RecruitingPhase 1Phase 2NCT04683653

Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer

RT-PACE: Phase I/II Study of Adjuvant Whole Pelvic Hypofractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer


Sponsor

University of Chicago

Enrollment

100 participants

Start Date

Jan 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study will investigate if a shorter treatment course (known as "hypofractionation") for pelvic radiation is safe for women with endometrial cancer. Doctors leading the study will also determine the safest and most tolerable dose of shortened radiation (hypofractionation) used to treat women in this study. Because this study will shorten the radiation course typically used to treat endometrial cancer, each daily treatment given to women in this study will be slightly higher than normal to ensure that the total radiation dose they receive is still effective and similar to the radiation dose they would receive if they were not participating in this study (standard treatment).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a shorter, more intense radiation schedule (hypofractionation) to the pelvis in women who have had surgery for uterine or cervical cancer, to see if fewer, larger doses of radiation are just as effective as the standard longer course — with potentially fewer side effects. **You may be eligible if...** - You are 18 or older - You have been diagnosed with uterine or cervical cancer of any type - Your cancer has not spread to distant parts of the body - You had a hysterectomy with the goal of cure and no visible cancer remains after surgery - Your doctor recommends whole-pelvis radiation without concurrent chemotherapy or extended-field radiation - You are in reasonably good physical condition (ECOG ≤ 2) **You may NOT be eligible if...** - Your cancer has spread beyond the pelvis (metastatic) - You require concurrent chemotherapy with the radiation or radiation to extended fields beyond the pelvis 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

RADIATIONHypofractionated Radiation

Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given less often. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.

OTHERClinical Follow-Up and Assessments

At each visit, the subject will be evaluated for any signs of their endometrial cancer or symptoms returning (clinical disease recurrence) and any negative side effects associated with their prior radiation treatment. Study participants will also be asked to fill out a survey regarding bowel/urinary habits and quality of life questionnaires (known as the "EPIC questionnaire") during these visits. The data collected during these clinical follow up visits will be used to determine how effective hypofractionated/shortened whole radiation therapy is for treating endometrial cancer.


Locations(5)

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

University of Illinois at Chicago (UIC)

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

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NCT04683653


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