Clinical trial NCT03785288: Vaginal Cuff Brachytherapy Fractionation Study
Official title: A Randomized Phase III Trial of Two Standard Dose Fractionation Regimes for Adjuvant Vaginal Brachytherapy in Early Stage Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Endometrial Cancer
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 258
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will compare two standard of care treatments: HDR vaginal brachytherapy 3 fractions of 7Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Female Sexual Function Index (FSFI)
timeFrame: 1 year
measure: Preference Option Randomized Design (PORD)
timeFrame: 1 year
Secondary outcomes:
measure: Vaginal Length Measurement
timeFrame: 1 year
measure: Vaginal Length Measurement
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center (UMMC)
state: Maryland
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Kara Romano, MD
role: PRINCIPAL_INVESTIGATOR
References: