NCT04683653 Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer
| NCT ID | NCT04683653 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Chicago |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-01-15 |
| Primary Completion | 2027-05-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2021-01-15 with a primary completion date of 2027-05-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Christina Son, MD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT04683653 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04683653 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04683653 currently recruiting?
Yes, NCT04683653 is actively recruiting participants. Contact the research team at cancerclinicaltrials@bsd.uchicago.edu for enrollment information.
Where is the NCT04683653 trial being conducted?
This trial is being conducted at Atlanta, United States, Chicago, United States, Chicago, United States, Houston, United States and 1 additional location.
Who is sponsoring the NCT04683653 clinical trial?
NCT04683653 is sponsored by University of Chicago. The principal investigator is Christina Son, MD at University of Chicago. The trial plans to enroll 100 participants.
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