Can fewer, stronger radiation doses spare the bowel in gynecologic cancers?
NCT ID NCT05139368
First seen Sep 04, 2026 ยท Last updated Sep 04, 2026
Summary
This pilot study tests whether hypofractionated radiation therapy, which gives higher doses over fewer sessions, is a practical option for people with non-metastatic cervical or endometrial cancer after hysterectomy. Researchers will measure bowel and urinary side effects using patient questionnaires and track how many participants complete the treatment. The goal is to see if this shorter course can reduce side effects while keeping quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hypofractionated radiation therapy, which delivers higher doses of radiation over a shorter treatment period
- What this could lead to
- If this approach works, it could shorten radiation treatment for cervical and endometrial cancer while reducing bowel side effects and preserving quality of life.
- What could go wrong
- This is a small pilot study, so results may not apply broadly. The higher radiation doses could still cause side effects, and the trial only measures short-term changes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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22 people
The number who actually took part.
- Started
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Nov 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects aged \>= 18 years * Pathologically confirmed malignancy of the cervix or endometrium. Non-epithelial histologies are permitted. Adenocarcinoma in situ is also permitted * Patients must be status post hysterectomy for initial management of cervix or endometrial cancer * Subject must have non-metastatic disease as determined by clinical exam or computed tomography (CT) or positron emission tomography (PET)/CT imaging * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Recovery to baseline or =\< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines * Life expectancy of \> 2 years * Chemotherapy can be administered at discretion of the treating radiation, medical, or gynecologic oncologist. Sequential therapy (radiation followed by chemotherapy) is preferred but not required Exclusion Criteria: * Prior abdominal or pelvic irradiation * Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks, unless chemotherapy is administered prior to RT. If chemotherapy is administered prior to RT, consult with PI regarding acceptable time frame. * Prior history of inflammatory bowel disease * The diagnosis of another malignancy within =\< 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, or bladder or of the cervix) * Medical, psychiatric, cognitive, or other conditions in the opinion of the investigator that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
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