Endometrial CancerHERANCT06538337
Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers
A study testing External beam Radiotherapy in people with Endometrial Cancer and Cervical Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Cervical Cancer
- What is being tested?
- External beam Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2024to 26 Jul 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California at Los Angeles
Los Angeles, California, 90095
Christy Palodichuk, 310-794-2971, cpalodichuk@mednet.ucla.edu
Vincent Basehart, 310-267-8954, vbasehart@mednet.ucla.edu
About this study
Official title: Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers (HERA Trial)
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.
Read more
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.
Read the 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
- Being tested
- External beam Radiotherapy
- Keywords
- endometrial, cervical, SBRT
- Medical subject headings
- Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External beam RadiotherapyRadiation
Also called Hypofractionated 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
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated External beam Radiotherapy | Experimental | 5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT). Receives: Radiation: External beam Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate acute radiation toxicity
Evaluate acute radiation toxicity according to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0). Acute toxicity is defined as treatment-related adverse events occurring within 12 weeks of completion of radiotherapy.
Measured: treatment to 12 weeks after completion of radiotherapy
Secondary outcomes (7)
Evaluate patient-reported quality-of-life European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)
Evaluate patient-reported quality-of-life scores using European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (QLQ) C30 (EORTC QLQ-C30). The EORTC QLQ-C30 is a 30-item instrument designed to assess various aspects of the overall quality of life in patients with cancer. We will collect data pre-treatment and 3, 6-, 12-, 18-, and 24-months post-treatment.
The EORTC QLQ-C30 uses a 4-point response scale for most items: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much.
A higher score indicates worse quality of life.
Measured: 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)
Evaluate patient-reported quality-of-life scores using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). The EORTC QLQ-EN24 is a 24-item instrument designed to assess various aspects of treatment-related quality of life specifically in patients undergoing treatment for endometrial cancer. We will collect data pre-treatment and 3, 6-, 12-, 18-, and 24-months post-treatment.
The EORTC QLQ-EN24 uses a 4-point response scale for most items: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much.
A higher score indicates worse quality of life.
Measured: treatment to 24 weeks after completion of radiotherapy
Evaluate late toxicity
Evaluate late toxicity according to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0). Late toxicity is defined as treatment-related adverse events occurring more than 12 weeks after completion of radiotherapy.
Measured: 12 weeks after completion of radiotherapy until 5 years after completion of radiotherapy
Evaluate local control
Evaluating control of the treated tumor. Local control will be estimated using Kaplan-Meier analysis at 5 years.
Measured: treatment to 5 years after completion of radiotherapy
Evaluate regional control
Evaluating control of disease within the abdomen and pelvis. Regional control will be estimated using Kaplan-Meier analysis at 5 years.
Measured: treatment to 5 years after completion of radiotherapy
Evaluate distant metastasis
Evaluating the spread of the disease to distant sites. Distant metastasis will be estimated using Kaplan-Meier analysis at 5 years.
Measured: treatment to 5 years after completion of radiotherapy
Evaluate progression-free survival
Evaluating patient survival free from any disease progression (local, regional, or distant). Progression-free survival will be estimated using Kaplan-Meier analysis at 5 years.
Measured: treatment to 5 years after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start24 Jul 2024
- Primary completion26 Jul 2031 (estimated)
- Study completion26 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Puja S. Venkat, MD, Principal investigator, University of California at Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538337
- Sponsor's protocol ID
- 23-001976
- Acronym
- HERA
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers (HERA Trial)
- ClinicalTrials.gov ID
- NCT06538337
- Acronym / sponsor ID
- HERA / 23-001976
- Conditions
- Endometrial Cancer, Cervical Cancer
- Keywords
- endometrial, cervical, SBRT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 26 Jul 2031 (estimated)
- Study completion
- 26 Jul 2032 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated External beam Radiotherapy | Experimental | Radiation: External beam Radiotherapy5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External beam RadiotherapyAlso: Hypofractionated External beam RadiotherapyFive 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 | Radiation | Hypofractionated External beam Radiotherapy |
Primary outcome
Evaluate acute radiation toxicity
Time frame: treatment to 12 weeks after completion of radiotherapy
Evaluate acute radiation toxicity according to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0). Acute toxicity is defined as treatment-related adverse events occurring within 12 weeks of completion of radiotherapy.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Puja S. Venkat, MD principal investigator
University of California at Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External beam Radiotherapy in people with Endometrial Cancer and Cervical Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christy Palodichuk (310-794-2971, cpalodichuk@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate acute radiation toxicity (time frame: treatment to 12 weeks after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.