Clinical trial NCT03422198: Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer
Official title: Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Endometrial Clear Cell Adenocarcinoma
Endometrial Endometrioid Adenocarcinoma
Endometrial Serous Adenocarcinoma
Stage I Uterine Corpus Cancer
Stage IA Uterine Corpus Cancer
Stage IB Uterine Corpus Cancer
Stage II Uterine Corpus Cancer
Uterine Corpus Carcinosarcoma
Uterine Corpus Sarcoma
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 188
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate the non-inferiority of participant health related quality of life (HRQOL) using the Global Health Score from the Quality of Life Questionnaire Core 30 (QLQ-C30) in the 2 arms one month after treatment.

SECONDARY OBJECTIVES:

I. Compare treatment-related symptoms on HRQOL using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), question 48 between the two treatment arms.

II. Compare cost effectiveness between the two treatment arms.

TERTIARY OBJECTIVES:

I. Report vaginal, bowel, and bladder symptoms on HRQOL using the EORTC EN24 the two treatment arms.

II. Evaluate toxicities between the two treatment arms.

III. Compare local recurrence and document patterns of recurrence between the two treatment arms. There will be two analyses: A single interim evaluation of patterns of recurrence will be performed after a minimum of 75 participants have been accrued, and the second evaluation will be performed at the end of the study.

IV. Evaluate and compare doses to organs at risk (bladder, rectum, sigmoid colon, and urethra) and the prescribed target in the two arms.

V. Compare total distance traveled to the cancer center for study related visits.

OUTLINE: Participants are randomized to 1 of 2 arms.

Arm I: Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.

Arm II: Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.

After completion of study treatment, participants are followed up at 1, 6, and 12 months.

COHORT 2 (PILOT EXPANSION)

PRIMARY OBJECTIVES:

I. The primary objective is to evaluate the frequency and severity of participant-reported financial toxicity in participants with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one-month post-VCB.

EXPLORATORY OBJECTIVES:

I. Exploratory objectives will include evaluation of differences in participant-reported financial toxicity, between cohorts, to assess any impact of treatment duration on outcomes.

II. Exploratory objectives include evaluation of patient-reported diet and physical activity levels and quality of life in patients with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one-month post-VCB.

Eligibility criteria: 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, with one of the following combinations of stage and grade:

  * Stage IA, grade 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.
* Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks.

Primary outcomes:
measure: Change in Quality of Life From Baseline to 1 Month
timeFrame: At 1 month post treatment
measure: Cohort 2: Participant-Reported Financial Toxicity
timeFrame: One month after brachytherapy
Secondary outcomes:
measure: Treatment-related Symptoms on HRQOL Using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), Question 48
timeFrame: one month post-treatment
measure: USD Amount Charged for Procedures
timeFrame: Approximately 6 months after treatment
measure: Cohort 2: Participant-Reported Diet
timeFrame: One month after brachytherapy
measure: Cohort 2: Participant-Reported Activity Levels
timeFrame: One month after brachytherapy
measure: Cohort 2: Financial Toxicity Correlated With Quality of Life
timeFrame: One month after brachytherapy
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Center
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Intermountain Medical Center / LDS Hospital
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Cristina DeCesaris, MD
role: PRINCIPAL_INVESTIGATOR
References: