Clinical trial NCT03621904: PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer
Official title: PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer Stage III
Endometrial Cancer Stage IV
Endometrial Cancer Recurrent
Keywords: Hormonal therapy
Endocrine therapy
Translational research
Tumor factors
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Maastricht University Medical Center
name: Brno University Hospital
name: Holycross Cancer Center Kielce
name: Medical University of Lublin
name: Hospital del Mar
name: Hospital Vall d'Hebron
name: Royal Cornwall Hospitals Trust
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: The Netherlands Cancer Institute
name: Canisius-Wilhelmina Hospital
name: Catharina Ziekenhuis Eindhoven
name: Erasmus Medical Center
name: Leiden University Medical Center
First posted: 2018-08-09
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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

Brief summary: 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

Detailed description: There is limited consensus about the position of hormonal treatment in advanced and metastatic endometrial carcinoma (EC). This is due to lack of good quality data on patient selection, and predictive biomarkers. Consequently, consideration of hormonal therapy is subjected to personal experience of the treating physician, rather than on refined clinical and up-to-date molecular criteria. Hormonal therapy has limited side-effects, and is better tolerated than systematic chemotherapy. Since EC patients are often elderly women with comorbidities, more effective and less aggressive treatment options are needed, underlining the urgency of an explorative study on this topic.

Endometrial cancer is the most common malignancy of the female genital tract in developed countries, with increasing incidence due to obesity and increased life expectancy. Most patients are diagnosed at an early stage, and have a favourable prognosis with surgery alone. Yet, 20% of the patients present with advanced or metastatic EC and have a poor outcome even with systemic treatment. Response rate of chemotherapy in advanced or metastatic EC is 30-60%, dependent of previous chemotherapy, with a progression free survival (PFS) of 3-14 months and 40% treatment related morbidity. In comparison, response to hormonal therapy is 20%-40%, with side effects in less than 5%. The overall PFS is 3 months, yet for those who respond the PFS can be up to several years.

To improve selective use of hormonal therapy in EC by evaluating applied hormonal therapy in advanced and metastatic EC and correlate response to molecular tumour analysis and translate this knowledge after validation into clinical practice

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Response rate
timeFrame: 2 years
measure: Progression free survival
timeFrame: 2 years
measure: Clinical benefit rate
timeFrame: 2 years
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: Hanny Pijnenborg, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Roy Lalisang, MD PhD prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Andrea Romano, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Willem Jan Van Weelden, MD
role: PRINCIPAL_INVESTIGATOR
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