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NCT02397083 · ClinicalTrials.gov registry record · Phase 2
Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer
A Phase 2 study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
- 18
- Study locations
NCT02397083: Active Phase 2 study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.
NCT02397083 is a Phase 2 study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 102 participants, below the 192-participant average among 5 other FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma trials with a reported enrollment target (47% lower). The trial reports 18 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02397083, a Phase 2 study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
- 18
- Study locations
Study Summary
This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer. The levonorgestrel-releasing intrauterine system is designed to prevent pregnancy by releasing a hormone called levonorgestrel, which is a type of progesterone. Progesterone is a common type of hormone that is used to prevent pregnancy and may prevent or slow tumor cell growth. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether the levonorgestrel-releasing intrauterine system works better with or without everolimus in treating patients with atypical hyperplasia or stage IA grade 1 endometrial cancer.
Primary Outcome
Estimated with a 2-sided 90% confidence interval.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Everolimus
- DEVICE Levonorgestrel-Releasing Intrauterine System
Study Locations (18)
Texas
- MD Anderson in The Woodlands - Conroe
- Memorial Hermann Memorial City Medical Center - Houston
- Lyndon Baines Johnson General Hospital - Houston
- M D Anderson Cancer Center - Houston
- The Woman's Hospital of Texas - Houston
- MD Anderson West Houston - Houston
- MD Anderson League City - League City
- MD Anderson in Sugar Land - Sugar Land
Colorado
- North Colorado Medical Center - Greeley
- McKee Medical Center - Loveland
New Jersey
- Cooper Hospital University Medical Center - Camden
- MD Anderson Cancer Center at Cooper-Voorhees - Voorhees Township
Hawaii
- Queen's Medical Center - Honolulu
Michigan
- Covenant HealthCare Mackinaw - Saginaw
New York
- Northwell Health - New Hyde Park
Ohio
- OhioHealth Mansfield Hospital - Mansfield
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2015-09-23 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 2 |
What the registry record for NCT02397083 still lists
NCT02397083 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 5 other FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma trials with a reported enrollment target (47% lower).
The record links to 3 conditions, with FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02397083 lists 18 locations in 9 states (Texas, Colorado, New Jersey).
Frequently Asked Questions
What is clinical trial NCT02397083 about?
NCT02397083 is a clinical study titled "Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer". This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer. The levonorgestrel-releas...
What is the current status of trial NCT02397083?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2015-09-23. Estimated completion is 2026-09-30.
What conditions does trial NCT02397083 study?
This clinical trial studies the following conditions: FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, Atypical Endometrial Hyperplasia.
What interventions are being tested in trial NCT02397083?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Everolimus (DRUG), Levonorgestrel-Releasing Intrauterine System (DEVICE).
Who is sponsoring clinical trial NCT02397083?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02397083 being conducted?
This trial has 18 study locations across Colorado, Hawaii, Michigan, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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