Brief Title
Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer
Official Title
Phase I Study of Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer.
Brief Summary
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 Type
Interventional
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.
Secondary Outcome
Impact of hypofractionated WPRT on patient quality of life using the Functional Assessment of Cancer Therapy-Endometrial version 4.0.
Condition
Endometrial Cancer
Intervention
Hypofractionated WPRT
Study Arms / Comparison Groups
Hypofractionated Whole-Pelvis Radiotherapy
Description: Hypofractionated WPRT Cohort 1: 41.25 Gy in 15 fx Cohort 2: 38 Gy in 10 fx
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
15
Start Date
February 4, 2021
Completion Date
July 4, 2025
Primary Completion Date
February 4, 2024
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Teresa Meier, MD, 513-584-7698, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04458402
Organization ID
UCCC-GYN-20-01
Responsible Party
Sponsor-Investigator
Study Sponsor
Teresa Meier
Study Sponsor
Teresa Meier, MD, Principal Investigator, University of Cincinnati
Verification Date
February 2021