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Endometrial Cancer Stage IIIPROMOTENCT03621904

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

An observational study of Endometrial Cancer Stage III and Endometrial Cancer Stage IV, run by Radboud University Medical Center at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 110 years, women only
What is being tested?
Hormonal Antineoplastics
How many people
150 participants
Where
1 siteNetherlands
Study dates
15 Oct 2022to 1 Sep 2027
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hanny Pijnenborg, MD PhD contact

+31243616683

Netherlands1 site, 1 recruiting
  • Radboudumc

    Nijmegen, 6525GA

    Maartje Luijten, Maartje.luijten@radboudumc.nl

    Hanny Pijnenborg, Hanny.ma.pijnenborg@radboudumc.nl

    Recruiting

Other trials in Netherlands

About this study

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

Read the 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

Being tested
Hormonal Antineoplastics
Keywords
Hormonal therapy, Endocrine therapy, Translational research, Tumor factors
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hormonal AntineoplasticsDrug

    Also called Progesterone, Tamoxifen, Aromatase inhibitors

    Hormonal therapy used for treatment in endometrial cancer patients

Study groups in NCT03621904
Study groupRoleWhat they receive
EC patients with HTPatients with advanced stage or recurrent endometrial cancer treated with hormonal therapy
Receives: Drug: Hormonal Antineoplastics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Complete or partial response according to RECIST criteria

    Measured: 2 years

  2. Progression free survival

    Interval from start of hormonal therapy to progressive disease or death

    Measured: 2 years

  3. Clinical benefit rate

    Complete or partial response or stable disease according to RECIST criteria

    Measured: 2 years

Secondary outcomes (1)
  1. Health-related quality of life

    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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2018
  2. Study start15 Oct 2022
  3. Primary completion15 Oct 2026 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03621904
Sponsor's protocol ID
2017-3803
Acronym
PROMOTE
Status last verified
Oct 2022
First submitted
6 Aug 2018
Last updated
18 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: This is not yet established

Publications

  • Amant F, Mirza MR, Koskas M, Creutzberg CL. Cancer of the corpus uteri. Int J Gynaecol Obstet. 2015 Oct;131 Suppl 2:S96-104. doi: 10.1016/j.ijgo.2015.06.005. No abstract available.

    PubMed 26433681
  • Moore TD, Phillips PH, Nerenstone SR, Cheson BD. Systemic treatment of advanced and recurrent endometrial carcinoma: current status and future directions. J Clin Oncol. 1991 Jun;9(6):1071-88. doi: 10.1200/JCO.1991.9.6.1071.

    PubMed 2033421
  • Fleming GF, Brunetto VL, Cella D, Look KY, Reid GC, Munkarah AR, Kline R, Burger RA, Goodman A, Burks RT. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2004 Jun 1;22(11):2159-66. doi: 10.1200/JCO.2004.07.184.

    PubMed 15169803
  • Decruze SB, Green JA. Hormone therapy in advanced and recurrent endometrial cancer: a systematic review. Int J Gynecol Cancer. 2007 Sep-Oct;17(5):964-78. doi: 10.1111/j.1525-1438.2007.00897.x. Epub 2007 Apr 18.

    PubMed 17442022
  • Ethier JL, Desautels DN, Amir E, MacKay H. Is hormonal therapy effective in advanced endometrial cancer? A systematic review and meta-analysis. Gynecol Oncol. 2017 Oct;147(1):158-166. doi: 10.1016/j.ygyno.2017.07.002. Epub 2017 Jul 6.

    PubMed 28689667
  • Colombo N, Creutzberg C, Amant F, Bosse T, Gonzalez-Martin A, Ledermann J, Marth C, Nout R, Querleu D, Mirza MR, Sessa C; ESMO-ESGO-ESTRO Endometrial Consensus Conference Working Group. ESMO-ESGO-ESTRO Consensus Conference on Endometrial Cancer: Diagnosis, Treatment and Follow-up. Int J Gynecol Cancer. 2016 Jan;26(1):2-30. doi: 10.1097/IGC.0000000000000609.

    PubMed 26645990
  • Gibson WJ, Hoivik EA, Halle MK, Taylor-Weiner A, Cherniack AD, Berg A, Holst F, Zack TI, Werner HM, Staby KM, Rosenberg M, Stefansson IM, Kusonmano K, Chevalier A, Mauland KK, Trovik J, Krakstad C, Giannakis M, Hodis E, Woie K, Bjorge L, Vintermyr OK, Wala JA, Lawrence MS, Getz G, Carter SL, Beroukhim R, Salvesen HB. The genomic landscape and evolution of endometrial carcinoma progression and abdominopelvic metastasis. Nat Genet. 2016 Aug;48(8):848-55. doi: 10.1038/ng.3602. Epub 2016 Jun 27.

    PubMed 27348297
  • Vandenput I, Trovik J, Leunen K, Wik E, Stefansson I, Akslen L, Moerman P, Vergote I, Salvesen H, Amant F. Evolution in endometrial cancer: evidence from an immunohistochemical study. Int J Gynecol Cancer. 2011 Feb;21(2):316-22. doi: 10.1097/IGC.0b013e31820575f5.

    PubMed 21734474
  • Tangen IL, Onyango TB, Kopperud R, Berg A, Halle MK, Oyan AM, Werner HM, Trovik J, Kalland KH, Salvesen HB, Krakstad C. Androgen receptor as potential therapeutic target in metastatic endometrial cancer. Oncotarget. 2016 Aug 2;7(31):49289-49298. doi: 10.18632/oncotarget.10334.

    PubMed 27384477
  • Verhaegh W, van Ooijen H, Inda MA, Hatzis P, Versteeg R, Smid M, Martens J, Foekens J, van de Wiel P, Clevers H, van de Stolpe A. Selection of personalized patient therapy through the use of knowledge-based computational models that identify tumor-driving signal transduction pathways. Cancer Res. 2014 Jun 1;74(11):2936-45. doi: 10.1158/0008-5472.CAN-13-2515. Epub 2014 Apr 2.

    PubMed 24695361
  • Cornel KM, Kruitwagen RF, Delvoux B, Visconti L, Van de Vijver KK, Day JM, Van Gorp T, Hermans RJ, Dunselman GA, Romano A. Overexpression of 17beta-hydroxysteroid dehydrogenase type 1 increases the exposure of endometrial cancer to 17beta-estradiol. J Clin Endocrinol Metab. 2012 Apr;97(4):E591-601. doi: 10.1210/jc.2011-2994. Epub 2012 Feb 22.

    PubMed 22362820
  • Cornel KM, Krakstad C, Delvoux B, Xanthoulea S, Jori B, Bongers MY, Konings GF, Kooreman LF, Kruitwagen RF, Salvesen HB; ENITEC; Romano A. High mRNA levels of 17beta-hydroxysteroid dehydrogenase type 1 correlate with poor prognosis in endometrial cancer. Mol Cell Endocrinol. 2017 Feb 15;442:51-57. doi: 10.1016/j.mce.2016.11.030. Epub 2016 Dec 5.

    PubMed 27923582

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrial Cancer Stage III and Endometrial Cancer Stage IV, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maartje Luijten, MD (+31243616683, Maartje.luijten@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03621904, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.

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