RecruitingNot ApplicableNCT04567771

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


Sponsor

Mayo Clinic

Enrollment

120 participants

Start Date

Dec 4, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of radiation therapy — proton therapy and intensity-modulated radiation therapy (IMRT) — for women who have had surgery for cervical or endometrial cancer and need radiation to reduce the risk of recurrence. The goal is to find out which approach causes fewer side effects. **You may be eligible if...** - You have been diagnosed with cervical or endometrial cancer confirmed by biopsy - You have already had a hysterectomy (surgical removal of the uterus) - You are planned to receive radiation therapy to the pelvis at a Mayo Clinic site - You are in good enough health to receive radiation (ECOG 0-2) - You are willing to complete quality-of-life questionnaires **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body - You have residual visible cancer remaining after surgery - You have had previous radiation to the pelvis - You have HIV/AIDS, severe liver disease, or a recent serious heart condition (heart attack or hospitalization for heart failure in the past 6 months) - Your tumor has a specific rare cell type (endometrial stromal sarcoma, leiomyosarcoma, melanoma, or small cell carcinoma) - You have had a prior invasive cancer in the last 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERQuality-of-Life Assessment

Complete quality of life questionnaires

OTHERQuestionnaire Administration

Complete adverse event assessments

RADIATIONRadiation Therapy

Undergo proton or intensity modulated radiation therapy


Locations(3)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT04567771


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