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NCT04567771Recruiting

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

A Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers

Source: ClinicalTrials.gov · Last updated 19 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
121 (estimated)
First submitted
23 Sept 2020
Start date
4 Dec 2020
Primary completion date
1 Apr 2029
Lead sponsor
Mayo Clinic
NCT number
NCT04567771

What you commit to

  • Study type: Interventional
  • Planned participants: 121
  • From 4 Dec 2020 to the primary completion date, 1 Apr 2029
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving external beam boost dose during RT
  • Positive or close surgical margins (=\< 3 mm)
  • Prior RT to the pelvis

Other illness

  • Gross disease at time of 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

Other

  • Distant metastases
  • Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas
  • Patients who exceed the weight/size limits of the treatment table
  • Planned to receive inguinal node RT
  • Patients unwilling to have rectal balloon placed on a daily basis during RT

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic in Florida
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesActive, not recruiting
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
Mayo Clinic in Arizona
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.