Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Biopsy Procedure: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Carboplatin: Given IV
Imaging Procedure: Undergo medical imaging
Letrozole: Given PO
Paclitaxel: Given IV
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.
Eligibility
Primary outcome measure(s)
- Progression-free survival (PFS) — Time from the randomized treatment assignment to documentation of disease progression (Response Evaluation Criteria in Solid Tumors 1.1) or death from any cause, whichever comes first, assessed up to 8 years
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 exploratory model. A forest plot of treatment hazard ratios with confidence intervals within subgroups will also be reported. PFS will be characterized by treatment group with Kaplan-Meier plots and estimates of the median PFS.
Trial sites (909)
| Facility | City | Region | Status |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | Anchorage | Alaska | |
| Anchorage Radiation Therapy Center | Anchorage | Alaska | |
| Alaska Breast Care and Surgery LLC | Anchorage | Alaska | |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | |
| Alaska Women's Cancer Care | Anchorage | Alaska | |
| Anchorage Oncology Centre | Anchorage | Alaska | |
| Katmai Oncology Group | Anchorage | Alaska | |
| Providence Alaska Medical Center | Anchorage | Alaska | |
| Fairbanks Memorial Hospital | Fairbanks | Alaska | |
| CTCA at Western Regional Medical Center | Goodyear | Arizona | |
| Kingman Regional Medical Center | Kingman | Arizona | |
| Cancer Center at Saint Joseph's | Phoenix | Arizona | |
| University of Arizona Cancer Center-Orange Grove Campus | Tucson | Arizona | |
| Banner University Medical Center - Tucson | Tucson | Arizona | |
| University of Arizona Cancer Center-North Campus | Tucson | Arizona | |
| Mercy Hospital Fort Smith | Fort Smith | Arkansas | |
| CHI Saint Vincent Cancer Center Hot Springs | Hot Springs | Arkansas | |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | Jonesboro | Arkansas | |
| CARTI Cancer Center | Little Rock | Arkansas | |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | |
| Kaiser Permanente-Deer Valley Medical Center | Antioch | California | |
| Mission Hope Medical Oncology - Arroyo Grande | Arroyo Grande | California | |
| PCR Oncology | Arroyo Grande | California | |
| Sutter Auburn Faith Hospital | Auburn | California | |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | |
| Kaiser Permanente-Bellflower | Bellflower | California | |
| Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | |
| Keck Medicine of USC Buena Park | Buena Park | California | |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | |
| Mills-Peninsula Medical Center | Burlingame | California | |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California | |
| Mercy Cancer Center - Carmichael | Carmichael | California | |
| Mercy San Juan Medical Center | Carmichael | California | |
| Eden Hospital Medical Center | Castro Valley | California | |
| Community Cancer Institute | Clovis | California | |
| University Oncology Associates | Clovis | California | |
| Sutter Davis Hospital | Davis | California | |
| City of Hope Comprehensive Cancer Center | Duarte | California | |
| Kaiser Permanente Dublin | Dublin | California | |
| Mercy Cancer Center - Elk Grove | Elk Grove | California |
+ 869 more sites — see the full list on the official registry below.
More NRG Oncology trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04095364 on ClinicalTrials.gov ↗ ← All trials in South Korea