Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer

Phase 1

Recruiting

• Conditions: Endometrial Cancer
• Interventions: Radiation: Hypofractionated Radiation; Other: Clinical Follow-Up and Assessments

• Registration Number: NCT04683653
• Lead Sponsor: University of Chicago

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-24
• Study Start: 2021-01-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-05-22
• Study Completion: 2025-05-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Hypofractionated Radiation Treatment (Dose-Finding Arm)	Hypofractionated Radiation	All study participants in this arm will receive hypofractionated whole pelvic radiation treatment for a shortened time period of 3-5 weeks. The goal of this arm is to establish a safe and tolerable dose of shortened (hypofractionated) pelvic radiation treatment for study participants. Once a safe and tolerable dose is established for this shortened form of radiation treatment, participants who meet criteria for the second phase of this study will participate in an expansion cohort that will explore the efficacy (how effective shortened/hypofractionated radiation treatment is for treating endometrial cancer).
Expansion Cohort (Efficacy Arm)	Clinical Follow-Up and Assessments	Participants in this arm will test how effective hypofractionated/shortened whole radiation treatment is ("efficacy") at the dose established in the first phase of this study by following up with their doctors to report their current health status and symptoms during clinical visits. Participants will return for routine clinical follow-up approximately 1 month following radiation, then at 3 months following radiation, then every 3 months for the next 2 years following treatment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

University of Illinois at Chicago (UIC); 🇺🇸 Chicago, Illinois, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States