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New study: can proton therapy spare women from bowel problems after cancer surgery?

NCT ID NCT04567771

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

About 121 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Apr 2029

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: * 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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Arizona

    ACTIVE_NOT_RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic in Florida

    ACTIVE_NOT_RECRUITING

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

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