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  • PErsonalized TReatment for Endometrial Carcinoma (PETREC): study design and methods of a prospective Finnish multicenter trial

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Clinical trial
PErsonalized TReatment for Endometrial Carcinoma (PETREC): study design and methods of a prospective Finnish multicenter trial
  1. Mikko Loukovaara1,
  2. Ralf Bützow2,
  3. Synnöve Staff3,
  4. Minna Mäenpää3,
  5. Mária Faltinová4,
  6. Heini Lassus1,
  7. Olga Veijalainen5,
  8. Maiju Grönvall6,
  9. Leila Vaalavirta7,
  10. Elina Kuikka8,
  11. Marjut Haataja9,
  12. Elina Urpilainen10,
  13. Marja Simojoki10,
  14. Maarit Anttila11 and
  15. Annika Auranen3
  1. 1 Department of Obstetrics and Gynecology and Comprehensive Cancer Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
  2. 2 Department of Pathology, Helsinki University Hospital and Research Program in Applied Tumor Genomics, Faculty of Medicine, University of Helsinki, Helsinki, Finland
  3. 3 Department of Obstetrics and Gynecology, Tampere University Hospital, Wellbeing Services County of Pirkanmaa and FICAN Mid Cancer Center, Tampere, Finland, and Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland
  4. 4 Comprehensive Cancer Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
  5. 5 Department of Obstetrics and Gynecology, Wellbeing Services County of Päijät-Häme, Lahti, Finland
  6. 6 Department of Obstetrics and Gynecology, Wellbeing Services County of Kymenlaakso, Kotka, Finland
  7. 7 Department of Radiation Oncology, Wellbeing Services County of Kymenlaakso, Kotka, Finland
  8. 8 Department of Obstetrics and Gynecology, Wellbeing Services County of South Karelia, Lappeenranta, Finland
  9. 9 Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland
  10. 10 Department of Obstetrics and Gynecology, Medical Research Center, Oulu University Hospital, Oulu, Finland
  11. 11 Department of Obstetrics and Gynecology, Wellbeing Services County of North Savo and Kuopio University Hospital, Kuopio, Finland
  1. Correspondence to Dr Mikko Loukovaara, Department of Obstetrics and Gynecology and Comprehensive Cancer Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland; mikko.loukovaara{at}hus.fi

Abstract

Background Endometrial carcinomas can be classified into four molecular subgroups – mismatch repair deficient (MMRd), p53 abnormal (p53abn), polymerase-ϵ (POLE) ultramutated, and ‘no specific molecular profile’ (NSMP). Retrospective data imply that the response to adjuvant therapies may depend on the molecular subgroup. These findings emphasize the need for adjuvant therapy trials where patients are randomized to treatment arms separately within each molecular subgroup.

Primary Objective The PErsonalized TReatment for Endometrial Carcinoma (PETREC) trial clarifies the value of molecular classification in the determination of adjuvant therapies of high-intermediate risk and early-stage high-risk endometrial carcinoma.

Study Hypothesis Compared with vaginal brachytherapy, the utilization of whole pelvic radiotherapy may result in improved outcomes for either MMRd or NSMP high-intermediate risk carcinomas. Early-stage high-risk p53abn and nonendometrioid carcinomas are postulated to gain benefits from chemoradiotherapy, as opposed to chemotherapy alone. POLE ultramutated carcinomas harboring high-intermediate or high-risk clinicopathologic features are speculated to have favorable prognosis without any adjuvant therapy.

Trial Design This prospective, multicenter, phase 3 trial compares the efficacy of vaginal brachytherapy vs whole pelvic radiotherapy in high-intermediate risk MMRd and NSMP molecular subgroups, and chemotherapy vs chemoradiotherapy in early-stage high-risk p53abn subtype and nonendometrioid carcinomas. Eligible women who consent to participation in the trial are randomly allocated (1:1) to treatment arms.

Major Inclusion/Exclusion Criteria Women with stages I–II molecular integrated high-intermediate risk or high-risk endometrial carcinoma will be included.

Primary Endpoint The primary endpoint is the 5 year cumulative incidence of disease recurrence.

Sample Size A total sample size of 294 patients (49 subjects in each treatment arm of the three subgroups intended for randomization) was estimated to be sufficient.

Estimated Dates for Completing Accrual and Presenting Results Patient recruitment will be completed in 2025, and follow-up will be completed in 2030.

Trial Registration NCT05655260.

  • Uterine Cancer
  • Endometrium

Data availability statement

All data relevant to the study are included in the article.

https://doi.org/10.1136/ijgc-2023-004939

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    Data availability statement

    All data relevant to the study are included in the article.

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    Footnotes

    • Contributors ML wrote the manuscript with input from all authors. All authors contributed to the study conception and design. ML was in charge of the overall direction and planning, and is responsible for the overall content as guarantor.

    • Funding The study received funding from HUS FICAN South (M2118PETRE).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.