FUlvestrant in gynecological Cancers that are potentially Hormone Sensitive: the FUCHSia study
- Conditions
- endometrial stromal sarcomauterine adenosarcomaendometrial carcinomasex cord stromal tumorsserous ovarian cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-005018-76-BE
- Lead Sponsor
- niversity Hospitals Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 200
Written informed consent prior admission to the study
Age = 18 years at the moment of signing the informed consent
Recurrent or metastatic low grade uterine sarcomas (LGESS, LGAS without sarcomatous overgrowth and LGLMS), low-grade endometrial carcinomas, sex cord stromal tumors (granulosa cell tumors...) and low grade serous ovarian cancer
Measurable disease, according to RECIST v1.1 criteria, assessed by CT scans
ER-positive tumors based on immunohistochemistry, more than 10% of tumor cells should be positive for ER. After the study, central analysis of ER staining will be assessed using the Allred scoring system (based on intensity and percentage of positive cells, see Appendix 4) and archival tissue (< 3 years old) available
Minimum 1 and maximum 2 prior lines of hormonal therapy (tamoxifen, progestins and/or aromatase inhibitors). Hormone treatments of less than 3 months are not considered as a line of treatment. Thus, patients with 1 or 2 previous lines can be included.
ECOG performance status: 0-2
Demonstrate adequate organ function: creatinine =1.5 X upper limit of normal (ULN), serum total bilirubin = 1.5 X ULN, AST (SGOT) and ALT (SGPT) < 5 X ULN
Post-menopausal status as defined by (i) age 60 or more, or (ii) age 45-59 and satisfying the following criteria: amenorrhea for at least 12 months and FSH in postmenopausal range, or (iii) = 18 years of age and having had a bilateral oophorectomy
Be willing to receive 18F-FES PET scan. Exceptions will be made in case of (i) patients living far from one of the imaging centers and for whom travelling would be a too high burden for their physical conditions; (ii) patients who received tamoxifen within 8 weeks prior to study Day 1. These patients will be enrolled, but they will not receive a FES PET scan
Be willing to donate a core tumor biopsy if technically feasible
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
•Any other active malignancy or primary malignancy diagnosed within the previous 5 years, except for adequately treated squamous or basal cell carcinoma of the skin or in situ cervical carcinoma
•Patients currently receiving (and unwilling to discontinue) any estrogen replacement therapy.
•Patients participating in a study or having participated in a study of an investigational agent and received study therapy (or used an investigational device) within 4 weeks prior to study Day 1
•Patients who received prior chemo- or targeted therapy within 4 weeks prior to study Day 1 or who has not recovered from adverse events (i.e., adverse event not resolved to = Grade 1 or baseline), due to a previously administered agent
•Patients with no archival tissue available, except for patients from whom an additional fresh core biopsy can be obtained for ER assessment
•Any other disease, metabolic dysfunction, physical examination or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interfere with obtaining informed consent.
•Any condition not permitting compliance with the study protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the response rate (RR) upon Fulvestrant treatment, comprising either partial or complete response, as determined by RECIST v1.1 criteria, in each tumor type group;Secondary Objective: •To determine progression-free survival (PFS) upon Fulvestrant treatment, after 3 years, in each tumor type group <br>•To assess duration of response in each tumor type group<br>•To assess safety and tolerability of Fulvestrant administration in each tumor type group<br>•To assess quality of life (QoL) and symptoms in each tumor type group<br>;Primary end point(s): Response rate (RR) upon Fulvestrant treatment in each tumor type group for the total number of patients from both the exploratory and confirmation cohort (interim analysis planned at Week 24), as determined by RECIST v1.1 criteria and assessed by computer tomography (CT) scans ;Timepoint(s) of evaluation of this end point: Every 3 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Progression-free survival (PFS) at 3 years in each tumor type group<br>•Overall survival (OS)<br>•Time to progression (TTP)<br>•Clinical benefit rate (CBR) (CR + PR + stable disease [SD], SD of any duration) at interim analysis (IA, Week 24) and after 3 years, for each tumor type group<br>•Safety and tolerability of Fulvestrant administration in each tumor type group<br>•Change from baseline in QoL scores, as assessed by questionnaires EQ-5D and EORTC QLQ-C30 at the time of inclusion, at the end of the treatment and during follow-up<br>;Timepoint(s) of evaluation of this end point: PFS: at 3 years<br>OS: at time of death<br>Time to progression: at time of diagnosis of progressive disease<br>Clinical benefit rate: every 3 months<br>Safety and tolerability: every 3 months<br>QoL: every 3 months