Actively Recruiting

Age: 18Years - 110Years
FEMALE
ID03621904

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

Led by Radboud University Medical Center · Updated on 2023-01-18

150

Participants Needed

1

Research Sites

45 weeks

Total Duration

On this page

Sponsors

R

Radboud University Medical Center

Lead Sponsor

H

Haukeland University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The PROMOTE study focuses on women with advanced stage (FIGO stage III and IV) or recurrent endometrial cancer. Researchers aim to improve how hormonal therapy is used by analyzing tumor tissue taken before treatment to better predict which patients may respond. This is important because hormonal therapy is less aggressive and better tolerated than chemotherapy, but current use relies heavily on physician experience rather than detailed molecular criteria. Participants are women planned to receive hormonal therapy for their advanced or recurrent endometrial cancer. The study observes these patients as they undergo hormonal treatment without altering their care. Tumor biopsies taken within 120 days before starting therapy are analyzed to correlate molecular features with treatment response. The study does not involve additional experimental treatments but collects clinical and molecular data during usual care. During the study, participants' responses to hormonal therapy are tracked over two years, measuring response rate, progression-free survival, and clinical benefit. Quality of life is also assessed over six months. Researchers collect information from biopsies and monitor health outcomes without adding extra interventions. The study runs from October 2022 until September 2027, allowing long-term follow-up of participants' treatment outcomes and quality of life.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 110Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with advanced stage (FIGO stage III and IV) or recurrent endometrial cancer
  • Any histologic type of endometrial carcinoma
  • Planned treatment with any type of hormonal therapy
  • Biopsy taken within 120 days prior to starting hormonal therapy with no treatment in between
Not Eligible

You will not qualify if you...

  • Use of adjuvant hormonal therapy after complete removal of endometrial carcinoma
  • Concurrent hormonal therapy for other medical reasons
  • Diagnosis of endometrial sarcoma or endometrial stroma cell sarcoma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 2 years

Participants receive hormonal therapy for advanced or recurrent endometrial cancer.

Regular visits during treatment period

Follow-up

Duration - Up to 2 years

Participants are monitored to evaluate treatment response and quality of life after hormonal therapy.

Visits up to 2 years after starting treatment, including assessments at 6 months and 2 years

Trial Site Locations

Total: 1 location

1

Radboudumc

Nijmegen, Netherlands, 6525GA

Actively Recruiting

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Research Team

M

Maartje Luijten, MD

H

Hanny Pijnenborg, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study.

Gini F Fleming, Virginia L Brunetto, David Cella...

https://pubmed.ncbi.nlm.nih.gov/15169803

Selection of personalized patient therapy through the use of knowledge-based computational models that identify tumor-driving signal transduction pathways.

Wim Verhaegh, Henk van Ooijen, Márcia A Inda...

https://pubmed.ncbi.nlm.nih.gov/24695361