Standard Dose Fractionation Regimens for Vaginal Brachytherapy in Treating Sexual Dysfunction in Patients with Stage I-II Endometrial Cancer After Surgery

Status: Active

Description

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.

Eligibility Criteria

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
  • Subject must have a life expectancy >= 12 months

Exclusion Criteria

  • Disease of more advanced stage (FIGO stage III-IV) or disease for which adjuvant external beam radiation therapy or chemotherapy is indicated
  • 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 radiotherapy on study
  • 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

Locations & Contacts

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Contact: Timothy Norman Showalter
Phone: 434-924-9412
Email: tns3b@virginia.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine if the proportion of participants with patient-reported sexual dysfunction (PRSD) at 1 year (from baseline before brachytherapy) is lower for participants receiving high dose rate (HDR) vaginal brachytherapy 4 Gy x 6 fractions (Arm 2) compared to participants receiving HDR vaginal brachytherapy 7 Gy x 3 fractions (Arm 1) for early stage endometrial cancer.

SECONDARY OBJECTIVES:

I. To determine if the change in vaginal length from baseline is less for participants in Arm 2 compared to participants in Arm 1.

II. To obtain estimates of the differences in health care costs due to brachytherapy treatment with the two dose fractionation schedules.

III. To estimate the association between patient-reported sexual function and change in vaginal length.

IV. To determine if the proportion of participants with patient-reported sexual dysfunction (PRSD) at 2 years (from baseline before brachytherapy) is lower for participants receiving HDR vaginal brachytherapy 4 Gy x 6 fractions (Arm 2) compared to participants receiving HDR vaginal brachytherapy 7 Gy x 3 fractions (Arm 1) for early stage endometrial cancer.

EXPLORATORY OBJECTIVES:

I. To estimate the difference between the two dose fractionation schedules in local control of disease.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (HIGH FRACTIONATION REGIMEN): Patients undergo 3 high fractionation doses of high-dose-rate vaginal brachytherapy over 2 weeks, 4-12 weeks after surgery. Within 2-4 weeks after radiation therapy, patients utilize a standard vaginal dilator 3 times a week.

ARM II (LOW FRACTIONATION REGIMEN): Patients undergo 6 low fractionation doses of high-dose-rate vaginal brachytherapy over 3 weeks, 4-12 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 Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
University of Virginia Cancer Center

Principal Investigator
Timothy Norman Showalter

Trial IDs

Primary ID 21063
Secondary IDs NCI-2019-01046, VCB
Clinicaltrials.gov ID NCT03785288