Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous

Status Recruiting

Clinical Trial Summary

This is an Italian, multicenter, randomized, open-label phase III trial which will evaluate if Letrozole is superior to standard adjuvant chemotherapy in patients with hormone receptor positive low-grade serous epithelial carcinoma of the ovary (LGSCO). The hypothesis is that letrozole will significantly prolong median progression free survival (PFS) compared with the standard chemotherapy treatment, namely carboplatin AUC 5 and paclitaxel 175 mg/m2.

Clinical Trial Description

Primary objective: To determine if letrozole is superior to standard chemotherapy in terms of progression-free survival (PFS) in the first line treatment of patients with advanced low-grade serous epithelial ovarian carcinoma positive for estrogen and/or progesterone receptors. Secondary objectives: - to evaluate the response of tumor to letrozole compared with standard chemotherapy in terms of objective response rate (ORR); - to test the predictive effect of ER and PgR on response to letrozole in terms of PFS and ORR; - to evaluate the possible negative association between the effect of letrozole, in terms of PFS and ORR, and the proliferative index Ki67; - to evaluate the impact of letrozole compared with the impact of standard chemotherapy on patients' health related quality of life evaluated by Menopausal Quality of Life Questionnaire (MENQOL); - to evaluate the impact of letrozole compared with standard chemotherapy on patients' musculoskeletal pain evaluated by Brief Pain Inventory - Short Form (BPISF); - to evaluate the effect on overall survival (OS). As most patients will recur and will be switched to chemotherapy and vice versa, OS is not expected to be significantly different; - to evaluate the safety of letrozole compared with standard chemotherapy according to CTCAE v 5.0. Translational objectives: - to characterize the mutational profile and gene expression of the disease by NGS (next-generation sequencing) methodology on tissue samples; - to evaluate the circulating tumor DNA (ctDNA) on liquid biopsies as a tool to monitor the disease response. ;

Study Design

Related Conditions & MeSH terms

Carcinoma, Ovarian Epithelial

Clinical Trial Details

NCT number	NCT05601700
Study type	Interventional
Source	Ente Ospedaliero Ospedali Galliera
Contact	Andrea DeCensi, Prof.
Phone	+39(0)105634501
Email	andrea.decensi@galliera.it
Status	Recruiting
Phase	Phase 3
Start date	September 22, 2022
Completion date	September 22, 2029

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial) — LEPRE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms