- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04458402
Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer
February 9, 2021 updated by: Teresa Meier
Phase I Study of Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer.
Studying adjuvant hypofractionated whole pelvis radiation therapy in Endometrial Cancer.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Teresa Meier, MD
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- Recruiting
- University of Cincinnati Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Hypofractionated Whole-Pelvis Radiotherapy
Hypofractionated WPRT Cohort 1: 41.25 Gy in 15 fx Cohort 2: 38 Gy in 10 fx
|
Cohort 1: 41.25 Gy in 15 fx Cohort 1: 38 Gy in 10 fx
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of hypofractionated WPRT on patient quality of life using the Functional Assessment of Cancer Therapy-Endometrial version 4.0.
Time Frame: 3 months
|
Quality of life data will be obtained for exploratory analysis only.
|
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
|
Patient compliance with radiotherapy will be recorded and used for exploratory analysis only.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Teresa Meier, MD, University of Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 4, 2021
Primary Completion (ANTICIPATED)
February 4, 2024
Study Completion (ANTICIPATED)
July 4, 2025
Study Registration Dates
First Submitted
July 1, 2020
First Submitted That Met QC Criteria
July 1, 2020
First Posted (ACTUAL)
July 7, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 12, 2021
Last Update Submitted That Met QC Criteria
February 9, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCCC-GYN-20-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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