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

Endometrial Cancer Recurrent Clinical Trial

— PROMOTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03621904
• Other study ID #: 2017-3803
• Status: Recruiting
• Start date: October 15, 2022
• Est. completion date: September 1, 2027

Study information

• Verified date: October 2022
• Source: Radboud University Medical Center
• Contact: Maartje Luijten, MD
• Phone: +31243616683
• Email: Maartje.luijten[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 1, 2027
• Est. primary completion date: October 15, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer Recurrent
• Endometrial Cancer Stage III
• Endometrial Cancer Stage IV
• Endometrial Neoplasms
• Recurrence

Intervention

Drug:
• Hormonal Antineoplastics
Hormonal therapy used for treatment in endometrial cancer patients

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (15)

Lead Sponsor

Collaborator

Radboud University Medical Center

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

Country where clinical trial is conducted

Netherlands, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Complete or partial response according to RECIST criteria	2 years
Primary	Progression free survival	Interval from start of hormonal therapy to progressive disease or death	2 years
Primary	Clinical benefit rate	Complete or partial response or stable disease according to RECIST criteria	2 years
Secondary	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	6 months