CompletedNCT04458402Updated Dec 18, 2025

Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer

An interventional study of Hypofractionated WPRT in Endometrial Cancer, sponsored by Teresa Meier. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.

Sponsored by Teresa Meier · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was Jan 2025, 1 year 8 months ago, and no results have been posted to the registry.

Phase: Not applicable
Study type: Interventional
Enrollment: 8
Allocation: Not applicable
Ages: 18 Years and older
Sex: Female

Study summary

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 studied

Endometrial Cancer

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Endometrial Neoplasms 1,325

In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's enrollment of 8 is below the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

This is the only study on the registry with Teresa Meier as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 8 participants (actual)

Study arms

Experimental
Hypofractionated Whole-Pelvis Radiotherapy
Hypofractionated WPRT Cohort 1: 41.25 Gy in 15 fx Cohort 2: 38 Gy in 10 fx
Radiation: Hypofractionated WPRT

Interventions

RadiationHypofractionated WPRT
Cohort 1: 41.25 Gy in 15 fx Cohort 1: 38 Gy in 10 fx

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 3 months

Secondary outcomes

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.
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.
Patient compliance with radiotherapy will be recorded and used for exploratory analysis only.
Time frame: 3 months

Study locations

1 site

University of Cincinnati Medical Center
Cincinnati, Ohio 45219, United States

References and documents

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 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04458402
Lead sponsor: Teresa Meier
Responsible party: Teresa Meier (Principal Investigator, University of Cincinnati) — Sponsor-investigator
First posted: Jul 7, 2020
Start date: Feb 4, 2021
Primary completion: Jan 30, 2025
Completion: Apr 17, 2025
Last update: Dec 18, 2025

Study contacts

Teresa Meier, MD

principal investigator · University of Cincinnati

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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