RT-PACE: Phase I/II Study of Adjuvant Whole Pelvic Hypofractionated Radiotherapy for Non-Metastatic Cervical and Endometrial Cancer
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).
Arms & 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.
Outcome measures
Primary
The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment (Phase 1)
The maximum tolerated dose-per-fraction regimen of whole pelvic radiation therapy that will be administered during uterine cancer treatment.
Time frame: 3-5 weeks
Change in patient-reported acute gastrointestinal side effects after completion of hypofractionated radiation (Phase 2)
Change in quality-of-life experience on the bowel and urinary domains
Time frame: 3-5 weeks (end of treament)
Secondary
Change in patient-reported acute urinary side effects
Time frame: 1 month post radiation
Change in gastrointestinal toxicity over time
Time frame: 1 month post radiation
Overall quality of life after treatment
Time frame: 2 years post treatment
Financial Distress of Treatment
Time frame: End of treatment
Treatment Satisfaction
Time frame: End of treatment
Eligibility criteria
Study locations (5)
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
University of Illinois at Chicago (UIC)
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
MD Anderson Cancer Center
Houston, Texas, 77030
Huntsman Cancer Institute
Salt Lake City, Utah, 84112