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Endometrial Stromal SarcomaPhase 2FUCHSiaNCT03926936

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

A Phase 2 study testing Fulvestrant in people with Endometrial Stromal Sarcoma and Adenosarcoma of Uterus, run by Frederic Amant at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Fulvestrant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
14 sitesin 2 countries
Study dates
13 Mar 2019to 27 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 (low grade endometrial stromal sarcoma, low grade adenosarcoma without sarcomatous overgrowth and low grade leiomyosarcoma), 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, assessed using the Allred scoring system (based on intensity and percentage of positive cells, see Appendix 4), and archival tissue available
  • At least and maximum of 1 prior line of hormonal therapy (tamoxifen, progestins and/or aromatase inhibitors). Response on 1st line hormonal therapy must have lasted for at least 3 months.
Show all 11Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
  • Demonstrate adequate organ function: platelets > 100 x 10E9/L, serum total bilirubin < 1.5x Upper Limit of Normal (ULN) (patients with confirmed Gilbert's syndrome may be included in the study), alanine transaminase or aspartate transaminase < 2.5x ULN if no demonstrable liver metastases or < 5x ULN in presence of liver metastases
  • 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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

Netherlands10 sites

  • Amsterdam University Medical Centers (AMC)

    Amsterdam, North Holland, 1000

  • The Netherlands Cancer Institute (NKI) - Antoni van Leuwenhoek Hospital (NKI-AvL)

    Amsterdam, North Holland, 1000

  • Gynecological Oncology Centrum, Catharina Ziekenhuis

    Eindhoven, North Brabant, 5623 EJ

  • Center for Medical Imaging, University Medical Centrum Groningen

    Groningen, 9713 GZ

  • Obstetrics and Gynaecology, University Medical Centrum Groningen

    Groningen, 9713 GZ

  • Department of Obstetrics and Gynaecology, Leiden University Medical Center

    Leiden, South Holland, 2333 ZA

  • medical Oncology, Maastricht University Medical Centrum+

    Maastricht, Limburg, 6202 AZ

  • Gynaecological Oncology, Radboudumc

    Nijmegen, Gelderland, 6525 GA

  • Gynaecological Oncology, Erasmus MC Cancer Institute

    Rotterdam, South Holland, 3075 EA

  • University Medical Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Belgium4 sites

  • UZ Antwerp

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • CHU de Liege

    Grivegnée, Liège, 4030

  • AZ Sint Maarten

    Mechelen, 2800

Other trials in Belgium

About this study

Official title: An Open-label, Single Arm, Prospective, Multi-center, Tandem Two Stage Designed, Phase II Study to Evaluate the Efficacy of Fulvestrant in Women With Recurrent/Metastatic Estrogen Receptor Positive Gynecological Malignancies

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.

Read the detailed description

In this phase 2 clinical trial, the aim is to evaluate the efficacy of the ER-antagonist Fulvestrant in women with estrogen receptor positive (ER+) low grade gynecological cancers. The primary objective of the study is to determine the response rate (RR) upon Fulvestrant treatment, comprising either partial or complete response, as determined by RECIST v1.1 criteria for each tumor type. The secondary objectives are to: (1) determine progression-free survival (PFS) upon Fulvestrant treatment, after 3 years, in each tumor type group (2) assess clinical benefit (CB) upon Fulvestrant treatment, comprising complete response, partial response and stable disease, as determined by RECIST v1.1 criteria, in each tumor type group (3) assess duration of response in each tumor type group (4) assess safety and tolerability of Fulvestrant administration in each tumor type group (5) assess quality of life (QoL) and symptoms in each tumor type group. As exploratory objectives, the aim is to: (1) evaluate the feasibility of 16α-18F-fluoro-17β-estradiol (18F-FES) PET imaging for detection of ER expression (2) determine the value of sequential 18F-FES PET scans in predicting response to Fulvestrant (3) collect tumor biopsies and cf-DNA from patients enrolled in the trial. These samples will be subsequently characterized at the genetic level, to identify adaptive response mechanisms to Fulvestrant treatment.

Being tested
Fulvestrant
Keywords
fulvestrant, low-grade gynecological cancer, efficacy
Medical subject headings
Sarcoma, Endometrial Stromal, Adenosarcoma of the uterus, Endometrial Neoplasms, Sex Cord-Gonadal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FulvestrantDrug

    Also called Faslodex

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

Study groups in NCT03926936
Study groupRoleWhat they receive
Low-grade uterine sarcomaExperimentalParticipants with low-grade uterine sarcoma
Receives: Drug: Fulvestrant
low-grade endometrial carcinomaExperimentalParticipants with low-grade endometrial carcinoma
Receives: Drug: Fulvestrant
sex cord stromal tumorsExperimentalParticipants with sex cord stromal tumors
Receives: Drug: Fulvestrant
low-grade serous ovarian cancerExperimentalParticipants with low-grade serous ovarian cancer
Receives: Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    partial or complete response, as determined by RECIST v1.1 criteria

    Measured: week 24

Secondary outcomes (6)

  1. progression-free survival

    progression-free survival after 3 years

    Measured: week 156

  2. clinical benefit

    Clinical benefit is defined as the number of patients having complete response, partial response or stable disease, as determined by RECIST v1.1 criteria

    Measured: week 24

  3. duration of response

    duration in weeks and days

    Measured: up to week 156

  4. number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    absolute number of participants

    Measured: up to 56 days after stop study treatment

  5. EQ-5D quality of life assessment

    Quality of life as measured by the EQ-5D questionnaire. EQ-5D has 2 parts-the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The descriptive system comprises 5 health states (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which will be converted into a summary index according to the EQ-5D user guide. The EQ VAS records the self-rated health on an analog scale. For both EQ-5D index and EQ VAS, a higher score indicates a better health status.

    Descriptive statistics of the subscores and the summary score at each visit and the difference with baseline will be reported.

    Measured: Quality of life questionnaires will be completed by the patients at baseline and thereafter 3-monthly up to week 156

  6. EORTC QLQ-C30 quality of life assessment

    Quality of life as measured by the EORTC-QLQ-C30 questionnaire. For EORTC QLQ-C30, functional scores (emotional, role, cognitive, physical, and social) will be pooled and a summary score will be calculated according to Giesinger et al. A higher score indicates better health for functioning and global health status, whereas for the symptom scales a lower score indicates a lower level of symptom burden.

    Descriptive statistics of the subscores and the summary score at each visit and the difference with baseline will be reported.

    Measured: Quality of life questionnaires will be completed by the patients at baseline and thereafter 3-monthly up to week 156

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2019
  2. Study start13 Mar 2019
  3. Primary completion1 Apr 2022
  4. Study completion27 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03926936
Sponsor's protocol ID
S60857
Other IDs
2017-005018-76, 2017
Acronym
FUCHSia
Status last verified
May 2024
First submitted
10 Apr 2019
Last updated
28 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: * Demographics * Medication and Medical history * Physical examination * Height * Weight * Vital signs * ECOG status * Core biopsy * Blood tests (hematological and chemical panels) * Blood sample for cf-DNA analysis * CT and/or MR scan (chest-abdomen/pelvis) * 18F-FDG PET/CT scan * 18F-FES PET/CT or PET/MRI scan * QoL assessment * Fulvestrant administration * Adverse Events

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fulvestrant in people with Endometrial Stromal Sarcoma and Adenosarcoma of Uterus, run by Frederic Amant at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03926936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.

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