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

January 17, 2023 updated by: Radboud University Medical Center
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hanny Pijnenborg, MD PhD
  • Phone Number: +31243616683

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EC patients with HT
Patients with advanced stage or recurrent endometrial cancer treated with hormonal therapy
Drug: Hormonal Antineoplastics
Hormonal therapy used for treatment in endometrial cancer patients
Other Names:
  • Progesterone
  • Tamoxifen
  • Aromatase inhibitors

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Maastricht University Medical Center
Erasmus Medical Center
Catharina Ziekenhuis Eindhoven
Haukeland University Hospital
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
The Netherlands Cancer Institute
Leiden University Medical Center
Hospital del Mar
Brno University Hospital
Medical University of Lublin
Hospital Vall d'Hebron
Canisius-Wilhelmina Hospital
Royal Cornwall Hospitals Trust
Holycross Cancer Center Kielce

Investigators

  • Principal Investigator: Hanny Pijnenborg, MD PhD, Radboud University Medical Center
  • Principal Investigator: Andrea Romano, MD PhD, Maastricht University
  • Principal Investigator: Roy Lalisang, MD PhD prof, Maastricht University Medical Center
  • Principal Investigator: Willem Jan Van Weelden, MD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2022

Primary Completion (Anticipated)

October 15, 2026

Study Completion (Anticipated)

September 1, 2027

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-3803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

This is not yet established

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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