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

Recruiting

• Conditions: Endometrial Cancer Recurrent; Endometrial Cancer Stage III; Endometrial Cancer Stage IV
• Interventions: Drug: Hormonal Antineoplastics

• Registration Number: NCT03621904
• Lead Sponsor: Radboud University Medical Center

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-09
• Status Verified: 2022-10
• Study Start: 2022-10-15
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18
• Primary Completion: 2026-10-15
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EC patients with HT	Hormonal Antineoplastics	Patients with advanced stage or recurrent endometrial cancer treated with hormonal therapy

Primary Outcome Measures

Name	Time	Method
Response rate	2 years	Complete or partial response according to RECIST criteria
Progression free survival	2 years	Interval from start of hormonal therapy to progressive disease or death
Clinical benefit rate	2 years	Complete or partial response or stable disease according to RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	6 months	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

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Netherlands