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Standard Dose Fractionation Regimens for Vaginal Brachytherapy in Treating Sexual Dysfunction in Patients with Stage I-II Endometrial Cancer After Surgery
Trial Status: active
This phase III trial studies how well standard high or low dose fractionation regimen for vaginal brachytherapy works in treating sexual dysfunction in patients with stage I-II endometrial cancer after surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Undergoing a low dose fractionation regimen may work better than a high dose fractionation regimen in treating sexual dysfunction in patients with stage I-II endometrial cancer.
Inclusion Criteria
Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator
Surgery consisted of total abdominal or laparoscopic hysterectomy and bilateral salpingo oophorectomy (TH-BSO) with or without lymph node dissection
Subject must have Federation of Gynecology and Obstetrics (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
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Age >= 18 years
Subject must have a life expectancy >= 12 months
Exclusion Criteria
Disease of more advanced stage (FIGO stage III-IV)
Patients with 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 on-study date
Subjects that require > 14 weeks between surgery and initiation of radiation therapy on study. Subjects receiving chemotherapy may have radiation therapy initiated within 6 months after surgery
* Subjects who do not meet this criteria due to extenuating circumstances (i.e. coronavirus disease 2019 [COVID-19] quarantine) but meet all other eligibility criteria may still be eligible. The University of Virginia (UVA) Coordinating Center and overall study principal investigator (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 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 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03785288.
I. To obtain preliminary estimates of the impact of participant compositions in a preference option randomized design (PORD) for assessing the comparative effectiveness of receiving high dose rate (HDR) vaginal brachytherapy 4 Gy x 6 fractions (Arm B) compared to receiving HDR vaginal brachytherapy 7 Gy x 3 fractions (Arm A) for early stage endometrial cancer research.
SECONDARY OBJECTIVES:
I. To estimate whether the group specific proportion of participants with patient-reported sexual dysfunction (PRSD) at 1 year and 2 years (from baseline before brachytherapy) is lower for participants receiving HDR vaginal brachytherapy 4 Gy x 6 fractions (Arm B) compared to participants receiving HDR vaginal brachytherapy 7 Gy x 3 fractions (Arm A) for early stage endometrial cancer.
II. To estimate whether the change in vaginal length from baseline is less for participants in Arm B compared to participants in Arm A.
III. To obtain estimates of the differences in health care costs due to brachytherapy treatment with the two dose fractionation schedules.
IV. To estimate the association between patient-reported sexual function and change in vaginal length.
EXPLORATORY OBJECTIVE:
I. To estimate the difference between the two dose fractionation schedules in local control of disease.
II. To explore the differences in Female Sexual Distress for participants in Arms A, B, AB, and BA.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A (HIGH FRACTIONATION REGIMEN): Patients undergo 3 high fractionation doses of high-dose-rate vaginal brachytherapy over 2 weeks, 4-14 weeks after surgery. Within 2-4 weeks after radiation therapy, patients utilize a standard vaginal dilator 3 times a week. .
ARM B (LOW FRACTIONATION REGIMEN): Patients undergo 6 low fractionation doses of high-dose-rate vaginal brachytherapy over 3 weeks, 4-14 weeks after surgery. Within 2-4 weeks after radiation therapy, patients utilize a standard vaginal dilator 3 times a week..
After completion of study treatment, patients are followed up at 3 months, 1, and 2 years.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationUniversity of Virginia Cancer Center
