Back to resultsStudy of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer
Primary Purpose
Endometrial Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypofractionated Radiation
Clinical Follow-Up and Assessments
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of endometrial cancer with any of the following primary histologic types: endometrioid, papillary serous, clear cell, carcinosarcoma, or mixed epithelial histologies.
- Age ≥ 18 years.
- Must have been diagnosed with Stage I-III disease according to The International Federation of Gynecology and Obstetrics (FIGO).
- Must have been treated with definitive intent, including standard-of-care hysterectomy, without any gross residual disease post-operatively. Nodal dissection is not required, but if it is not performed, then diagnostic imaging to confirm absence of gross pelvic or para-aortic disease should be obtained pre- or post-operatively.
- Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. Chemotherapy before or after radiotherapy is acceptable.
Exclusion Criteria:
- Distant metastases as determined clinically or radiographically based upon standard-of-care work-up for endometrial cancer.
- Concurrent (or other) chemotherapy occurring at the time of study.
- Gross residual disease (cancer cells that remain after attempts to remove the cancer have been made) post-operatively and/or at the time of radiation based upon pre-op or post-op imaging, intra-operative findings, and gynecologic oncologists' judgment.
- History of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical management, or prior radiation therapy directed to the pelvis.
- Unresolved chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation.
- Recommendation to undergo para-aortic nodal irradiation.
Sites / Locations
- University of ChicagoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hypofractionated Radiation Treatment (Dose-Finding Arm)
Expansion Cohort (Efficacy Arm)
Arm Description
All study participants in this arm will receive hypofractionated whole pelvic radiation treatment for a shortened time period of 3-5 weeks. The goal of this arm is to establish a safe and tolerable dose of shortened (hypofractionated) pelvic radiation treatment for study participants. Once a safe and tolerable dose is established for this shortened form of radiation treatment, participants who meet criteria for the second phase of this study will participate in an expansion cohort that will explore the efficacy (how effective shortened/hypofractionated radiation treatment is for treating endometrial cancer).
Participants in this arm will test how effective hypofractionated/shortened whole radiation treatment is ("efficacy") at the dose established in the first phase of this study by following up with their doctors to report their current health status and symptoms during clinical visits. Participants will return for routine clinical follow-up approximately 1 month following radiation, then at 3 months following radiation, then every 3 months for the next 2 years following treatment.
Outcomes
Primary Outcome Measures
The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment
The maximum tolerated dose-per-fraction regimen of whole pelvic radiation therapy that will be administered during uterine cancer treatment.
Secondary Outcome Measures
Toxicity Determined by Reported Adverse Events for Hypofractionated Whole Pelvic Radiation Treatment
The acute toxicity profile of hypofractionated radiation therapy using CTCAE v5.0. CTCAE GU toxicity will be determined using the domains of urinary frequency, urinary incontinence, and urinary urgency (whichever is maximum). Time point of evaluation is on the last day of radiation.
Rate of Pelvic Control 2 Years Post Radiation
The rate of pelvic control at 2 years post-radiation using CTCAE v5.0 domains of diarrhea and proctitis (whichever is maximum). Study participants will follow for routine clinical follow-up approximately 1 month following radiation, then at 3 months following radiation, then every 3 months for the next 2 years following treatment. Each follow-up time period will be evaluated for CTCAE GI and GU maximum toxicity. Crude rates and cumulative incidence of pelvic failure will be calculated. Pelvic failure is defined as clinical or radiographic evidence of recurrent disease within the irradiated pelvis (pelvic lymph nodes, vaginal cuff, or parametria) as determined by the treating physician(s). Peritoneal metastases will not be considered a pelvic failure.
Full Information
NCT ID
NCT04683653
First Posted
December 21, 2020
Last Updated
August 25, 2023
Sponsor
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT04683653
Brief Title
Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer
Official Title
Phase I Safety Study of Whole Pelvic Hypofractionated Radiotherapy in Women With Endometrial Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
May 22, 2025 (Anticipated)
Study Completion Date
May 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate if a shorter treatment course (known as "hypofractionation") for pelvic radiation is safe for women with endometrial cancer. Doctors leading the study will also determine the safest and most tolerable dose of shortened radiation (hypofractionation) used to treat women in this study. Because this study will shorten the radiation course typically used to treat endometrial cancer, each daily treatment given to women in this study will be slightly higher than normal to ensure that the total radiation dose they receive is still effective and similar to the radiation dose they would receive if they were not participating in this study (standard treatment).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypofractionated Radiation Treatment (Dose-Finding Arm)
Arm Type
Experimental
Arm Description
All study participants in this arm will receive hypofractionated whole pelvic radiation treatment for a shortened time period of 3-5 weeks. The goal of this arm is to establish a safe and tolerable dose of shortened (hypofractionated) pelvic radiation treatment for study participants. Once a safe and tolerable dose is established for this shortened form of radiation treatment, participants who meet criteria for the second phase of this study will participate in an expansion cohort that will explore the efficacy (how effective shortened/hypofractionated radiation treatment is for treating endometrial cancer).
