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

NCT ID: NCT06538337

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-24
• Study Completion Date: 2032-07-26

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypofractionated External beam Radiotherapy

5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT).

Group Type: EXPERIMENTAL

External beam Radiotherapy

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

Other Intervention Names

Hypofractionated External beam Radiotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Puja S. Venkat, MD

Role: PRINCIPAL_INVESTIGATOR

University of California at Los Angeles

Locations

University of California at Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christy Palodichuk

Role: CONTACT

cpalodichuk@mednet.ucla.edu

310-794-2971

Vincent Basehart

Role: CONTACT

vbasehart@mednet.ucla.edu

310-267-8954

Facility Contacts

Christy Palodichuk

Role: primary

cpalodichuk@mednet.ucla.edu

+1 310-794-2971

Vincent Basehart

Role: backup

vbasehart@mednet.ucla.edu

310-267-8954

Other Identifiers

23-001976

Identifier Type: -

Identifier Source: org_study_id