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

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.

Conditions

Cervical Carcinoma, Endometrial Carcinoma, Endometriosis, Pelvic Inflammatory Disease

Study Overview

Study Details

Study overview

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.

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

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

Condition
Cervical Carcinoma
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic in Arizona, Scottsdale, Arizona, United States, 85259

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224-9980

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 an Institutional Review Board (IRB)-approved 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

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

Study Record Dates

2025-10-15