RECRUITING

Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers

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

After surgery to remove the main endometrial and/or cervical tumor, most women receive radiation therapy. This study uses hypo-fractionated radiation therapy, which is a type of radiation therapy in which the total prescribed dose of radiation is delivered in fewer but larger doses than conventional or standard radiotherapy. This research study aims to determine if hypo-fractionated radiation therapy given after surgery can improve treatment tolerability (i.e., fewer treatments) with comparable side effects. Participants will be in the study for about 5 years: Radiation therapy: * 5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT). * Each treatment session will occur on a weekday (typically consecutive weekdays) and will last approximately an hour. Treatment Follow-Up: * Check-up Appointment and answer questions at 3 months post RT * Check-up Appointments with physical exam every 6 months (+/- 4 weeks) for up to 5 years.

Official Title

Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers (HERA Trial)

Quick Facts

Study Start:2024-07-24
Study Completion:2032-07-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06538337

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 CriteriaExclusion Criteria
  1. * Histologically confirmed endometrial or cervical cancer
  2. * Surgical resection of the primary tumor
  3. * International Federation of Gynecology and Obstetrics (FIGO) Stage IA-IVB endometrial cancer OR FIGO Stage IA-IIA cervical cancer that meets indications for receiving adjuvant pelvic radiotherapy alone as standard of care
  4. * Age ≥ 18 years old
  5. * Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) 0-2
  1. * Must not meet indications for receiving concurrent chemotherapy as standard of care
  2. * Active treatment of a separate malignancy
  3. * History of prior irradiation to the area to be treated

Contacts and Locations

Study Contact

Christy Palodichuk
CONTACT
310-794-2971
cpalodichuk@mednet.ucla.edu
Vincent Basehart
CONTACT
310-267-8954
vbasehart@mednet.ucla.edu

Principal Investigator

Puja S. Venkat, MD
PRINCIPAL_INVESTIGATOR
University of California at Los Angeles

Study Locations (Sites)

University of California at Los Angeles
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

  • Puja S. Venkat, MD, PRINCIPAL_INVESTIGATOR, University of California at Los Angeles

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 Date2024-07-24
Study Completion Date2032-07-26

Study Record Updates

Study Start Date2024-07-24
Study Completion Date2032-07-26

Terms related to this study

Keywords Provided by Researchers

  • endometrial
  • cervical
  • SBRT

Additional Relevant MeSH Terms

  • Endometrial Cancer
  • Cervical Cancer