Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer

Study Overview
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Brief Summary
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Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 30 Gy in 5 fractions, once weekly to the pelvis in post operative patients with endometrial cancer.

Official Title
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Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer (ASPIRE)

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Radiation: SABR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with histologically confirmed endometrial adenocarcinoma Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions: High grade histology OR Outer-half myometrial invasion with any risk factors OR FIGO stage II - IIIC1. Age ≥18 years. Patients who are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments. Exclusion Criteria: Patient has had prior pelvic radiotherapy. Patient has Type II endometrial cancer histology (ie. Serous, clear cell or carcinosarcoma). Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease. Patient has a contraindication to CT contrast. Patient has a hip prosthesis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SABR<br>Pelvic SABR for post-op endometrial cancer | Radiation: SABR<br>* SABR to a dose of 30Gy/5 to the pelvis (vaginal and paravaginal tissues as well as regional lymph nodes)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Treatment-Related Adverse Events | The number of participants with acute (<3 months) urinary and bowel treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria | 3 months after accrual is completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Treatment-Related Adverse Events | The number of participants with late (>3 months) urinary and bowel treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria | 5 years after accrual is completed | 
| Disease Local-Regional Failure Rate | The rate of local-regional failure of the disease in participants after adjuvant SABR treatment in the setting of high-risk endometrial cancer. | 5 years after accrual is completed | 
| Quality of Life | The mean decrease in Quality of Life in participants after adjuvant SBRT treatment using EORTC (European Organisation for Research and Treatment of Cancer) core questionnaire (QLQ-C30) with EN-24 companion. | 5 years after accrual is completed |