Status:
TERMINATED
Study of Megestrol Acetate in Grade 2 Endometrioid Endometrial Cancer
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Ontario Institute for Cancer Research
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This is a single centre, single arm, open label, preoperative window of opportunity study. Grade 2 endometrioid endometrial carcinoma patients awaiting surgery will be prospectively recruited to recei...
Detailed Description
The incidence of endometrial cancer is increasing due to the rising rates of obesity. Further, the average age at onset is decreasing. As a result, there is a growing interest in fertility-sparing tre...
Eligibility Criteria
Inclusion
- Adult female patient 18 years of age or older.
- Confirmed diagnosis of FIGO grade 2 endometrioid endometrial cancer on preoperative endometrial biopsy read by a pathologist with a subspecialty in gynecologic pathology.
- Stage 1 endometrioid endometrial cancer on preoperative endometrial biopsy.
- P53 wild type immunohistochemistry on preoperative endometrial biopsy.
- Patients eligible for primary staging surgery for definitive treatment for their cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Required Initial Laboratory Values obtained within 3 days of enrolment following standard of care protocols: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3; Platelet Count ≥ 100,000/mm3; eGFR ≥ 60 mL/min/1.73m2; Total Bilirubin ≤ 1.5 x upper limit of normal (ULN); AST / ALT ≤ 2.5 x upper limit of normal (ULN).
- Informed consent for this study is obtained and signed by the participant or have an acceptable Substitute Decision Maker (SDM) capable of signing the informed consent form on behalf of the participant.
Exclusion
- Patients cannot be receiving systemic or hormonal therapy for treatment of the endometrial cancer.
- Prior radiation therapy for treatment of the endometrial cancer is not allowed.
- Stage 2 or 3 endometrioid endometrial cancer on preoperative endometrial biopsy.
- Abnormal p53 immunohistochemistry on preoperative endometrial biopsy.
- History of an allergic reaction to medroxyprogesterone acetate.
- History of venous thromboembolic event (including previous deep vein thrombosis or pulmonary embolism).
- Family history of venous thromboembolic event.
- Have a \>20 pack-year smoking history.
- Patients unwilling or unable to follow the study protocol schedule.
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05332483
Start Date
July 5 2022
End Date
October 12 2023
Last Update
November 3 2023
Active Locations (1)
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1
Sunnybrook Health Sciences
Toronto, Ontario, Canada, M4N 3M5