Status:
ACTIVE_NOT_RECRUITING
Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers
Lead Sponsor:
Duke University
Conditions:
Cancer of the Cervix
Vulvar Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 disea...
Detailed Description
Intra-treatment PETs have only recently been studied in small pilot series. In rectal cancer, a prospective trial from MSKCC demonstrated that a PET-CT obtained in the second week of neoadjuvant chemo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03403465
Start Date
March 27 2018
End Date
April 5 2028
Last Update
November 21 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710