RECRUITING

Vaginal Cuff Brachytherapy Fractionation Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Phase III Trial of Two Standard Dose Fractionation Regimes for Adjuvant Vaginal Brachytherapy in Early Stage Endometrial Cancer

Quick Facts

Study Start:2019-01-17

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03785288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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 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

Inclusion Criteria

Exclusion 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

* 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 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

Contacts and Locations

Study Contact

Song Wood

CONTACT

434-243-0008

UVARADONCClinicalTrials@uvahealth.org

UVA SOM MCRO

CONTACT

RVAGINALCUFFTMF@uvahealth.org

Principal Investigator

Kara Romano, MD

PRINCIPAL_INVESTIGATOR

University of Virginia

Study Locations (Sites)

University of Maryland Medical Center (UMMC)

Baltimore, Maryland, 21201

United States

SUNY Upstate Medical University

Syracuse, New York, 13210

United States

University of Virginia

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: Kara Romano, MD

Kara Romano, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-17

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2019-01-17

Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

Endometrial Cancer