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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Endometrial Cancer
• Intervention / Treatment: Radiation: External beam Radiotherapy

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincent Basehart; Phone Number: 310-267-8954; Email: vbasehart@mednet.ucla.edu
• Study Contact Backup: Name: Christy Palodichuk; Phone Number: 310-794-2971; Email: cpalodichuk@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California at Los Angeles
      • Contact: Vincent Basehart; Phone Number: 310-267-8954; Email: vbasehart@mednet.ucla.edu
      • Principal Investigator: Puja S. Venkat, MD
      • Contact: Christy Palodichuk; Phone Number: +1 310-794-2971; Email: cpalodichuk@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Must not meet indications for receiving concurrent chemotherapy as standard of care
• Active treatment of a separate malignancy
• History of prior irradiation to the area to be treated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypofractionated External beam Radiotherapy; 5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT).	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; Other Names: Hypofractionated External beam Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate acute radiation toxicity	Evaluate acute radiation toxicity according to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0). Acute toxicity is defined as treatment-related adverse events occurring within 12 weeks of completion of radiotherapy.	treatment to 12 weeks after completion of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate patient-reported quality-of-life European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-EN24)	Evaluate patient-reported quality-of-life scores using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). The EORTC QLQ-EN24 is a 24-item instrument designed to assess various aspects of treatment-related quality of life specifically in patients undergoing treatment for endometrial cancer. We will collect data pre-treatment and 3, 6-, 12-, 18-, and 24-months post-treatment. The EORTC QLQ-EN24 uses a 4-point response scale for most items: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. A higher score indicates worse quality of life.	treatment to 24 weeks after completion of radiotherapy
Evaluate late toxicity	Evaluate late toxicity according to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0). Late toxicity is defined as treatment-related adverse events occurring more than 12 weeks after completion of radiotherapy.	12 weeks after completion of radiotherapy until 5 years after completion of radiotherapy
Evaluate local control	Evaluating control of the treated tumor. Local control will be estimated using Kaplan-Meier analysis at 5 years.	treatment to 5 years after completion of radiotherapy
Evaluate regional control	Evaluating control of disease within the abdomen and pelvis. Regional control will be estimated using Kaplan-Meier analysis at 5 years.	treatment to 5 years after completion of radiotherapy
Evaluate distant metastasis	Evaluating the spread of the disease to distant sites. Distant metastasis will be estimated using Kaplan-Meier analysis at 5 years.	treatment to 5 years after completion of radiotherapy
Evaluate progression-free survival	Evaluating patient survival free from any disease progression (local, regional, or distant). Progression-free survival will be estimated using Kaplan-Meier analysis at 5 years.	treatment to 5 years after completion of radiotherapy
Evaluate patient-reported quality-of-life European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)	Evaluate patient-reported quality-of-life scores using European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (QLQ) C30 (EORTC QLQ-C30). The EORTC QLQ-C30 is a 30-item instrument designed to assess various aspects of the overall quality of life in patients with cancer. We will collect data pre-treatment and 3, 6-, 12-, 18-, and 24-months post-treatment. The EORTC QLQ-C30 uses a 4-point response scale for most items: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. A higher score indicates worse quality of life.	treatment to 24 weeks after completion of radiotherapy

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Investigators: Principal Investigator: Puja S. Venkat, MD, University of California at Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2024
• Primary Completion (Estimated): July 26, 2031
• Study Completion (Estimated): July 26, 2032

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: SBRT; endometrial; cervical
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: 23-001976

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No