A Study to Compare Acute Toxicities between Patients Treated with Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers

Overview

About this study

The purpose of this study is to evaluate whether proton radiation therapy (proton RT) reduces acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years old.
  • 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 Intensity-Modulated Radiation Therapy (IMRT) radiation treatment, with use of rectal balloon, at an IRB-approved Mayo Clinic site.
  • Plan for radiation therapy (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 .       
  • CBC performed within 21 days prior to registration.
  • CT, MRI, PET/CT, or PET/MRI for staging before registration; may be pre-op or post-op.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2.
  • Provide written informed consent.
  • Willing to complete QOL questionnaires.

Exclusion Criteria: 

  • Receiving external beam boost dose during RT.
  • Distant metastases.
  • No 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.
  • Patients with active irritable bowel disease.
  • 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 CDC definition; note that 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ivy Petersen, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Katherine Tzou, M.D.

Open for enrollment

Contact information:

Kayla Rodriguez

(904) 953-3588

Rodriguez.Kayla1@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Sujay Vora, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20503346

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