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Trial record 2 of 5 for:    university of virginia showalter

Vaginal Cuff Brachytherapy Fractionation Study

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ClinicalTrials.gov Identifier: NCT03785288
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Timothy Showalter, MD, University of Virginia

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 (Arm 1) to HDR vaginal brachytherapy 6 fractions of 4Gy (Arm 2) for early stage endometrial cancer.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Radiation: HDR vaginal brachytherapy Phase 3

Detailed Description:
Patients are randomized to Arm 1: HDR vaginal brachytherapy 7 Gy in 3 fractions prescribed at 5mm. Radiation delivered 4-12 weeks after surgery OR Arm 2: HDR vaginal brachytherapy 4Gy in 6 fractions prescribed at the cylinder surface. Radiation delivered 4-12 weeks after surgery. Participants in both arms will receive standard vaginal dilator for use after treatment (to promote healing). 1 and 2 year follow up assessments are performed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will compare two standard of care treatments: HDR vaginal brachytherapy 3 fractions of 7Gy (Arm 1) to HDR vaginal brachytherapy 6 fractions of 4Gy (Arm 2) for early stage endometrial cancer.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Two Standard Dose Fractionation Regimes for Adjuvant Vaginal Brachytherapy in Early Stage Endometrial Cancer
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2023

Arm Intervention/treatment
Active Comparator: HDR VBT 3 fxs of 7Gy
Arm 1: HDR vaginal brachytherapy 3 fractions of 7Gy
Radiation: HDR vaginal brachytherapy
Arm 1: HDR vaginal brachytherapy 7 Gy in 3 fractions ; Arm 2: HDR vaginal brachytherapy 4 Gy in 6 fractions

Active Comparator: HDR VBT 6 fxs of 4Gy
Arm 2: HDR vaginal brachytherapy 6 fractions of 4Gy
Radiation: HDR vaginal brachytherapy
Arm 1: HDR vaginal brachytherapy 7 Gy in 3 fractions ; Arm 2: HDR vaginal brachytherapy 4 Gy in 6 fractions




Primary Outcome Measures :
  1. Female Sexual Function Index (FSFI) [ Time Frame: 1 year ]
    Using the FSFI, compare patient reported sexual dysfunction at 1 year after completion of treatment


Secondary Outcome Measures :
  1. Vaginal Length Measurement [ Time Frame: 1 year ]
    Using vaginal dilator compare patient vaginal measurement 1 year after completion of treatment

  2. Vaginal Length Measurement [ Time Frame: 2 years ]
    Using vaginal dilator compare patient vaginal measurement 2 years after completion of treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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 on-study date
  • Subjects that require > 14 weeks between surgery and initiation of radiotherapy on study
  • Subjects who are receiving any investigational agents or have had any investigational agent within the 30 days prior to 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785288


Contacts
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Contact: Amy Smith, BS 434-243-7231 ext 3-7231 ajb6bb@hscmail.mcc.virginia.edu
Contact: Timothy Showalter, MD (434) 924-9412 ext 4-9412 TNS3B@hscmail.mcc.virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Timothy Showalter, MD       TNS3B@hscmail.mcc.virginia.edu   
Contact: Amy Smith       AJB6BB@hscmail.mcc.virginia.edu   
Sponsors and Collaborators
Timothy Showalter, MD
Investigators
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Principal Investigator: Timothy Showalter, MD University of Virginia

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Responsible Party: Timothy Showalter, MD, Principle Investigator-MD Radiation Oncology, University of Virginia
ClinicalTrials.gov Identifier: NCT03785288     History of Changes
Other Study ID Numbers: 20163
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female