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

NCT03621904 | Recruiting

• 1 other identifier: 2017-3803
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Endometrial Cancer Stage III; Endometrial Cancer Stage IV; Endometrial Cancer Recurrent

Keywords

Hormonal therapy; Endocrine therapy; Translational research; Tumor factors

Outcome Measures

Primary Outcomes (3)

• Response rate

  Complete or partial response according to RECIST criteria

  2 years

• Progression free survival

  Interval from start of hormonal therapy to progressive disease or death

  2 years

• Clinical benefit rate

  Complete or partial response or stable disease according to RECIST criteria

  2 years

Secondary Outcomes (1)

• Health-related quality of life

  6 months

Study Arms (1)

EC patients with HT

Patients with advanced stage or recurrent endometrial cancer treated with hormonal therapy

Drug: Hormonal Antineoplastics

Interventions

Hormonal Antineoplastics DRUG

Hormonal therapy used for treatment in endometrial cancer patients

Also known as: Progesterone, Tamoxifen, Aromatase inhibitors

EC patients with HT

Eligibility Criteria

• Age: 18 Years - 110 Years
• Gender Eligibility Details: Endometrial cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Radboudumc

Nijmegen, 6525GA, Netherlands

RECRUITING

Related 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.

  PMID: 26433681 BACKGROUND

• 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.

  PMID: 2033421 BACKGROUND

• 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.

  PMID: 15169803 BACKGROUND

• 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.

  PMID: 17442022 BACKGROUND

• 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.

  PMID: 28689667 BACKGROUND

• 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.

  PMID: 26645990 BACKGROUND

• 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.

  PMID: 27348297 BACKGROUND

• 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.

  PMID: 21734474 BACKGROUND

• 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.

  PMID: 27384477 BACKGROUND

• 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.

  PMID: 24695361 BACKGROUND

• 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.

  PMID: 22362820 BACKGROUND

• 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.

  PMID: 27923582 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples originating from before start of hormonal therapy

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Antineoplastic Agents, Hormonal; Progesterone; Tamoxifen; Aromatase Inhibitors

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antineoplastic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maartje Luijten, MD

CONTACT

+31243616683; Maartje.luijten@radboudumc.nl

Hanny Pijnenborg, MD PhD

CONTACT

+31243616683

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 9, 2018
• Study Start: October 15, 2022
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 18, 2023

Record last verified: 2022-10

Locations

NL (1)