Brief Title
Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer
Official Title
Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer (ASPIRE)
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Acute Treatment-Related Adverse Events
Secondary Outcome
Late Treatment-Related Adverse Events
Condition
Endometrial Cancer
Intervention
SABR
Study Arms / Comparison Groups
SABR
Description: Pelvic SABR for post-op endometrial cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
30
Start Date
January 16, 2020
Completion Date
January 2026
Primary Completion Date
January 2022
Eligibility 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.
Gender
Female
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Saudi Arabia
Location Countries
Saudi Arabia
Administrative Informations
NCT ID
NCT04235179
Organization ID
E-19-4466
Responsible Party
Principal Investigator
Study Sponsor
King Saud University
Study Sponsor
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Verification Date
January 2020