Endometrial CancerADAPT-ECNCT07643012
Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer
A study testing MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) in people with Endometrial Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
To evaluate the safety, tolerability, and preliminary efficacy of moderately hypofractionated (15-fraction) MR-guided adaptive pelvic IMRT in patients with endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2026to Jun 2029
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed endometrial carcinoma (endometrioid, serous, clear cell, carcinosarcoma, or dedifferentiated histology).
- Indication for adjuvant pelvic radiotherapy (± vaginal brachytherapy) for HIR defined by the ASTRO guidelines and GOG-99(7, 9) :
- Age
- High-grade histology (grade 2-3)
- Depth of myometrial invasion
- LVSI
Show all 13Show fewer
- Positive pelvic nodes
- Cervical stromal invasion
- Presence of poor prognostic molecular markers
- Age ≥18 years.
- Ability to provide informed consent.
- Eligible to receive adjuvant systemic therapy, if indicated, with a minimum 3-week interval between chemotherapy and radiotherapy.
- Willing and able to complete EORTC QLQ-C30 and EN-24 questionnaires in a validated language version.
Who cannot join
- Prior pelvic radiotherapy.
- Contraindication to pelvic radiotherapy (e.g., active connective tissue disorder or inflammatory bowel disease).
- Presence of a hip prosthesis that would compromise treatment planning or delivery.
- -
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
Rutgers Cancer Institut Jersey
New Brunswick, New Jersey, 08901
Lara Hathout
About this study
Official title: Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer: A Phase I/II Feasibility Study
To evaluate the safety, tolerability, and preliminary efficacy of moderately hypofractionated (15-fraction) MR-guided adaptive pelvic IMRT in patients with endometrial cancer.
Read the detailed description
The purpose of this research study is to evaluate a new way of delivering radiation therapy for patients with endometrial cancer. This study will test a shorter course of radiation treatment using magnetic resonance (MR)-guided technology, which allows for more precise targeting of treatment areas. The goal is to determine whether this approach is safe, well-tolerated, and effective, while potentially reducing side effects and the overall time required for treatment. If you take part in the research, you will receive radiation therapy using MR-guided imaging. This involves daily radiation treatments that may be adjusted based on imaging taken at each session (called adaptive radiotherapy). This approach is considered investigational because it is not yet a standard treatment for endometrial cancer. Your time in the research will take Your participation in the study will involve approximately 15 treatment sessions over about 3 weeks. Each session may take longer than standard radiation treatments due to the imaging and treatment planning performed on the same day.The purpose of this research study is to evaluate a new method of delivering radiation therapy for patients with endometrial cancer. This study will test a shorter course of radiation treatment using magnetic resonance (MR)-guided technology, which allows for more precise targeting of the treatment areas. The goal is to determine whether this approach is safe, well-tolerated, and effective, while potentially reducing side effects and the overall time required for treatment.
If you participate in this research, you will receive radiation therapy guided by MR imaging. This will involve daily radiation treatments that may be adjusted based on imaging taken at each session (known as adaptive radiotherapy). This approach is considered investigational as it is not yet a standard treatment for endometrial cancer.
Your participation in the study will involve approximately 15 treatment sessions over about 3 weeks. Each session may take longer than standard radiation treatments because imaging and treatment planning are performed on the same day.
- Conditions
- Endometrial Cancer
- Being tested
- MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT)
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT)Radiation
Participants receive moderately hypofractionated MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) delivered via MR-linac to a total dose of 42 Gy in 15 fractions with daily onboard MRI guidance and online adaptive replanning as needed to optimize target coverage and minimize radiation exposure to surrounding organs at risk.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: MR-guided Adaptive Pelvic IMRT | Experimental | Participants receive moderately hypofractionated MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) delivered via MR-linac to a total dose of 42 Gy in 15 fractions with daily onboard MRI and online adaptive replanning as needed to optimize target coverage and minimize radiation exposure to surrounding organs at risk. Vaginal brachytherapy may be administered following IMRT at the treating physician's discretion per institutional standards. Receives: Radiation: MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Grade ≥2 Gastrointestinal and Genitourinary Toxicity
Defined as the number and proportion of participants experiencing grade ≥2 acute gastrointestinal or genitourinary treatment-related adverse events occurring within 90 days after completion of MR-guided adaptive pelvic IMRT, as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, a standardized grading system for adverse events ranging from Grade 1 (mild) to Grade 5 (death related to adverse event)
Measured: Within 90 days after completion of treatment
Secondary outcomes (3)
Patient-Reported Quality of Life
Assessed using the EORTC QLQ-C30 to evaluate quality of life and symptom burden over time.
Measured: Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
Patient Reported Quality of Life
Description: Assessed using the EN-24 questionnaire to evaluate quality of life and symptom burden over time.
Measured: Time Frame: Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
Disease-Free Survival
Disease-free survival will be measured as the time from completion of MR-guided adaptive pelvic IMRT to the first documented recurrence or death from any cause, whichever occurs first. Recurrence will be assessed by clinical evaluation and/or imaging according to institutional standards. Participants without recurrence or death will be censored at the date of last disease assessment.
