Endometrial CancerNCT04458402
Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer
A study testing Hypofractionated WPRT in people with Endometrial Cancer, run by Teresa Meier at 1 site in United States.
Trial summary
Studying adjuvant hypofractionated whole pelvis radiation therapy in Endometrial Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Hypofractionated WPRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2021to 17 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients with histologically confirmed stage I, II, or III endometrial cancer who require pelvic radiation as determined by their treating radiation oncologist and/or gynecologic oncologist. Patients may also be identified through the Gynecologic Oncology Multidisciplinary Tumor Board. The decision to include Stage I patients will be based on risk factors for recurrence including tumor grade, extent of myometrial invasion, presence of lymphovascular space invasion, and histology (endometrioid, papillary serous, clear cell, carcinosarcoma). Stage I patients may include those who are ineligible for vaginal cuff brachytherapy due to patient anatomy or those who are at higher risk for pelvic nodal recurrence and pelvic external beam radiotherapy is preferred over vaginal cuff brachytherapy.
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%).
- Patients must have undergone total hysterectomy and bilateral salpingo-oophorectomy with or without pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node (SLN) dissection.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with an Inflammatory Bowel Disease diagnosis, regardless of disease activity.
- Patients with current, active disease involving periaortic node(s). This is based on histologically positive para-aortic node(s) removed at time of surgery.
- Patients with gross residual disease following surgical resection. Final pathologic margins must be negative (no tumor on ink). This may also be determined clinically by the gynecologic oncologist at time of surgery or post-operative imaging if applicable. Post-operative imaging is not required at time of surgery.
- Patients who have ever had pelvic radiotherapy prior to entering the study.
- Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.
- Patients with uncontrolled intercurrent illness.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
About this study
Official title: Phase I Study of Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer.
Studying adjuvant hypofractionated whole pelvis radiation therapy in Endometrial Cancer.
Read the detailed description
This is a Phase I study evaluating the safety of adjuvant hypofractionated whole pelvis radiation therapy (WPRT) in endometrial cancer. The primary objective of the study is to determine the maximum tolerated dose per fraction (MTDF), defined by acceptable acute clinician-reported GI and GU toxicity and patient-reported GI toxicity, of WPRT from among the two study dose levels. Acute GI and GU toxicity will be assessed according to both the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0, and Patient Reported Outcome-CTCAE (PRO-CTCAE). Clinician-reported dose-limiting toxicity (C-DLT) is a binary outcome (yes/no), defined as an acute grade 3 or higher GI or GU per CTCAE, occurring within three months of completing WPRT. Patient-reported DLT (P-DLT) is a binary outcome, defined by a GI toxicity with a score of ≥4 on the 5-point scale per PRO-CTCAE, occurring within three months of completing WPRT. The MTDF is defined as the minimum of the dose with a C-DLT rate closest to the clinician-reported target C-DLT rate of 20% and the dose with a P-DLT rate closest to the patient-reported target P-DLT rate of 55%. Toxicity results of NRG-RTOG 1203- A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer- were used to define the acceptable percentage of DLTs. The study will accrue participants in cohorts of size 3. The starting dose level will be dose level 1 (41.25 Gy in 15 fx).
- Conditions
- Endometrial Cancer
- Being tested
- Hypofractionated WPRT
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated WPRTRadiation
Cohort 1: 41.25 Gy in 15 fx Cohort 1: 38 Gy in 10 fx
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Whole-Pelvis Radiotherapy | Experimental | Hypofractionated WPRT Cohort 1: 41.25 Gy in 15 fx Cohort 2: 38 Gy in 10 fx Receives: Radiation: Hypofractionated WPRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of hypofractionated, isoeffective whole pelvis radiation regimens for post-operative treatment of endometrial cancer using CTCAE version 5.0 and Patient Reported Outcome-CTCAE.
Toxicity profile will be determined by assessment of acute gastrointestinal and genitourinary toxicity during WPRT and 3 months post-radiation using CTCAE version 5.0 and Patient Reported Outcome-CTCAE (PRO-CTCAE). Dose-limiting toxicity (DLT) will be defined as any acute ≥ grade 3 gastrointestinal or genitourinary per CTCAE or a score of ≥4 on the 5-point scale per PRO-CTCAE.
