Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer

Launched by UNIVERSITY OF CHICAGO · Dec 21, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to give radiation treatment for women with endometrial cancer, which is cancer that starts in the lining of the uterus. The researchers want to see if giving a higher dose of radiation over a shorter period—called "hypofractionation"—is safe and effective. Typically, radiation treatment takes several weeks, but this study aims to reduce that time while ensuring that the total amount of radiation remains the same as the standard treatment.

To participate in this trial, women should be at least 18 years old and have been diagnosed with non-metastatic endometrial cancer, meaning the cancer has not spread to other parts of the body. They should have had surgery to remove the cancer without any remaining visible cancer cells. Participants will receive whole pelvic radiation without chemotherapy during the study. If you or a loved one is interested in this trial, it's important to discuss with a healthcare provider to see if you meet the eligibility criteria and to understand what to expect during the treatment.

Gender

FEMALE

Eligibility criteria

• 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.