Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
258 participants
INTERVENTIONAL
2019-01-17
2026-01-01
Brief Summary
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Detailed Description
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Radiation delivered 4-12 weeks after surgery. Participants in all Arms will receive standard vaginal dilator for use after treatment (to promote healing). 3 month, 1 year and 2 year follow up assessments are performed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ARM A: 3 treatments of 7Gy
Arm A: accepted randomization to HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy
HDR vaginal brachytherapy
HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
ARM B: 6 treatment of 4Gy
Arm B: accepted randomization to HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy
HDR vaginal brachytherapy
HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
ARM AB: 6 treatment of 4Gy
Arm AB: initially randomized to ARM A but wanted to switch to ARM B treatment of HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy
HDR vaginal brachytherapy
HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
ARM BA: 3 treatments of 7Gy
initially randomized to ARM B but wanted to switch to ARM A of HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy
HDR vaginal brachytherapy
HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
Interventions
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HDR vaginal brachytherapy
HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
Eligibility Criteria
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Inclusion Criteria
* Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral Salpingo Oophorectomy (TH-BSO) with or without lymph node dissection.
* Subject must have FIGO Stage I-II (grade 1-3) pathologically proven (histologic) endometrioid cancer, including all subtypes. Serous, clear cell, and carcinosarcoma histologic pathologies are allowed.
* Subjects must have no measurable disease after surgery.
* ECOG Performance Status of 0-2
* Age ≥ 18 years
* Subject must have a life expectancy ≥ 12 months
Exclusion Criteria
* Patients with a history of prior pelvic radiation therapy or if additional pelvic radiation therapy is planned
* Subjects who have not recovered from side effects of agents administered more than 4 weeks prior to the on-study date
* Subjects that require \> 14 weeks between surgery and initiation of radiation therapy on study unless the subject is receiving chemotherapy. Subjects receiving chemotherapy may have radiation therapy initiated within 6 months after surgery.
\* Subjects who do not meet this criteria may still be eligible. The UVA Coordinating Center and Overall Study PI will review each case and inform the site of the approval decision.
* Subjects who are receiving any investigational agents or have had any investigational agent within the 30 days prior to the on-study date
* Subject is unable or unwilling to participate in a study-related procedure
* Pregnant and breastfeeding women are excluded from this study
* Subject is a prisoner
* A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
* Subjects with a history of evidence upon physical examination of central nervous system disease including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (stroke), transient ischemic attack, or subarachnoid hemorrhage within six months of study entry
18 Years
FEMALE
No
Sponsors
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Kara Romano, MD
OTHER
Responsible Party
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Kara Romano, MD
Principle Investigator-MD Radiation Oncology
Principal Investigators
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Kara Romano, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Maryland Medical Center (UMMC)
Baltimore, Maryland, United States
SUNY Upstate Medical University
Syracuse, New York, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20163
Identifier Type: -
Identifier Source: org_study_id
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