Esophageal Cancer Clinical Trial
Official title:
Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers ( Adaptive PET II)
This study expands on protocol (NCT01908504"PET adaptive RT") designed to evaluate the utility of adaptive PET-CT planning for radiation therapy (RT). Radiation therapy is used in many malignant diseases as a curative treatment modality. However, critical normal tissue is often in close approximation to disease, and portions of such tissue must receive high doses of radiation for appropriate treatment. Positron Emission Tomography (PET) adapted radiation therapy, as defined in the current protocol, may allow for a means of determining the eventual response to therapy, at a time point when adaptation of treatment plan may be possible to improve outcomes. This protocol will build upon the findings the previous protocol (NCT01908504 "PET adaptive RT") that evaluated the utility of intra-treatment PET imaging in multiple types of cancers. The current focus will be more specific to certain types of gastrointestinal and gynecologic cancers treated with RT, identified from the prior study to warrant further research.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Pathologically (histologically or cytologically) proven diagnosis of cervical, vulvar, esophageal and anal canal cancer 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 Positive serum pregnancy test |
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 | 4 years | |
Primary | Pathologic complete response | Pathologic complete response will be collected from pathology reports for subjects who have surgical resection after radiation therapy. | 4 years | |
Primary | 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 | |
Primary | 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. | 4 years | |
Primary | 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 | 4 years | |
Primary | Progression free survival (PFS) | Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care for each disease site | 4 years | |
Secondary | Measure the potential sparing of radiation dose to critical normal tissue | An intra-treatment PET volume adaptive treatment plan may allow for additional sparing of normal tissue by identifying regions of tumor response and corresponding reduction in the target volumes i.e. dosimetric differences in normal tissue will be compared between the initial plan and the adapted plan. | 4 years |
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