Arm Title
Expansion Cohort (Efficacy Arm)
Arm Type
Experimental
Arm Description
Participants in this arm will test how effective hypofractionated/shortened whole radiation treatment is ("efficacy") at the dose established in the first phase of this study by following up with their doctors to report their current health status and symptoms during clinical visits. Participants will return for routine clinical follow-up approximately 1 month following radiation, then at 3 months following radiation, then every 3 months for the next 2 years following treatment.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Radiation
Intervention Description
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given less often. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Intervention Type
Other
Intervention Name(s)
Clinical Follow-Up and Assessments
Intervention Description
At each visit, the subject will be evaluated for any signs of their endometrial cancer or symptoms returning (clinical disease recurrence) and any negative side effects associated with their prior radiation treatment. Study participants will also be asked to fill out a survey regarding bowel/urinary habits and quality of life questionnaires (known as the "EPIC questionnaire") during these visits. The data collected during these clinical follow up visits will be used to determine how effective hypofractionated/shortened whole radiation therapy is for treating endometrial cancer.
Primary Outcome Measure Information:
Title
The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment
Description
The maximum tolerated dose-per-fraction regimen of whole pelvic radiation therapy that will be administered during uterine cancer treatment.
Time Frame
3-5 weeks
Secondary Outcome Measure Information:
Title
Toxicity Determined by Reported Adverse Events for Hypofractionated Whole Pelvic Radiation Treatment
Description
The acute toxicity profile of hypofractionated radiation therapy using CTCAE v5.0. CTCAE GU toxicity will be determined using the domains of urinary frequency, urinary incontinence, and urinary urgency (whichever is maximum). Time point of evaluation is on the last day of radiation.
Time Frame
3-5 weeks.
Title
Rate of Pelvic Control 2 Years Post Radiation
Description
The rate of pelvic control at 2 years post-radiation using CTCAE v5.0 domains of diarrhea and proctitis (whichever is maximum). Study participants will follow for routine clinical follow-up approximately 1 month following radiation, then at 3 months following radiation, then every 3 months for the next 2 years following treatment. Each follow-up time period will be evaluated for CTCAE GI and GU maximum toxicity. Crude rates and cumulative incidence of pelvic failure will be calculated. Pelvic failure is defined as clinical or radiographic evidence of recurrent disease within the irradiated pelvis (pelvic lymph nodes, vaginal cuff, or parametria) as determined by the treating physician(s). Peritoneal metastases will not be considered a pelvic failure.
Time Frame
2 years after last dose of radiation treatment.
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of endometrial cancer with any of the following primary histologic types: endometrioid, papillary serous, clear cell, carcinosarcoma, or mixed epithelial histologies.
Age ≥ 18 years.
Must have been diagnosed with Stage I-III disease according to The International Federation of Gynecology and Obstetrics (FIGO).
Must have been treated with definitive intent, including standard-of-care hysterectomy, without any gross residual disease post-operatively. Nodal dissection is not required, but if it is not performed, then diagnostic imaging to confirm absence of gross pelvic or para-aortic disease should be obtained pre- or post-operatively.
Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. Chemotherapy before or after radiotherapy is acceptable.
Exclusion Criteria:
Distant metastases as determined clinically or radiographically based upon standard-of-care work-up for endometrial cancer.
Concurrent (or other) chemotherapy occurring at the time of study.
Gross residual disease (cancer cells that remain after attempts to remove the cancer have been made) post-operatively and/or at the time of radiation based upon pre-op or post-op imaging, intra-operative findings, and gynecologic oncologists' judgment.
History of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical management, or prior radiation therapy directed to the pelvis.
Unresolved chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation.
Recommendation to undergo para-aortic nodal irradiation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Son, MD
Phone
773-702-6870
Email
cancerclinicaltrials@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Son, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer Intake
Phone
855-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
12. IPD Sharing Statement
Learn more about this trial
Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer
We'll reach out to this number within 24 hrs