Measured: 3 months
Maximum tolerated dose per fraction (MTDF) of hypofractionated, isoeffective whole pelvis radiation regimens for post-operative treatment of endometrial cancer through CTCAE data and gastrointestinal PRO-CTCAE data.
Determination of the MTDF will rely on toxicity data, specifically combined gastrointestinal and genitourinary CTCAE data and gastrointestinal PRO-CTCAE data. MTDF should not exceed >20% of patients having a DLT per CTCAE or >55% of patients having a dose-limiting GI toxicity per PRO-CTCAE. Further details in study design.
Measured: 3 months
Secondary outcomes (2)
Impact of hypofractionated WPRT on patient quality of life using the Functional Assessment of Cancer Therapy-Endometrial version 4.0.
Quality of life data will be obtained for exploratory analysis only.
Measured: 3 months
Patient compliance with hypofractionated WPRT, as defined by how many patients are able to complete WPRT without a break in treatment.
Patient compliance with radiotherapy will be recorded and used for exploratory analysis only.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start4 Feb 2021
- Primary completion30 Jan 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- Dose allocation will be based upon a Bayesian continual reassessment method that incorporates patient-reported outcomes (PRO-CRM17), which uses separate models for the probability of C-DLT and the probability of P-DLT, as well as the accumulated C-DLT and P-DLT data at each dose level, to sequentially allocate each new patient cohort.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teresa Meier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Teresa Meier, University of Cincinnati
- Investigators
- Teresa Meier, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458402
- Sponsor's protocol ID
- UCCC-GYN-20-01
- Status last verified
- Dec 2025
- First submitted
- 1 Jul 2020
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wages NA, Nelson B, Kharofa J, Meier T. Application of the patient-reported outcomes continual reassessment method to a phase I study of radiotherapy in endometrial cancer. Int J Biostat. 2022 Nov 17;19(1):163-176. doi: 10.1515/ijb-2022-0023. eCollection 2023 May 1.
PubMed 36394530
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer.
- ClinicalTrials.gov ID
- NCT04458402
- Acronym / sponsor ID
- UCCC-GYN-20-01
- Conditions
- Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Teresa MeierUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 7 Jul 2020 (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.
Studying adjuvant hypofractionated whole pelvis radiation therapy in Endometrial Cancer.
Detailed description
This is a Phase I study evaluating the safety of adjuvant hypofractionated whole pelvis radiation therapy (WPRT) in endometrial cancer. The primary objective of the study is to determine the maximum tolerated dose per fraction (MTDF), defined by acceptable acute clinician-reported GI and GU toxicity and patient-reported GI toxicity, of WPRT from among the two study dose levels. Acute GI and GU toxicity will be assessed according to both the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0, and Patient Reported Outcome-CTCAE (PRO-CTCAE). Clinician-reported dose-limiting toxicity (C-DLT) is a binary outcome (yes/no), defined as an acute grade 3 or higher GI or GU per CTCAE, occurring within three months of completing WPRT. Patient-reported DLT (P-DLT) is a binary outcome, defined by a GI toxicity with a score of ≥4 on the 5-point scale per PRO-CTCAE, occurring within three months of completing WPRT. The MTDF is defined as the minimum of the dose with a C-DLT rate closest to the clinician-reported target C-DLT rate of 20% and the dose with a P-DLT rate closest to the patient-reported target P-DLT rate of 55%. Toxicity results of NRG-RTOG 1203- A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer- were used to define the acceptable percentage of DLTs. The study will accrue participants in cohorts of size 3. The starting dose level will be dose level 1 (41.25 Gy in 15 fx).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose allocation will be based upon a Bayesian continual reassessment method that incorporates patient-reported outcomes (PRO-CRM17), which uses separate models for the probability of C-DLT and the probability of P-DLT, as well as the accumulated C-DLT and P-DLT data at each dose level, to sequentially allocate each new patient cohort.
