Compares two radiation types after surgery for uterine or cervical cancer
Compares side effects of proton and standard radiation in adults with uterine or cervical cancer.
Plain-language title generated from the registry record
Registry title: Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
Key facts
- Where
- Jacksonville, Rochester, and Scottsdale, United StatesSee the 3 sites
Where in United States
- Mayo Clinic in FloridaJacksonville, United StatesNo longer taking part
- Mayo Clinic in RochesterRochester, United StatesTaking people
- Mayo Clinic in ArizonaScottsdale, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mayo Clinic
- Trial code
- NCT04567771
- Record updated
- 19 August 2026
- Original description
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.Read full original descriptionShow less
A Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers
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.
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; Positive or close surgical margins (=< 3 mm); Prior RT to the pelvis; 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; 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.