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NCT04095364 · ClinicalTrials.gov registry record · Phase 3
Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 3 study of Stage III Ovarian Cancer AJCC v8 and Stage III Fallopian Tube Cancer AJCC v8, sponsored by NRG Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT04095364: Active Phase 3 study of Stage III Ovarian Cancer AJCC v8 and Stage III Fallopian Tube Cancer AJCC v8, sponsored by NRG Oncology.
NCT04095364 is a Phase 3 study of Stage III Ovarian Cancer AJCC v8 and Stage III Fallopian Tube Cancer AJCC v8 that is active but no longer recruiting, run by NRG Oncology. The registered enrollment target is 450 participants, above the 79-participant average among 9 other Stage III Ovarian Cancer AJCC v8 trials with a reported enrollment target (470% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04095364, a Phase 3 study of Stage III Ovarian Cancer AJCC v8 and Stage III Fallopian Tube Cancer AJCC v8, is active but no longer recruiting, sponsored by NRG Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.
Primary Outcome
The PFS comparison will be assessed at the second interim and final analyses using a logrank test stratified by country and residual disease status. Estimates for the letrozole/letrozole (L/L) vs paclitaxel/carboplatin/letrozole (CT/L) hazard ratio and its confidence interval will be obtained using a stratified Cox proportional hazards model. Potential confounding factors, including the stratification factors, performance status and self-declared racial designation will be considered in a final
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- DRUG Letrozole
- PROCEDURE Imaging Procedure
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- CTCA at Western Regional Medical Center - Goodyear
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- CARTI Cancer Center - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2019-09-20 |
| Est. Completion | 2028-02-01 |
| Phase | Phase 3 |
What the registry record for NCT04095364 still lists
NCT04095364 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 79-participant average among 9 other Stage III Ovarian Cancer AJCC v8 trials with a reported enrollment target (470% higher).
The record links to 10 conditions, with Stage III Ovarian Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04095364 names 20 study sites across 3 states, led by Alaska, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04095364 about?
NCT04095364 is a clinical study titled "Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in...
What is the current status of trial NCT04095364?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2019-09-20. Estimated completion is 2028-02-01.
What conditions does trial NCT04095364 study?
This clinical trial studies the following conditions: Stage III Ovarian Cancer AJCC v8, Stage III Fallopian Tube Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8, Stage III Primary Peritoneal Cancer AJCC v8, Stage II Ovarian Cancer AJCC v8.
What interventions are being tested in trial NCT04095364?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Letrozole (DRUG), Imaging Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT04095364?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04095364 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04095364's enrollment target sits among peer trials
450 1st of 9 higher than 9 of 9 other Stage III Ovarian Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Ovarian Cancer AJCC v8 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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