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

BackgroundEndometrial 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...

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Published inInternational journal of gynecological cancer Vol. 33; no. 11; pp. 1807 - 1811
Main Authors Loukovaara, Mikko, Bützow, Ralf, Staff, Synnöve, Mäenpää, Minna, Faltinová, Mária, Lassus, Heini, Veijalainen, Olga, Grönvall, Maiju, Vaalavirta, Leila, Kuikka, Elina, Haataja, Marjut, Urpilainen, Elina, Simojoki, Marja, Anttila, Maarit, Auranen, Annika
Format Journal Article
LanguageEnglish
Published United States BMJ Publishing Group Ltd 01.11.2023
Elsevier Inc
Elsevier Limited
Subjects
Cancer therapies
Carcinoma - pathology
Chemotherapy
Clinical trial
Endometrial cancer
Endometrial Neoplasms - pathology
Endometrium
Female
Finland
Gynecology
Humans
Hysterectomy
Neoplasm Recurrence, Local - pathology
Neoplasm Staging
Obstetrics
Oncology
Oophorectomy
Pathology
Patients
Precision Medicine
Prospective Studies
Quality of life
Radiation therapy
Retrospective Studies
Society
Surgery
Toxicity
Tumors
Uterine Cancer
Vagina
Yeast
Finland
Uterine Cancer
Endometrium
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Abstract BackgroundEndometrial 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 ObjectiveThe 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 HypothesisCompared 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 DesignThis 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 CriteriaWomen with stages I–II molecular integrated high-intermediate risk or high-risk endometrial carcinoma will be included.Primary EndpointThe primary endpoint is the 5 year cumulative incidence of disease recurrence.Sample SizeA 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 ResultsPatient recruitment will be completed in 2025, and follow-up will be completed in 2030.Trial Registration NCT05655260.
AbstractList 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. 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. 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. 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. Women with stages I–II molecular integrated high-intermediate risk or high-risk endometrial carcinoma will be included. The primary endpoint is the 5 year cumulative incidence of disease recurrence. 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. Patient recruitment will be completed in 2025, and follow-up will be completed in 2030. NCT05655260.
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.BACKGROUNDEndometrial 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.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.PRIMARY OBJECTIVEThe 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.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.STUDY HYPOTHESISCompared 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.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.TRIAL DESIGNThis 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.Women with stages I-II molecular integrated high-intermediate risk or high-risk endometrial carcinoma will be included.MAJOR INCLUSION/EXCLUSION CRITERIAWomen with stages I-II molecular integrated high-intermediate risk or high-risk endometrial carcinoma will be included.The primary endpoint is the 5 year cumulative incidence of disease recurrence.PRIMARY ENDPOINTThe primary endpoint is the 5 year cumulative incidence of disease recurrence.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.SAMPLE SIZEA total sample size of 294 patients (49 subjects in each treatment arm of the three subgroups intended for randomization) was estimated to be sufficient.Patient recruitment will be completed in 2025, and follow-up will be completed in 2030.ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTSPatient recruitment will be completed in 2025, and follow-up will be completed in 2030.NCT05655260.TRIAL REGISTRATIONNCT05655260.
BackgroundEndometrial 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 ObjectiveThe 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 HypothesisCompared 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 DesignThis 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 CriteriaWomen with stages I–II molecular integrated high-intermediate risk or high-risk endometrial carcinoma will be included.Primary EndpointThe primary endpoint is the 5 year cumulative incidence of disease recurrence.Sample SizeA 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 ResultsPatient recruitment will be completed in 2025, and follow-up will be completed in 2030.Trial Registration NCT05655260.
BackgroundEndometrial 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 ObjectiveThe 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 HypothesisCompared 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 DesignThis 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 CriteriaWomen with stages I–II molecular integrated high-intermediate risk or high-risk endometrial carcinoma will be included.Primary EndpointThe primary endpoint is the 5 year cumulative incidence of disease recurrence.Sample SizeA 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 ResultsPatient recruitment will be completed in 2025, and follow-up will be completed in 2030.Trial RegistrationNCT05655260.
Endometrial carcinomas can be classified into four molecular subgroups - mismatch repair deficient (MMRd), p53 abnormal (p53abn), polymerase-ϵ ( ) 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. 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. 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. ultramutated carcinomas harboring high-intermediate or high-risk clinicopathologic features are speculated to have favorable prognosis without any adjuvant therapy. 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. Women with stages I-II molecular integrated high-intermediate risk or high-risk endometrial carcinoma will be included. The primary endpoint is the 5 year cumulative incidence of disease recurrence. 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. Patient recruitment will be completed in 2025, and follow-up will be completed in 2030. NCT05655260.
Author Vaalavirta, Leila
Faltinová, Mária
Haataja, Marjut
Simojoki, Marja
Veijalainen, Olga
Anttila, Maarit
Loukovaara, Mikko
Staff, Synnöve
Auranen, Annika
Lassus, Heini
Grönvall, Maiju
Bützow, Ralf
Kuikka, Elina
Urpilainen, Elina
Mäenpää, Minna
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Issue 11
Keywords Uterine Cancer
Endometrium
Language English
License http://creativecommons.org/licenses/by-nc-nd/4.0
IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.
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Snippet BackgroundEndometrial carcinomas can be classified into four molecular subgroups – mismatch repair deficient (MMRd), p53 abnormal (p53abn), polymerase-ϵ (POLE)...
Endometrial carcinomas can be classified into four molecular subgroups – mismatch repair deficient (MMRd), p53 abnormal (p53abn), polymerase-ϵ (POLE)...
Endometrial carcinomas can be classified into four molecular subgroups - mismatch repair deficient (MMRd), p53 abnormal (p53abn), polymerase-ϵ ( )...
Endometrial carcinomas can be classified into four molecular subgroups - mismatch repair deficient (MMRd), p53 abnormal (p53abn), polymerase-ϵ (POLE)...
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StartPage 1807
SubjectTerms Cancer therapies
Carcinoma - pathology
Chemotherapy
Clinical trial
Endometrial cancer
Endometrial Neoplasms - pathology
Endometrium
Female
Finland
Gynecology
Humans
Hysterectomy
Neoplasm Recurrence, Local - pathology
Neoplasm Staging
Obstetrics
Oncology
Oophorectomy
Pathology
Patients
Precision Medicine
Prospective Studies
Quality of life
Radiation therapy
Retrospective Studies
Society
Surgery
Toxicity
Tumors
Uterine Cancer
Vagina
Yeast
Title PErsonalized TReatment for Endometrial Carcinoma (PETREC): study design and methods of a prospective Finnish multicenter trial
URI https://ijgc.bmj.com/content/33/11/1807.full
https://dx.doi.org/10.1136/ijgc-2023-004939
https://www.ncbi.nlm.nih.gov/pubmed/37813479
https://www.proquest.com/docview/2874507457
https://www.proquest.com/docview/2886418846
https://www.proquest.com/docview/2878019662
Volume 33
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