Vaginal Cuff Brachytherapy Fractionation Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Endometrial Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study will compare two standard of care treatments: HDR vaginal brachytherapy 3 fractions of 7Gy (Arm 1) to HDR vaginal brachytherapy 6 fractions of 4Gy (Arm 2) for early stage endometrial cancer.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Patients are randomized to Arm 1: HDR vaginal brachytherapy 7 Gy in 3 fractions prescribed at 5mm. Radiation delivered 4-12 weeks after surgery OR Arm 2: HDR vaginal brachytherapy 4Gy in 6 fractions prescribed at the cylinder surface. Radiation delivered 4-12 weeks after surgery. Participants in bot...
Patients are randomized to Arm 1: HDR vaginal brachytherapy 7 Gy in 3 fractions prescribed at 5mm. Radiation delivered 4-12 weeks after surgery OR Arm 2: HDR vaginal brachytherapy 4Gy in 6 fractions prescribed at the cylinder surface. Radiation delivered 4-12 weeks after surgery. Participants in both arms will receive standard vaginal dilator for use after treatment (to promote healing). 1 and 2 year follow up assessments are performed.
Tracking Information
- NCT #
- NCT03785288
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Timothy Showalter, MD University of Virginia
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