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

Study Overview
=================
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

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

Conditions
-----------------
Endometrial Cancer Stage III, Endometrial Cancer Stage IV, Endometrial Cancer Recurrent

Intervention / Treatment
-----------------
* Drug: Hormonal Antineoplastics


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EC patients with HT<br>Patients with advanced stage or recurrent endometrial cancer treated with hormonal therapy | Drug: Hormonal Antineoplastics<br>* Hormonal therapy used for treatment in endometrial cancer patients<br>* Other names: Aromatase inhibitors;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Complete or partial response according to RECIST criteria | 2 years | 
| Progression free survival | Interval from start of hormonal therapy to progressive disease or death | 2 years | 
| Clinical benefit rate | Complete or partial response or stable disease according to RECIST criteria | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hormonal therapy, Endocrine therapy, Translational research, Tumor factors