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Clinical Trials/NCT03621904
NCT03621904RecruitingNot Applicable

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

Radboud University Medical Center1 site in 1 country150 target enrollmentStarted: October 15, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
150
Locations
1
Primary Endpoint
Response rate

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 110 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

EC patients with HT

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

Intervention: Hormonal Antineoplastics (Drug)

Outcomes

Primary Outcomes

Response rate

Time Frame: 2 years

Complete or partial response according to RECIST criteria

Progression free survival

Time Frame: 2 years

Interval from start of hormonal therapy to progressive disease or death

Clinical benefit rate

Time Frame: 2 years

Complete or partial response or stable disease according to RECIST criteria

Secondary Outcomes

  • Health-related quality of life(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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