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Vaginal Cuff Brachytherapy Fractionation Study

Primary Purpose

Endometrial Cancer

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

HDR vaginal brachytherapy

About this trial

This is an interventional treatment trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Maryland Medical Center (UMMC)Recruiting
SUNY Upstate Medical UniversityRecruiting
University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

ARM A: 3 treatments of 7Gy

ARM B: 6 treatment of 4Gy

ARM AB: 6 treatment of 4Gy

ARM BA: 3 treatments of 7Gy

Arm Description

Arm A: accepted randomization to HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy

Arm B: accepted randomization to HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy

Arm AB: initially randomized to ARM A but wanted to switch to ARM B treatment of HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy

initially randomized to ARM B but wanted to switch to ARM A of HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy

Outcomes

Primary Outcome Measures

Female Sexual Function Index (FSFI)

Using the FSFI, compare patient reported sexual dysfunction at 1 year after completion of treatment

Preference Option Randomized Design (PORD)

Assessing the comparative effectiveness of receiving HDR vaginal brachytherapy on Arm B or Arm A for early stage endometrial cancer.

Secondary Outcome Measures

Vaginal Length Measurement

Using vaginal dilator compare patient vaginal measurement 1 year after completion of treatment

Vaginal Length Measurement

Using vaginal dilator compare patient vaginal measurement 2 years after completion of treatment

Full Information

NCT ID

NCT03785288

First Posted

November 15, 2018

Last Updated

January 19, 2023

Sponsor

Kara Romano, MD

1. Study Identification

Unique Protocol Identification Number

NCT03785288

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 17, 2019 (Actual)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kara Romano, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

258 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ARM A: 3 treatments of 7Gy

Arm Type

Active Comparator

Arm Description

Arm A: accepted randomization to HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy

Arm Title

ARM B: 6 treatment of 4Gy

Arm Type

Active Comparator

Arm Description

Arm B: accepted randomization to HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy

Arm Title

ARM AB: 6 treatment of 4Gy

Arm Type

Active Comparator

Arm Description

Arm AB: initially randomized to ARM A but wanted to switch to ARM B treatment of HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy

Arm Title

ARM BA: 3 treatments of 7Gy

Arm Type

Active Comparator

Arm Description

initially randomized to ARM B but wanted to switch to ARM A of HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy

Intervention Type

Radiation

Intervention Name(s)

HDR vaginal brachytherapy

Intervention Description

HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions

Primary Outcome Measure Information:

Title

Female Sexual Function Index (FSFI)

Description

Using the FSFI, compare patient reported sexual dysfunction at 1 year after completion of treatment

Time Frame

1 year

Title

Preference Option Randomized Design (PORD)

Description

Assessing the comparative effectiveness of receiving HDR vaginal brachytherapy on Arm B or Arm A for early stage endometrial cancer.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Vaginal Length Measurement

Description

Using vaginal dilator compare patient vaginal measurement 1 year after completion of treatment

Time Frame

1 year

Title

Vaginal Length Measurement

Description

Using vaginal dilator compare patient vaginal measurement 2 years after completion of treatment

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Songserea Wood, BS

Phone

434-243-0008

stw2g@hscmail.mcc.virginia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Dena Synder

DS6HE@hscmail.mcc.virginia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kara Romano, MD

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Maryland Medical Center (UMMC)

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caitlin Eggleston

Phone

410-328-7586

caitlineggleston@umm.edu

First Name & Middle Initial & Last Name & Degree

Sarah McAvoy, MD

First Name & Middle Initial & Last Name & Degree

Elizabeth Nichols, MD

First Name & Middle Initial & Last Name & Degree

Jack J Hong, MD, FACRO

First Name & Middle Initial & Last Name & Degree

Sally Cheston, MD

Facility Name

SUNY Upstate Medical University

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erin Bingham

Phone

315-464-3603

BinghamE@upstate.edu

First Name & Middle Initial & Last Name & Degree

Lindsay Noah-Vermillion

noahverl@upstate.edu

First Name & Middle Initial & Last Name & Degree

Brittany Simone, DO

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kara Romano, MD

KED7C@uvahealth.org

First Name & Middle Initial & Last Name & Degree

Song Wood

STW2G@uvahealth.org

First Name & Middle Initial & Last Name & Degree

Kara Romano, MD

First Name & Middle Initial & Last Name & Degree

Timothy Showalter, MD

First Name & Middle Initial & Last Name & Degree

Leigh Cantrell, MD, MSPH

12. IPD Sharing Statement

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Vaginal Cuff Brachytherapy Fractionation Study

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