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Whole-Pelvis Radiotherapy | Experimental | Radiation: Hypofractionated WPRTHypofractionated WPRT Cohort 1: 41.25 Gy in 15 fx Cohort 2: 38 Gy in 10 fx |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically confirmed stage I, II, or III endometrial cancer who require pelvic radiation as determined by their treating radiation oncologist and/or gynecologic oncologist. Patients may also be identified through the Gynecologic Oncology Multidisciplinary Tumor Board. The decision to include Stage I patients will be based on risk factors for recurrence including tumor grade, extent of myometrial invasion, presence of lymphovascular space invasion, and histology (endometrioid, papillary serous, clear cell, carcinosarcoma). Stage I patients may include those who are ineligible for vaginal cuff brachytherapy due to patient anatomy or those who are at higher risk for pelvic nodal recurrence and pelvic external beam radiotherapy is preferred over vaginal cuff brachytherapy.
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%).
- Patients must have undergone total hysterectomy and bilateral salpingo-oophorectomy with or without pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node (SLN) dissection.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Key exclusion criteria (7 listed)
- Patients with an Inflammatory Bowel Disease diagnosis, regardless of disease activity.
- Patients with current, active disease involving periaortic node(s). This is based on histologically positive para-aortic node(s) removed at time of surgery.
- Patients with gross residual disease following surgical resection. Final pathologic margins must be negative (no tumor on ink). This may also be determined clinically by the gynecologic oncologist at time of surgery or post-operative imaging if applicable. Post-operative imaging is not required at time of surgery.
- Patients who have ever had pelvic radiotherapy prior to entering the study.
- Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.
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 |
|---|---|---|
| Hypofractionated WPRTCohort 1: 41.25 Gy in 15 fx Cohort 1: 38 Gy in 10 fx | Radiation | Hypofractionated Whole-Pelvis Radiotherapy |
Primary outcome
Safety profile of hypofractionated, isoeffective whole pelvis radiation regimens for post-operative treatment of endometrial cancer using CTCAE version 5.0 and Patient Reported Outcome-CTCAE.
Time frame: 3 months
Toxicity profile will be determined by assessment of acute gastrointestinal and genitourinary toxicity during WPRT and 3 months post-radiation using CTCAE version 5.0 and Patient Reported Outcome-CTCAE (PRO-CTCAE). Dose-limiting toxicity (DLT) will be defined as any acute ≥ grade 3 gastrointestinal or genitourinary per CTCAE or a score of ≥4 on the 5-point scale per PRO-CTCAE.
Maximum tolerated dose per fraction (MTDF) of hypofractionated, isoeffective whole pelvis radiation regimens for post-operative treatment of endometrial cancer through CTCAE data and gastrointestinal PRO-CTCAE data.
Time frame: 3 months
Determination of the MTDF will rely on toxicity data, specifically combined gastrointestinal and genitourinary CTCAE data and gastrointestinal PRO-CTCAE data. MTDF should not exceed >20% of patients having a DLT per CTCAE or >55% of patients having a dose-limiting GI toxicity per PRO-CTCAE. Further details in study design.
2 secondary outcomes
Impact of hypofractionated WPRT on patient quality of life using the Functional Assessment of Cancer Therapy-Endometrial version 4.0.
Time frame: 3 months
Patient compliance with hypofractionated WPRT, as defined by how many patients are able to complete WPRT without a break in treatment.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 36394530Wages NA, Nelson B, Kharofa J, Meier T. Application of the patient-reported outcomes continual reassessment method to a phase I study of radiotherapy in endometrial cancer. Int J Biostat. 2022 Nov 17;19(1):163-176. doi: 10.1515/ijb-2022-0023. eCollection 2023 May 1.
- 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. This study is not recruiting at the moment.
Teresa Meier, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated WPRT in people with Endometrial Cancer, run by Teresa Meier 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 18 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile of hypofractionated, isoeffective whole pelvis radiation regimens for post-operative treatment of endometrial cancer using CTCAE version 5.0 and Patient Reported Outcome-CTCAE. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04458402, which also lists 1 linked publication.
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 18 Dec 2025.