Clinical trial NCT06538337: Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers
Official title: Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers (HERA Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Cervical Cancer
Keywords: endometrial
cervical
SBRT
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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

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

Primary outcomes:
measure: Evaluate acute radiation toxicity
timeFrame: treatment to 12 weeks after completion of radiotherapy
Secondary outcomes:
measure: Evaluate patient-reported quality-of-life European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)
timeFrame: treatment to 24 weeks after completion of radiotherapy
measure: Evaluate patient-reported quality-of-life European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-EN24)
timeFrame: treatment to 24 weeks after completion of radiotherapy
measure: Evaluate late toxicity
timeFrame: 12 weeks after completion of radiotherapy until 5 years after completion of radiotherapy
measure: Evaluate local control
timeFrame: treatment to 5 years after completion of radiotherapy
measure: Evaluate regional control
timeFrame: treatment to 5 years after completion of radiotherapy
measure: Evaluate distant metastasis
timeFrame: treatment to 5 years after completion of radiotherapy
measure: Evaluate progression-free survival
timeFrame: treatment to 5 years after completion of radiotherapy
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
Study officials:
affiliation: University of California at Los Angeles
name: Puja S. Venkat, MD
role: PRINCIPAL_INVESTIGATOR
References: