Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: External beam Radiotherapy.
- Who it may be relevant to
- Registry conditions: Endometrial Cancer, Cervical Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers (HERA Trial)
Overview
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
Interventions
- 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
Primary outcome measures
- Evaluate acute radiation toxicity [Time frame: treatment to 12 weeks after completion of radiotherapy]
Secondary outcome measures (7)
- Evaluate patient-reported quality-of-life European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) [Time frame: treatment to 24 weeks after completion of radiotherapy]
- Evaluate patient-reported quality-of-life European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-EN24) [Time frame: treatment to 24 weeks after completion of radiotherapy]
- Evaluate late toxicity [Time frame: 12 weeks after completion of radiotherapy until 5 years after completion of radiotherapy]
- Evaluate local control [Time frame: treatment to 5 years after completion of radiotherapy]
- Evaluate regional control [Time frame: treatment to 5 years after completion of radiotherapy]
- Evaluate distant metastasis [Time frame: treatment to 5 years after completion of radiotherapy]
- Evaluate progression-free survival [Time frame: treatment to 5 years after 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California at Los Angeles — Los Angeles
Identifiers
NCT: NCT06538337 · 23-001976