Status:
COMPLETED
Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus.
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Endometrioid Adenocarcinoma
Serous Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Advanced technology has enabled radiation oncologists to more accurately and precisely target radiation to areas at risk while maximally sparing healthy tissue. Furthermore, there is growing evidence ...
Eligibility Criteria
Inclusion
- Patients, who have undergone hysterectomy for curative intent, with histologically confirmed endometrioid adenocarcinoma, serous or clear cell carcinoma, or carcinosarcoma or dedifferentiated carcinoma
- Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions:
- High grade histology OR
- Outer-half myometrial invasion and FIGO grade 1-2 OR
- FIGO stage II - IIIC1 (all gross nodal disease must be resected)
- Patient is willing and able to give informed consent to participate in this clinical trial.
- 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. Adjuvant systemic therapy may be given before or after radiation treatment.
- Patient must be willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol.
- Primary language of the patient must be English or, if a patient's primary language is not English, they are still able to participate provided the QLQ-C30 and EN-24 is available in their primary language.
Exclusion
- Patient has had prior pelvic radiotherapy.
- Patient has received neo-adjuvant systemic therapy
- 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 iodinated CT contrast.
- Patient has a hip prosthesis.
Key Trial Info
Start Date :
August 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04458597
Start Date
August 26 2020
End Date
May 14 2024
Last Update
August 1 2025
Active Locations (1)
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1
London Regional Cancer Program
London, Ontario, Canada, N6A 5W9