Endometrial Cancer
Conditions
Brief 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).
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.
Sponsors
University of Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary cervical cancer or uterine cancer of any histology * Age ≥ 18 years. * Non-metastatic disease according to the International Federation of Gynecology and Obstetrics (FIGO). * Must have been treated with definitive intent, including standard-of-care hysterectomy, without any gross residual disease post-operatively. Nodal dissection is not required, but if it is not performed, then diagnostic imaging to confirm absence of gross pelvic or para-aortic disease should be obtained pre- or post-operatively. * Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. Chemotherapy before or after radiotherapy is acceptable. * Eastern Cooperative Oncology Group (ECOG) PS≤ 2 * Able to provide informed consent and willingness to sign an approved consent form
Exclusion criteria
* Distant metastases as determined clinically or radiographically based upon standard-of-care work-up for endometrial cancer. * Concurrent (or other) chemotherapy occurring at the time of study. * Gross residual disease (cancer cells that remain after attempts to remove the cancer have been made) post-operatively and/or at the time of radiation based upon pre-op or post-op imaging, intra-operative findings, and gynecologic oncologists' judgment. * History of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical management, or prior radiation therapy directed to the pelvis. * Unresolved grade 2 or higher chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation. * Recommendation to undergo para-aortic nodal irradiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment (Phase 1) | 3-5 weeks | The maximum tolerated dose-per-fraction regimen of whole pelvic radiation therapy that will be administered during uterine cancer treatment. |
| Change in patient-reported acute gastrointestinal side effects after completion of hypofractionated radiation (Phase 2) | 3-5 weeks (end of treament) | Change in quality-of-life experience on the bowel and urinary domains |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient-reported acute urinary side effects | 1 month post radiation | Determined using frequency of reported events of urinary frequency, urinary incontinence, and urinary urgency on the Patient Reported Outcomes (PRO-CTCAE) |
| Change in gastrointestinal toxicity over time | 1 month post radiation | Determined using frequency of reported events of diarrhea and proctitis on the Patient Reported Outcomes (PRO-CTCAE) |
| Overall quality of life after treatment | 2 years post treatment | Total quality of life score from the Functional Assessment of Cancer Therapy (FACT)-General questionnaire will be calculated. A higher score indicates better quality of life. |
| Financial Distress of Treatment | End of treatment | Change in reported financial distress in patients as reported on the Functional Assessment of Chronic Illness Therapy- COST (FACIT-COST) questionnaire. Higher scores on scale of 0-5 indicates better financial wellbeing. |
| Treatment Satisfaction | End of treatment | We will characterize the measure of regret experienced in the study patients over time as reported on the Decision Regret Scale questionnaire. Higher scores on scale of 0-100 indicates high regret. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristina Son, MD
University of Chicago
Outcome results
None listed