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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed endometrial or cervical cancer

• Surgical resection of the primary tumor

• 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

• Age ≥ 18 years old

• Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) 0-2

Locations
United States
California
University of California at Los Angeles
RECRUITING
Los Angeles
Contact Information
Primary
Christy Palodichuk
cpalodichuk@mednet.ucla.edu
310-794-2971
Backup
Vincent Basehart
vbasehart@mednet.ucla.edu
310-267-8954
Time Frame
Start Date: 2024-07-24
Estimated Completion Date: 2032-07-26
Participants
Target number of participants: 60
Treatments
Experimental: Hypofractionated External beam Radiotherapy
5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT).
Related Therapeutic Areas
Sponsors
Leads: Jonsson Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov