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FUlvestrant in Gynecological Cancers That Are Potentially Hormone Sensitive: the FUCHSia Study

NCT03926936 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-05-28

No results posted yet for this study

Summary

This phase 2 clinical trial aims to evaluate the efficacy of Fulvestrant, an ER-antagonist, in women with estrogen receptor positive (ER+) low-grade gynecological cancers. The primary objective is to determine the response rate (RR) to Fulvestrant, defined by partial or complete response according to RECIST v1.1 criteria. Secondary objectives include assessing progression-free survival (PFS) over 3 years, clinical benefit (CB), duration of response, safety and tolerability, and quality of life (QoL) in each tumor type group. Exploratory objectives involve evaluating the feasibility of 18F-FES PET imaging for detecting ER expression, the predictive value of sequential 18F-FES PET scans for treatment response, and collecting tumor biopsies and cf-DNA for genetic analysis to identify adaptive response mechanisms to Fulvestrant.

Conditions

  • Endometrial Stromal Sarcoma
  • Adenosarcoma of Uterus
  • Leiomyosarcoma Uterus
  • Endometrial Cancer
  • Sex Cord Stromal Tumor
  • Serous Ovarian Tumor

Interventions

DRUG

Fulvestrant

intramuscular injection (2x 250mg), once every 2 weeks for the first month, and then monthly until completion of the study

Sponsors & Collaborators

  • Kom Op Tegen Kanker

    collaborator OTHER

  • Research Foundation Flanders

    collaborator OTHER

  • Frederic Amant

    lead OTHER

Principal Investigators

  • Frédéric Amant, MD PhD · UZ Leuven

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-13
Primary Completion
2022-04-01
Completion
2022-12-27

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03926936 on ClinicalTrials.gov