Can fewer, stronger radiation doses spare the bowel in gynecologic cancers?

NCT ID NCT05139368

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

22 people

The number who actually took part.

Started

Nov 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

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