Endometrial Cancer study: Hypofractionated Radiation
Official title Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer
ClinicalTrials.gov ID: NCT04683653
What this study is testing
- What it's testing
- The study tests whether a shorter, higher‑dose radiation schedule is safe and tolerable for women with endometrial cancer.
- Who it's for
- Women who have been diagnosed with endometrial cancer and are eligible for pelvic radiation.
- What's involved
- Participants receive daily radiation treatments that are slightly higher than usual, but the total dose is kept similar to standard therapy. Doctors monitor safety and tolerance during the course.
- Time commitment
- The treatment lasts a few weeks, with daily visits for radiation and regular follow‑up appointments to check safety and side effects.
- 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.
- Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation.
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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Chicago, Illinois, United States; Houston, Texas, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.