Recruiting

Proton & IMRT

Sponsor:

Mayo Clinic

Code:

NCT04567771

Conditions

Cervical Carcinoma

Endometrial Carcinoma

Endometriosis

Pelvic Inflammatory Disease

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quality-of-Life Assessment

Questionnaire Administration

Radiation Therapy

Study Details

Brief summary:

This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.

Conditions

Cervical Carcinoma

Endometrial Carcinoma

Endometriosis

Pelvic Inflammatory Disease

Study ID

NCT04567771

Start date

Dec 4, 2020

Status verified date

Jul, 2026

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Apr 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

121 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (radiation therapy, questionnaires)

Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.

Interventions

Quality-of-Life Assessment

Complete quality of life questionnaires

Questionnaire Administration

Complete adverse event assessments

Radiation Therapy

Undergo proton or intensity modulated radiation therapy

Primary outcome measure

  • Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score [ Time Frame: Baseline up to 3 years post-radiation therapy (RT) ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referra Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Allison E. Garda, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 19, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-19.