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New treatment option for Endometrial Cancer
Official title Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer
ClinicalTrials.gov ID: NCT04683653
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. Chemotherapy before or after radiotherapy...
You likely can't join if
- 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...
- History of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical...
- 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.
See the full eligibility 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Chicago, Illinois, United States; Houston, Texas, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.