NCT06538337

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators hypothesize that adaptive planning with either computed tomography (CT) or magnetic resonance imaging (MRI) guidance may offer improved SBRT plans for postoperative gynecological cancer patients due to issues with anatomic variation between and during fractions of radiation therapy. Treatment on an MRI-guided linear accelerator with adaptive planning capabilities has been shown to significantly improve acute toxicity in the setting of prostate SBRT compared to conventional linear accelerators.10 The investigators, therefore, propose using adaptive planning with CT- or MRI-guidance to deliver 30 Gy in 5 fraction adjuvant SBRT to the pelvis for endometrial and cervical cancer patients. Stereotactic Body Radiation Therapy (SBRT) with adaptive planning will be delivered following surgical resection of the primary tumor. Patients will receive 6.0 Gy x 5 fractions delivered once every other day. Patients will not be treated on weekends or holidays as is standard practice for radiation treatments. Patients will be seen by the radiation oncologist within the first 3 months after completion of radiation therapy. For patients who live a distance far enough away from the University of California at Los Angeles (UCLA) where travel would be challenging for the patient, a phone or telemedicine follow-up will be considered acceptable. After this, follow-up will be performed every 6 months (+/- 4 weeks) for 5 years following completion of radiotherapy. Patients will be followed clinically and/or radiographically per physician discretion. SCHEMA Diagnosis of endometrial or cervical cancer Surgical resection of primary tumor Multidisciplinary discussion and recommendation for adjuvant radiotherapy to the pelvis Patient enrollment in HERA clinical trial Simulation scans to plan post-operative radiotherapy Five fractions of radiation therapy using adaptive planning and CT or MRI guidance (6 Gy per fraction) delivered once every other day excluding weekends and holidays Follow-up within 3 months of completion of radiotherapy Follow-up every 6 months (+/- 4 weeks) until 5 years of completion of radiotherapy

Conditions

• Endometrial Cancer
• Cervical Cancer

Interventions

Type	Name	Description
RADIATION	External beam Radiotherapy	Five fractions of radiation therapy using adaptive planning and CT or MRI guidance (6 Gy per fraction) delivered once every other day excluding weekends and holidays

Timeline

• Start date: 2024-07-24
• Primary completion: 2031-07-26
• Completion: 2032-07-26
• First posted: 2024-08-05
• Last updated: 2025-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study