Back to resultsAdjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer (ASPIRE)
Primary Purpose
Endometrial Cancer
Status
Recruiting
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
SABR
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer
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.
Sites / Locations
- King Saud University Medical CityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SABR
Arm Description
Pelvic SABR for post-op endometrial cancer
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
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.
Full Information
NCT ID
NCT04235179
First Posted
January 16, 2020
Last Updated
January 19, 2020
Sponsor
King Saud University
1. Study Identification
Unique Protocol Identification Number
NCT04235179
Brief Title
Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer
Acronym
ASPIRE
Official Title
Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer (ASPIRE)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SABR
Arm Type
Experimental
Arm Description
Pelvic SABR for post-op endometrial cancer
Intervention Type
Radiation
Intervention Name(s)
SABR
Intervention Description
SABR to a dose of 30Gy/5 to the pelvis (vaginal and paravaginal tissues as well as regional lymph nodes)
Primary Outcome Measure Information:
Title
Acute Treatment-Related Adverse Events
Description
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
Time Frame
3 months after accrual is completed
Secondary Outcome Measure Information:
Title
Late Treatment-Related Adverse Events
Description
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
Time Frame
5 years after accrual is completed
Title
Disease Local-Regional Failure Rate
Description
The rate of local-regional failure of the disease in participants after adjuvant SABR treatment in the setting of high-risk endometrial cancer.
Time Frame
5 years after accrual is completed
Title
Quality of Life
Description
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.
Time Frame
5 years after accrual is completed
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
King Saud University Medical City
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasir Alayed, MD
Phone
+966114671546
Email
yalayed@ksu.edu.sa
First Name & Middle Initial & Last Name & Degree
Yasir Alayed, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer
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