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Efficacy of Letrozole in Recurrent Ovarian Cancer

NCT04421547 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-03-07

No results posted yet for this study

Summary

Randomized phase III multicenter study investigating the role of letrozole in heavily pretreated recurrent ovarian cancer.

Conditions

  • Epithelial Ovarian Cancer

Interventions

DRUG

Letrozole 2.5mg

This study will investigate the role of Letrozole in patients affected by heavily pretreated platinum resistant ovarian cancer, compared to standard treatment.

DRUG

Standard single agent chemotherapy

Either Paclitaxel 80 mg/m2 as a 1-h infusion, on days 1,8,15,22 every 28 days or Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 given every 4 weeks or Topotecan 4mg/m2 IV on days 1,8,15 every 4 weeks or Gemcitabine 1000 mg/m2 IV over 30 min on days 1,8,15 every 28 days.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Claudia Marchetti · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-22
Primary Completion
2024-11-01
Completion
2024-11-04

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04421547 on ClinicalTrials.gov