Status:
RECRUITING
Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer
Lead Sponsor:
University of Chicago
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 22 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04683653
Start Date
January 15 2021
End Date
May 22 2027
Last Update
December 29 2025
Active Locations (5)
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1
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
2
University of Illinois at Chicago (UIC)
Chicago, Illinois, United States, 60612
3
University of Chicago
Chicago, Illinois, United States, 60637
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030