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Comparing Proton and IMRT Radiation After Surgery for Endometrial or Cervical Cancer

This study compares two types of radiation therapy, proton radiation therapy and intensity modulated radiation therapy (IMRT), given after surgery for endometrial or cervical cancer. Doctors want to see if proton radiation therapy causes fewer digestive side effects at the end of treatment. You would complete quality of life and side effect questionnaires. The study is looking for 121 women, aged 18 or older, who have been diagnosed with cervical or endometrial cancer and have had a hysterectomy. The main goal is to measure changes in bowel function up to three years after radiation therapy to see which treatment is better tolerated.

Study design
This interventional study plans to enroll 121 participants. It compares two different radiation therapies after surgery.
What's involved
You would undergo either proton or intensity modulated radiation therapy. You would also complete quality of life and adverse event questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Your bowel function will be measured from the start of the study up to 3 years after radiation therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04567771

Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer

Recruiting
NAAges 18+InterventionalTreatment
Mayo Clinic
~121 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Quality-of-Life AssessmentQuestionnaire AdministrationRadiation Therapy

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score
Measured over Baseline up to 3 years post-radiation therapy (RT)

Conditions

Cervical Carcinoma
Endometrial Carcinoma
Endometriosis
Pelvic Inflammatory Disease

Explore related trials

Cervical CarcinomaEndometrial Carcinoma

Where it's being run

3 sites across 3 states
Arizona1
Florida1
Minnesota1

Study leadership

  • Allison E. Garda, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel scoreBaseline up to 3 years post-radiation therapy (RT)

    Will be examined using analysis of covariance.