Measured: Up to 2 years after completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start9 Jun 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (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 Rutgers, The State University of New JerseyThe 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
- This is a prospective, single-arm, multi-center phase II pilot study within the RWJBarnabas Health system evaluating MR-guided IMRT, 30 Gy in 5 fractions, in patients with high-risk endometrial cancer. The study will enroll 30 patients to assess safety, feasibility, and preliminary efficacy of MR-linac-delivered SBRT.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Hathout, MD, FRCPC, Rutgers, The State University of New Jersey
- Investigators
- Lara M Hathout, Principal investigator, Rutgers University - Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643012
- Sponsor's protocol ID
- 152601
- Acronym
- ADAPT-EC
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer: A Phase I/II Feasibility Study
- ClinicalTrials.gov ID
- NCT07643012
- Acronym / sponsor ID
- ADAPT-EC / 152601
- Conditions
- Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 11 Jun 2026 (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.
To evaluate the safety, tolerability, and preliminary efficacy of moderately hypofractionated (15-fraction) MR-guided adaptive pelvic IMRT in patients with endometrial cancer.
Detailed description
The purpose of this research study is to evaluate a new way of delivering radiation therapy for patients with endometrial cancer. This study will test a shorter course of radiation treatment using magnetic resonance (MR)-guided technology, which allows for more precise targeting of treatment areas. The goal is to determine whether this approach is safe, well-tolerated, and effective, while potentially reducing side effects and the overall time required for treatment. If you take part in the research, you will receive radiation therapy using MR-guided imaging. This involves daily radiation treatments that may be adjusted based on imaging taken at each session (called adaptive radiotherapy). This approach is considered investigational because it is not yet a standard treatment for endometrial cancer. Your time in the research will take Your participation in the study will involve approximately 15 treatment sessions over about 3 weeks. Each session may take longer than standard radiation treatments due to the imaging and treatment planning performed on the same day.The purpose of this research study is to evaluate a new method of delivering radiation therapy for patients with endometrial cancer. This study will test a shorter course of radiation treatment using magnetic resonance (MR)-guided technology, which allows for more precise targeting of the treatment areas. The goal is to determine whether this approach is safe, well-tolerated, and effective, while potentially reducing side effects and the overall time required for treatment.
If you participate in this research, you will receive radiation therapy guided by MR imaging. This will involve daily radiation treatments that may be adjusted based on imaging taken at each session (known as adaptive radiotherapy). This approach is considered investigational as it is not yet a standard treatment for endometrial cancer.
Your participation in the study will involve approximately 15 treatment sessions over about 3 weeks. Each session may take longer than standard radiation treatments because imaging and treatment planning are performed on the same day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, multi-center phase II pilot study within the RWJBarnabas Health system evaluating MR-guided IMRT, 30 Gy in 5 fractions, in patients with high-risk endometrial cancer. The study will enroll 30 patients to assess safety, feasibility, and preliminary efficacy of MR-linac-delivered SBRT.
| Arm | Type | Receives |
|---|---|---|
| Experimental: MR-guided Adaptive Pelvic IMRT | Experimental | Radiation: MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT)Participants receive moderately hypofractionated MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) delivered via MR-linac to a total dose of 42 Gy in 15 fractions with daily onboard MRI and online adaptive replanning as needed to optimize target coverage and minimize radiation exposure to surrounding organs at risk. Vaginal brachytherapy may be administered following IMRT at the treating physician's discretion per institutional standards. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed endometrial carcinoma (endometrioid, serous, clear cell, carcinosarcoma, or dedifferentiated histology).
- Indication for adjuvant pelvic radiotherapy (± vaginal brachytherapy) for HIR defined by the ASTRO guidelines and GOG-99(7, 9) :
- Age
- High-grade histology (grade 2-3)
- Depth of myometrial invasion
Key exclusion criteria (4 listed)
- Prior pelvic radiotherapy.
- Contraindication to pelvic radiotherapy (e.g., active connective tissue disorder or inflammatory bowel disease).
- Presence of a hip prosthesis that would compromise treatment planning or delivery.
- -
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 |
|---|---|---|
| MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT)Participants receive moderately hypofractionated MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) delivered via MR-linac to a total dose of 42 Gy in 15 fractions with daily onboard MRI guidance and online adaptive replanning as needed to optimize target coverage and minimize radiation exposure to surrounding organs at risk. | Radiation | Experimental: MR-guided Adaptive Pelvic IMRT |
Primary outcome
Incidence of Acute Grade ≥2 Gastrointestinal and Genitourinary Toxicity
Time frame: Within 90 days after completion of treatment
Defined as the number and proportion of participants experiencing grade ≥2 acute gastrointestinal or genitourinary treatment-related adverse events occurring within 90 days after completion of MR-guided adaptive pelvic IMRT, as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, a standardized grading system for adverse events ranging from Grade 1 (mild) to Grade 5 (death related to adverse event)
3 secondary outcomes
Patient-Reported Quality of Life
Time frame: Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
Patient Reported Quality of Life
Time frame: Time Frame: Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
Disease-Free Survival
Time frame: Up to 2 years after completion of treatment.
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 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Lara M Hathout principal investigator
Rutgers University - Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) in people with Endometrial Cancer, run by Rutgers, The State University of New Jersey 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 13 inclusion and 4 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 6 Jul 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 Lara Hathout, MD (732-235-2465, Lh547@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Acute Grade ≥2 Gastrointestinal and Genitourinary Toxicity (time frame: Within 90 days after completion of treatment). 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 6 Jul 2026.