using positron emission tomography (PET) in addition to the standard (computed tomography) CT to plan radiation therapy for cancer treatment. The information from the PET-CT may allow the investigators to change the radiation plan or the delivery of the radiation to the tumor/tumor site such as the total dose of radiation or the size of the area to receive further radiation. Presently the use of PET scans to adjust radiation therapy during radiation treatment is not standard of care and is being investigated in this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pathologically (histologically or cytologically) proven diagnosis of carcinoma
- •Patients with local or regional nodal disease are eligible.
- •Zubrod Performance Status 0, 1, or
- •Negative serum pregnancy test for women of child bearing potential
- •Patient must sign study-specific informed consent prior to study entry.
Exclusion Criteria
- •No gross disease visible on imaging at the start of radiotherapy
- •Contraindication to PET
- •Complete response by PET achieved with pre-radiation therapy treatment (surgery or chemotherapy)
- •Breast feeding
Outcomes
Primary Outcomes
The number of subjects with benefit from an intra-treatment PET-CT
Time Frame: 3 years
This benefit lies in the potential to adapt the treatment plan based on an intratreatment PET-CT. This may also be of significant prognostic utility, at an early enough time point to potentially alter treatment accordingly.
Secondary Outcomes
- Measure overall survival (OS)(3 years)
- Measure late toxicities(3 years)
- Measure acute toxicities(During radiation therapy and within 30 days of the last radiation treatment)
- Locoregional control.(Day of intra treatment PET-CT/ approx 2-4 hours)
- Freedom from distant metastases(3 years)