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NCT03671811 · ClinicalTrials.gov registry record · Phase 2
Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy
A Phase 2 study of Endometrial Carcinoma and Atypical Endometrial Hyperplasia, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT03671811: Active Phase 2 study of Endometrial Carcinoma and Atypical Endometrial Hyperplasia, sponsored by City of Hope Medical Center.
NCT03671811 is a Phase 2 study of Endometrial Carcinoma and Atypical Endometrial Hyperplasia that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 44 participants, below the 389-participant average among 27 other Endometrial Carcinoma trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03671811, a Phase 2 study of Endometrial Carcinoma and Atypical Endometrial Hyperplasia, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well megestrol acetate with or without pterostilbene works in treating patients with endometrial cancer undergoing hysterectomy. Drugs used in chemotherapy, such as megestrol acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pterostilbene is an antioxidant found in blueberries or grapes, and it has been shown to be effective in killing tumor cells and reducing cancer burden. It is not yet known whether giving megestrol acetate with or without pterostilbene may work better in treating patients with endometrial cancer.
Primary Outcome
Ki-67 represents a specific nuclear marker for cell proliferation that is measured by staining with specific antibodies by immunohistochemical (IHC) staining. The Ki-67 proliferation index is defined as percent tumor cells staining positive, and measured on a continuous scale of 0-100%, with higher values indicating higher proliferation. Ki-67 hotspot values were assessed at two time-points during this study, prior to treatment with megace +/- pterostilbene (pre-treatment), and following complet
Conditions Studied
Interventions
- DRUG Megestrol Acetate
- BIOLOGICAL Pterostilbene
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2019-01-21 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 2 |
What the registry record for NCT03671811 still lists
NCT03671811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 389-participant average among 27 other Endometrial Carcinoma trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Endometrial Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Megestrol Acetate is the first listed.
NCT03671811 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03671811 about?
NCT03671811 is a clinical study titled "Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy". This phase II trial studies how well megestrol acetate with or without pterostilbene works in treating patients with endometrial cancer undergoing hysterectomy. Drugs used in chemotherapy, such as megestrol acetate, work in different ways to stop the growth of tumor cells, either by killing the cell...
What is the current status of trial NCT03671811?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2019-01-21. Estimated completion is 2026-03-30.
What conditions does trial NCT03671811 study?
This clinical trial studies the following conditions: Endometrial Carcinoma, Atypical Endometrial Hyperplasia.
What interventions are being tested in trial NCT03671811?
The interventions under investigation include: Megestrol Acetate (DRUG), Pterostilbene (BIOLOGICAL).
Who is sponsoring clinical trial NCT03671811?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03671811 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03671811's enrollment target sits among peer trials
44 21st of 27 higher than 7 of 27 other Endometrial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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