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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of primary cervical cancer or uterine cancer of any histology - Age ≥ 18 years. - Non-metastatic 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. - Eastern Cooperative Oncology Group (ECOG) PS≤ 2 - Able to provide informed consent and willingness to sign an approved consent form

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 grade 2 or higher chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation. - Recommendation to undergo para-aortic nodal irradiation.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Hypofractionated Radiation Treatment (Dose-Finding Arm) 		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).
  • Radiation: Hypofractionated Radiation
    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.
Experimental
Expansion Cohort (Efficacy Arm) 		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.
  • Other: Clinical Follow-Up and Assessments
    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.

Recruiting Locations

University of Illinois at Chicago (UIC)
Chicago, Illinois 60612
Contact:
Mercedes Carrasquillo
312-413-1902
micarras@uic.edu

University of Chicago
Chicago, Illinois 60637
Contact:
Cancer Intake
855-702-8222
cancerclinicaltrials@bsd.uchicago.edu

MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Rauda Alicia Cordova
713-563-8466
racordova@mdanderson.org

Huntsman Cancer Institute
Salt Lake City, Utah 84112
Contact:
Rachel Kingsford
801-585-0115
rachel.kingsford@hci.utah.edu

More Details

Status
Recruiting
Sponsor
University of Chicago

Study Contact

Christina Son, MD
773-702-6870
cancerclinicaltrials@bsd.uchicago.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.