Endometrial Cancer
Conditions
Brief summary
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.
Interventions
RADIATIONSABR
SABR to a dose of 30Gy/5 to the pelvis (vaginal and paravaginal tissues as well as regional lymph nodes)
Sponsors
King Saud University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Treatment-Related Adverse Events | 3 months after accrual is completed | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Treatment-Related Adverse Events | 5 years after accrual is completed | 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 |
| Disease Local-Regional Failure Rate | 5 years after accrual is completed | The rate of local-regional failure of the disease in participants after adjuvant SABR treatment in the setting of high-risk endometrial cancer. |
| Quality of Life | 5 years after accrual is completed | 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. |
Countries
Saudi Arabia
Outcome results
None listed