PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer (PROMOTE)
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| ClinicalTrials.gov Identifier: NCT03621904 |
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Recruitment Status :
Recruiting
First Posted : August 9, 2018
Last Update Posted : January 18, 2023
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| Condition or disease | Intervention/treatment |
|---|---|
| Endometrial Cancer Stage III Endometrial Cancer Stage IV Endometrial Cancer Recurrent | Drug: Hormonal Antineoplastics |
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 [Patient Registry] |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 2 Years |
| Official Title: | PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer |
| Actual Study Start Date : | October 15, 2022 |
| Estimated Primary Completion Date : | October 15, 2026 |
| Estimated Study Completion Date : | September 1, 2027 |
| Group/Cohort | Intervention/treatment |
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EC patients with HT
Patients with advanced stage or recurrent endometrial cancer treated with hormonal therapy
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Drug: Hormonal Antineoplastics
Hormonal therapy used for treatment in endometrial cancer patients
Other Names:
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- 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
- 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
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years to 110 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Endometrial cancer patients |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621904
| Contact: Maartje Luijten, MD | +31243616683 | Maartje.luijten@radboudumc.nl | |
| Contact: Hanny Pijnenborg, MD PhD | +31243616683 |
| Netherlands | |
| Radboudumc | Recruiting |
| Nijmegen, Netherlands, 6525GA | |
| Contact: Maartje Luijten Maartje.luijten@radboudumc.nl | |
| Contact: Hanny Pijnenborg Hanny.ma.pijnenborg@radboudumc.nl | |
| Principal Investigator: | Hanny Pijnenborg, MD PhD | Radboud University Medical Center | |
| Principal Investigator: | Roy Lalisang, MD PhD prof | Maastricht University Medical Center | |
| Principal Investigator: | Andrea Romano, MD PhD | Maastricht University | |
| Principal Investigator: | Willem Jan Van Weelden, MD | Radboud University Medical Center |
Publications:
| Responsible Party: | Radboud University Medical Center |
| ClinicalTrials.gov Identifier: | NCT03621904 |
| Other Study ID Numbers: |
2017-3803 |
| First Posted: | August 9, 2018 Key Record Dates |
| Last Update Posted: | January 18, 2023 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | This is not yet established |
| 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 |
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Hormonal therapy Endocrine therapy Translational research Tumor factors |
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Endometrial Neoplasms Recurrence Disease Attributes Pathologic Processes Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Tamoxifen Antineoplastic Agents, Hormonal Antineoplastic Agents Progesterone |
Aromatase Inhibitors Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Estrogen Antagonists Hormone Antagonists Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |