Optimizing hormonal therapy for advanced and recurrent endometrial cancer
PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer
This study is trying to find better ways to use hormonal therapy for women with advanced or recurring endometrial cancer by looking at their tumor samples to see who might benefit most from this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | Female |
| Sponsor | Radboud University Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT03621904 on ClinicalTrials.gov |
What this trial studies
The PROMOTE study focuses on improving the use of hormonal therapy in patients with advanced and recurrent endometrial cancer by analyzing tumor tissue collected before treatment. It addresses the lack of consensus and quality data regarding patient selection and predictive biomarkers for hormonal treatment. This observational study aims to refine clinical criteria for selecting patients who may benefit from hormonal therapy, which is generally better tolerated than chemotherapy. Given the increasing incidence of endometrial cancer, especially among elderly women, this study seeks to provide more effective and less aggressive treatment options.
Who should consider this trial
Good fit: Ideal candidates include women with advanced stage (FIGO stage III and IV) or recurrent endometrial cancer who are planned to receive hormonal therapy.
Not a fit: Patients who have undergone adjuvant hormonal therapy after complete resection or those with endometrial sarcoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective hormonal treatment options for patients with advanced endometrial cancer.
How similar studies have performed: While there is limited consensus on hormonal therapy for this condition, similar studies have shown promise in optimizing treatment approaches based on tumor characteristics.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nijmegen
- Radboudumc — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Hanny Pijnenborg, MD PhD — Radboud University Medical Center
- Study coordinator: Maartje Luijten, MD
- Email: Maartje.luijten@radboudumc.nl
- Phone: +31243616683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.