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

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

NCT ID: NCT06538337

Condition: Endometrial Cancer
Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms

Conditions: Keywords:
endometrial
cervical
SBRT

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Single arm, non-randomized, trial of adjuvant SBRT to the pelvis with adaptive planning using CT or MRI guidance for endometrial and cervical cancers

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: External beam Radiotherapy
Description: 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
Arm group label: Hypofractionated External beam Radiotherapy

Other name: Hypofractionated External beam Radiotherapy

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

Criteria for 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

Gender: Female

Gender based: Yes

Gender description: Study considers endometrial and cervical cancer which are defined as physically occurring in the uterus and the cervix.

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of California at Los Angeles

Address:
City: Los Angeles
Zip: 90095
Country: United States

Status: Recruiting

Contact:
Last name: Christy Palodichuk

Phone: 310-794-2971
Email: cpalodichuk@mednet.ucla.edu

Contact backup:
Last name: Vincent Basehart

Phone: 310-267-8954
Email: vbasehart@mednet.ucla.edu

Investigator:
Last name: Puja S. Venkat, MD
Email: Principal Investigator

Start date: July 24, 2024

Completion date: July 26, 2032

Lead sponsor:
Agency: Jonsson Comprehensive Cancer Center
Agency class: Other

Source: Jonsson Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06538337