New study: can proton therapy spare women from bowel problems after cancer surgery?
NCT ID NCT04567771
First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 4 times
Summary
This study compares two types of radiation therapy—proton therapy and standard intensity-modulated radiation therapy (IMRT)—given after surgery for cervical or endometrial cancer. The goal is to see if proton therapy causes fewer bowel side effects. About 120 women will fill out quality-of-life questionnaires and have their side effects tracked. The results could help doctors choose the gentler treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation therapy (proton or intensity-modulated)
- What this could lead to
- If proton therapy causes fewer bowel side effects than standard IMRT, it could become a gentler option for women after surgery for cervical or endometrial cancer.
- What could go wrong
- This is a small early-phase study (120 people) comparing side effects, not testing a cure. Results may not show a clear benefit, and individual experiences vary.
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
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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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About 121 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2020
- Expected to finish
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Apr 2029
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: * Histologically confirmed diagnosis of cervical or endometrial cancer * Must have undergone an open or robotic hysterectomy (total abdominal, vaginal, radical, or total laparoscopic) for carcinoma of the cervix or endometrium * History and physical prior to registration * Documentation of history of: * Smoking status * Pelvic infection * Pelvic inflammatory disease * Endometriosis * Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at any Mayo Clinic site * Plan for RT to pelvis with or without para-aortic lymph node irradiation * If received high-dose chemotherapy prior to registration, last dose must have been given \>= 21 days prior to start of RT * Complete blood count (CBC) performed within 21 days prior to registration * Computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET)/CT, or PET/MRI for staging before registration; may be pre-operative (op) or post-op * Eastern Cooperative Oncology Group (ECOG) performance score 0-2 * Provide written informed consent * Willing to complete quality of life (QOL) questionnaires Exclusion Criteria: * Receiving external beam boost dose during RT * Distant metastases * Gross disease at time of RT * Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas * Patients who exceed the weight/size limits of the treatment table * Positive or close surgical margins (=\< 3 mm) * Prior RT to the pelvis * Planned to receive inguinal node RT * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be immunosuppressive. * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years * Severe, active co-morbidity defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Other major medical illness which requires hospitalization or precludes study therapy at the time of registration * Patients unwilling to have rectal balloon placed on a daily basis during RT
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Arizona
ACTIVE_NOT_RECRUITINGScottsdale, Arizona, 85259, United States
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Mayo Clinic in Florida
ACTIVE_NOT_RECRUITINGJacksonville, Florida, 32224-9980, United States
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
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Other studies related to the condition(s) this trial covers.
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- Can pulsed radiation extend life in metastatic cervical cancer?
- Appendix: the hidden driver of endometriosis pain?
- Shorter, personalized radiation may target endometrial cancer with fewer side effects
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Allergy pill put to the test against endometriosis pain