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Recruiting NCT03785288

Vaginal Cuff Brachytherapy Fractionation Study

Phase III Interventional Endometrial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HDR vaginal brachytherapy.
Who it may be relevant to
Registry conditions: Endometrial Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Phase III Trial of Two Standard Dose Fractionation Regimes for Adjuvant Vaginal Brachytherapy in Early Stage Endometrial Cancer

Overview

The purpose of this study is to see the effects of two different standard of care treatments of endometrial cancer on sexual dysfunction. This study will compare two standard of care treatments: HDR (high dose radiation) vaginal brachytherapy 3 fractions of 7 Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.

Detailed description

Patients are randomized to HDR vaginal brachytherapy 7 Gy in 3 fractions prescribed at 5mm. Radiation delivered 4-12 weeks after surgery OR HDR vaginal brachytherapy 4Gy in 6 fractions prescribed at the cylinder surface. Patients have the option to request to decline their randomization and switch to the alternate treatment ARM if they prefer.

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.

Interventions

  • Radiation HDR vaginal brachytherapy
    HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions

Primary outcome measures

  • Female Sexual Function Index (FSFI) [Time frame: 1 year]
  • Preference Option Randomized Design (PORD) [Time frame: 1 year]
Secondary outcome measures (2)
  • Vaginal Length Measurement [Time frame: 1 year]
  • Vaginal Length Measurement [Time frame: 2 years]

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 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • University of Maryland Medical Center (UMMC) — Baltimore
  • SUNY Upstate Medical University — Syracuse
  • University of Virginia — Charlottesville

Identifiers

NCT: NCT03785288 · 21063

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