Vaginal Cuff Brachytherapy Fractionation Study

Patients are randomized to Arm 1: HDR vaginal brachytherapy 7 Gy in 3 fractions prescribed at
5mm. Radiation delivered 4-12 weeks after surgery OR Arm 2: HDR vaginal brachytherapy 4Gy in
6 fractions prescribed at the cylinder surface. Radiation delivered 4-12 weeks after surgery.
Participants in both arms will receive standard vaginal dilator for use after treatment (to
promote healing). 1 and 2 year follow up assessments are performed.

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 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