Head and Neck Cancers Clinical Trial
Official title:
F Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) for the Delivery of Adaptive Radiation Therapy
NCT number | NCT01908504 |
Other study ID # | Pro00033339 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | September 2016 |
Verified date | May 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 271 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 2. - Age = 18 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of subjects with benefit from an intra-treatment PET-CT | 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. | 3 years | |
Secondary | Locoregional control. | This study will evaluate the prognostic value of intra-treatment functional imaging on clinical relevant tumor endpoints (i.e. locoregional control, freedom from distant metastases, and overall survival).Comparison of intra-treatment FDG-PET indices will identify two groups of responses: PET responses and PET non-responses, which will correlate with prognosis. | Day of intra treatment PET-CT/ approx 2-4 hours | |
Secondary | Freedom from distant metastases | Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care, or at the treating investigator's discretion. Frequency of follow up will be determined by the standard practice for the disease site and stage. | 3 years | |
Secondary | Measure overall survival (OS) | Subjects will be evaluated in regular follow up with the investigators according to the standard of care for each disease site. | 3 years | |
Secondary | Measure acute toxicities | Acute toxicity will be assessed weekly as per the standard practice of the treating investigator. | During radiation therapy and within 30 days of the last radiation treatment | |
Secondary | Measure late toxicities | Subjects will be evaluated in regular follow up with measures of treatment related side effects. | 3 years |
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