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Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Patients with advanced stage or recurrent endometrial cancer treated with hormonal therapy

Hormonal therapy used for treatment in endometrial cancer patients

Hormonal Antineoplastics

Maartje Luijten, MD

Hanny Pijnenborg, MD PhD

Maartje Luijten

Hanny Pijnenborg

Roy Lalisang, MD PhD prof

Andrea Romano, MD PhD

Willem Jan Van Weelden, MD

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

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

Tumor samples originating from before start of hormonal therapy

PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer

Complete or partial response according to RECIST criteria

Interval from start of hormonal therapy to progressive disease or death

Complete or partial response or stable disease according to RECIST criteria

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer	NCT03621904	Endometrial Can... Endometrial Can... Endometrial Can...	Hormonal Antine...	18 Years - 110 Years	Radboud University Medical Center
PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer	NCT03621904	Endometrial Can... Endometrial Can... Endometrial Can...	Hormonal Antine...	18 Years - 110 Years	Radboud University Medical Center
PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer	NCT03621904	Endometrial Can... Endometrial Can... Endometrial Can...	Hormonal Antine...	18 Years - 110 Years	Radboud University Medical Center

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