Stereotactic pelvic radiation for endometrial cancer patients
Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer (ASPIRE)
This study tests if a targeted radiation treatment can help improve outcomes for patients with endometrial cancer after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | King Saud University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Riyadh) |
| Trial ID | NCT04235179 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Stereotactic Ablative Radiation (SABR) in patients with post-operative endometrial cancer. Participants will receive a total dose of 30 Gy delivered in 5 fractions once weekly to the pelvis. The study aims to evaluate the effectiveness of this targeted radiation therapy in improving outcomes for patients who meet specific eligibility criteria related to their cancer stage and histology. The trial focuses on patients who are candidates for adjuvant pelvic radiation therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed endometrial adenocarcinoma who meet specific criteria for adjuvant pelvic radiation.
Not a fit: Patients with prior pelvic radiotherapy, Type II endometrial cancer histology, or contraindications to pelvic radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes and reduce recurrence rates in patients with endometrial cancer.
How similar studies have performed: While there is ongoing research in the field of stereotactic radiation for various cancers, this specific approach in endometrial cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Riyadh
- King Saud University Medical City — Riyadh, Saudi Arabia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.