Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer (SAVE)

Utah System of Higher Education (USHE)

Status and phase

Enrolling

Phase 3

Conditions

Stage I Uterine Corpus Cancer

Endometrial Serous Adenocarcinoma

Uterine Corpus Carcinosarcoma

Stage II Uterine Corpus Cancer

Endometrial Clear Cell Adenocarcinoma

Stage IA Uterine Corpus Cancer

Stage IB Uterine Corpus Cancer

Endometrial Endometrioid Adenocarcinoma

Uterine Corpus Sarcoma

Treatments

Radiation: Vaginal Cuff Brachytherapy

Radiation: Short course vaginal cuff brachytherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03422198

HCI103841

NCI-2018-00011 (Registry Identifier)

Details and patient eligibility

About

This randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating participants with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells.

After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.

Full description

Endometrial cancer is the most common gynecologic cancer in the Western world and primarily affects postmenopausal women. The primary form of treatment is surgery, consisting of a total abdominal or laparoscopic hysterectomy and bilateral salpingo-oophorectomy. Adjuvant radiotherapy for endometrial cancer has been studied in prospective trials for at least four decades. All trials have demonstrated an improvement in local regional control. However, improvement in survival has not been observed in prospective randomized trials in early-stage patients.

There is great heterogeneity in prognoses in stage I patients. National Comprehensive Cancer Network (NCCN) guidelines consequently recommend no treatment in general for low-stage patients, adjuvant brachytherapy for patients with intermediate- and high-intermediate-risk disease, and for patients with deeply invasive tumors with high-grade lesions, external beam radiotherapy is an option (NCCN Guidelines 2016). Over the ensuing decades, there has been a shift toward increasing use of vaginal cuff brachytherapy.

This is a phase III, unblinded, randomized trial comparing an experimental arm and a control arm of vaginal cuff brachytherapy: The experimental arm will treat subjects with 2 fractions of vaginal brachytherapy. The control arm will treat subjects with standard-of-care vaginal cuff brachytherapy of 3-5 fractions. Patients will be randomized 1:1 to the different treatment arms.

After completion of cohort 1 (108 participants), the protocol was expanded to add a second cohort of 80 additional participants, and reopened study recruitment.

Cohort 1 evaluated the non-inferiority of patient Health Related Quality of Life (HRQOL) in the experimental arm compared to the control arm using the Global Health Status from the EORTC QLQ-C30. Cohort 2 will evaluate the frequency and severity of patient-reported financial toxicity in patients with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one month post-VCB.

Enrollment

188 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear cell, to include tumors originating in the cervix, but are primarily located in the uterus, and for whom vaginal cuff brachytherapy is indicated. Carcinosarcoma and other sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) stage I and stage II, with one of the following combinations of stage and grade:
- Stage IA, grade 1 with LVSI, 2, 3
- Stage IB, grades 1-3
- Stage II, grades 1-3
- Stage IIIA, grades 1-3, not receiving EBRT as part of adjuvant therapy.
Participants post-hysterectomy and free from residual disease.
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance status 0-2.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Life expectancy of >2 years.

Exclusion criteria

Stages of endometrial carcinoma other than described.
Previous pelvic radiotherapy.
Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.