Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Puja S. Venkat, MD

Description

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.

Official Title

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

Details

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

Keywords

Endometrial Cancer, Cervical Cancer, endometrial, cervical, SBRT, Uterine Cervical Neoplasms, Endometrial Neoplasms, External beam Radiotherapy, Hypofractionated External beam Radiotherapy

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • University of California at Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Puja S. Venkat, MD
    Department Vice Chair, Radiation Oncology, Medicine. Authored (or co-authored) 35 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT06538337
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated