RecruitingPhase 3NCT05601700

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

Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer: a Randomized Phase III Trial (LEPRE Trial)


Sponsor

Ente Ospedaliero Ospedali Galliera

Enrollment

132 participants

Start Date

Sep 22, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests letrozole (a hormone-blocking medication usually used for breast cancer) as a maintenance treatment for a rare type of ovarian cancer called low-grade serous carcinoma. After completing standard chemotherapy, participants take letrozole long-term to try to keep the cancer from coming back. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with low-grade serous ovarian, fallopian tube, or peritoneal cancer - Your tumor is confirmed by central pathology review - Your tumor tests positive for estrogen and/or progesterone receptors - You have completed your primary surgery and chemotherapy **You may NOT be eligible if...** - Your cancer is a different type or grade of ovarian cancer - Your tumor is not hormone receptor positive - You have another active cancer - You have serious health conditions that make letrozole unsafe (e.g., severe osteoporosis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLetrozole tablets

ATC: L02BG04

DRUGcarboplatin AUC 5 and paclitaxel 175 mg/m2

ATC: L01XA02 and ATC: L01CD01 respectively


Locations(19)

Ospedale San Donato

Arezzo, AR, Italy

Ospedale degli Infermi

Ponderano, BI, Italy

Ospedale San Martino

Belluno, BL, Italy

Fondazione Poliambulanza

Brescia, BS, Italy

ASST degli Spedali Civili di Brescia

Brescia, BS, Italy

Ospedale Sant'Anna

Como, CO, Italy

IRST

Meldola, FC, Italy

AOU Ferrara

Ferrara, FE, Italy

Medical Oncology Division, Ente Ospedaliero Ospedali Galliera

Genova, Genova, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, MI, Italy

IEO

Milan, MI, Italy

IRCCS Istituto Oncologico Veneto

Padua, PD, Italy

IFO Regina Elena

Roma, RM, Italy

Policlinico Umberto I

Roma, RM, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, Italy

IRCCS Istituto Oncologico Veneto

Castelfranco Veneto, TV, Italy

Ospedale Ca' Foncello

Treviso, TV, Italy

Ospedale Del Ponte

Varese, VA, Italy

AUSL Romagna

Rimini, Italy

View Full Details on ClinicalTrials.gov

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NCT05601700


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