PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-110
SponsorRadboud University Medical Center
About this trial
The PROMOTE study aims at optimising use of hormonal therapy in advanced stage and recurrent endometrial cancer analysing tumor tissue taken before start of hormonal therapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Advanced stage (FIGO stage III and IV) and recurrent endometrial cancer
All histologic types of endometrial carcinoma
Planned treatment with any type of hormonal therapy
Biopsy taken within 120 days prior to start of hormonal therapy with no intercurrent therapy between biopsy and start of hormonal therapy.
Disqualifiers
Adjuvant hormonal therapy started following complete resection of endometrial carcinoma
Synchronous use of hormonal therapy for other indications
Endometrial sarcoma or endometrial stroma cell sarcoma
Trial population
Patients with advanced stage and recurrent endometrial cancer treated with hormonal treatment, available biopsy prior to start of hormonal treatment and available follow-up
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hormonal Antineoplastics
DrugHormonal therapy used for treatment in endometrial cancer patients
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: EC patients with HT1 intervention
Trial outcomes
Primary outcomes
1
Response rate
Complete or partial response according to RECIST criteria
Time frame
2 years2
Progression free survival
Interval from start of hormonal therapy to progressive disease or death
Time frame
2 years3
Clinical benefit rate
Complete or partial response or stable disease according to RECIST criteria
Time frame
2 yearsSecondary outcomes
1
Health-related quality of life
Health-related quality of life during hormonal therapy as tested with the validated EORTC-QLQ-C30 and EORTC-QLQ-EN24 quality-of-life scales at start of hormonal therapy and 6 months after start therapy
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Radboud University Medical Center
Lead sponsor
Haukeland University Hospital
Collaborator
Maastricht University Medical Center
Collaborator
Brno University Hospital
Collaborator
Holycross Cancer Center Kielce
Collaborator
Medical University of Lublin
Collaborator
Hospital del Mar
Collaborator
Hospital Vall d'Hebron
Collaborator
Royal Cornwall Hospitals Trust
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator
The Netherlands Cancer Institute
Collaborator
Canisius-Wilhelmina Hospital
Collaborator
Catharina Ziekenhuis Eindhoven
Collaborator
Erasmus Medical Center
Collaborator
Leiden University Medical Center
Collaborator
Source ClinicalTrials.gov