Endometrial Cancer
Conditions
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.
Interventions
RADIATIONHDR vaginal brachytherapy
HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
Sponsors
Kara Romano, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index (FSFI) | 1 year | Using the FSFI, compare patient reported sexual dysfunction at 1 year after completion of treatment |
| Preference Option Randomized Design (PORD) | 1 year | Assessing the comparative effectiveness of receiving HDR vaginal brachytherapy on Arm B or Arm A for early stage endometrial cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Length Measurement | 1 year | Using vaginal dilator compare patient vaginal measurement 1 year after completion of treatment |
Countries
United States
Contacts
CONTACTSong Wood
PRINCIPAL_INVESTIGATORKara Romano, MD
University of Virginia
Outcome results
None listed