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

Running, not enrolling · Not applicable

Conditions studied: Cervical Carcinoma, Endometrial Carcinoma, Endometriosis, Pelvic Inflammatory Disease

In brief

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.

Key facts

Study ID

NCT04567771

Run by

Mayo Clinic

People needed

121

Starts

2020-12-04

Expected to finish

2029-04-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.