Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT05655260
Status:
RECRUITING
Last Update Posted:
2024-12-06
First Post:
2022-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PErsonalized TReatment for Endometrial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comprehensive cohort design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2022-12-08', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer reappearance', 'timeFrame': '5 years', 'description': 'Cumulative incidence of disease recurrence'}], 'secondaryOutcomes': [{'measure': 'Location of cancer reappearance', 'timeFrame': '5 years', 'description': 'Vaginal, pelvic, and distant recurrence rates'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'The time from surgery to death'}, {'measure': 'Recurrence-free survival', 'timeFrame': '5 years', 'description': 'The time from surgery to cancer recurrence'}, {'measure': 'Adverse events', 'timeFrame': '5 years', 'description': 'Adjuvant therapy-related adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometrial carcinoma', 'Molecular classification', 'Adjuvant therapy'], 'conditions': ['Endometrial Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '37813479', 'type': 'DERIVED', 'citation': 'Loukovaara M, Butzow R, Staff S, Maenpaa M, Faltinova M, Lassus H, Veijalainen O, Gronvall M, Vaalavirta L, Kuikka E, Haataja M, Urpilainen E, Simojoki M, Anttila M, Auranen A. PErsonalized TReatment for Endometrial Carcinoma (PETREC): study design and methods of a prospective Finnish multicenter trial. Int J Gynecol Cancer. 2023 Nov 6;33(11):1807-1811. doi: 10.1136/ijgc-2023-004939.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the efficacy of adjuvant therapies in women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. Specifically, the invesigators want to compare:\n\n* Chemotherapy vs. chemoradiotherapy in p53 abn subtype and nonendometrioid carcinomas.\n* Vaginal brachytherapy vs. whole pelvic radiotherapy in the MMR-D molecular subgroup.\n* Vaginal brachytherapy vs. whole pelvic radiotherapy in the NSMP molecular subgroup.', 'detailedDescription': 'Endometrial carcinomas can be classified into four molecular subgroups, i.e. mismatch repair deficient (MMR-D), p53 abnormal (p53 abn), polymerase-ϵ (POLE) ultramutated, and "no specific molecular profile" (NSMP). Molecular subgroups can be considered to be distinct diseases as they are associated with different clinicopathologic characteristics, prognoses and, possibly, responses to adjuvant therapy. Molecular classification of endometrial carcinoma is recommended to be implemented in routine clinical practice to improve prognostication and triage to adjuvant therapy. The PErsonalized TReatment for Endometrial Carcinoma (PETREC) trial, led by the Finnish Gynecologic Oncology Group (FINGOG), is a multicenter prospective clinical trial for women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. The efficacy of chemotherapy vs. chemoradiotherapy is compared in p53 abn subtype and nonendometrioid carcinomas, and vaginal brachytherapy vs. whole pelvic radiotherapy in MMR-D and NSMP molecular subgroups. Patients who consent to follow-up within the trial but not to randomization are treated as recommended in multidisciplinary meetings and enrolled for follow-up only (comprehensive cohort study design). The primary outcome is the 5-year cumulative incidence of disease recurrence. Secondary outcomes are vaginal, pelvic, and distant recurrence rates, 5-year recurrence-free and overall survival, adverse events, and patient-reported symptoms and quality of life. The findings of the trial may eventually help decrease under- and overtreatment and, consequently, improve patient outcome and decrease treatment-associated adverse effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Eligibility not based on self-representation of gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 100 years\n* WHO performance status 0 to 2\n* Stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma\n\nExclusion Criteria:\n\n* Age \\<18 years or \\>100 years\n* WHO performance status \\>2\n* Uterine sarcoma\n* A history of malignancy within 5 years\n* Previous pelvic radiotherapy\n* An interval of \\>30 days between surgery and start of chemotherapy or \\>8 weeks between surgery and start of radiotherapy (longer intervals may be permitted with investigator´s approval)'}, 'identificationModule': {'nctId': 'NCT05655260', 'acronym': 'PETREC', 'briefTitle': 'PErsonalized TReatment for Endometrial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Helsinki'}, 'officialTitle': 'PErsonalized TReatment for Endometrial Carcinoma', 'orgStudyIdInfo': {'id': 'HUS/2360/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'p53 abn subtype and nonendometrioid carcinomas', 'description': 'p53 abn stage I-II MI (myometrial invasion) \\>0%; MMR-D/NSMP nonendometrioid stage I-II MI \\>0%', 'interventionNames': ['Other: Comparison of chemotherapy vs. chemoradiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'MMR-D molecular subgroup', 'description': 'MMR-D stage IA-B grade 1-2, substantial LVSI; MMR-D stage IA grade 3, substantial LVSI; MMR-D stage IB grade 3; MMR-D stage II grade 1-3;', 'interventionNames': ['Other: Comparison of VBT vs. WPRT']}, {'type': 'EXPERIMENTAL', 'label': 'NSMP molecular subgroup', 'description': 'NSMP stage IA-B grade 1-2, substantial LVSI; NSMP stage IA grade 3, substantial LVSI; NSMP stage IB grade 3; NSMP stage II grade 1-3;', 'interventionNames': ['Other: Comparison of VBT vs. WPRT']}], 'interventions': [{'name': 'Comparison of chemotherapy vs. chemoradiotherapy', 'type': 'OTHER', 'description': 'Chemotherapy (paclitaxel-carboplatin) vs. chemoradiotherapy (paclitaxel-carboplatin followed by whole pelvic radiotherapy)\n\nPatients assigned to chemotherapy receive paclitaxel (175 mg/m2) and carboplatin (area under curve, 5) every 3 weeks for 6 cycles. The pelvic radiotherapy dose is 45 to 50.4 Gy over 5 to 6 weeks (1.8 Gy per day for 25 to 28 fractions).', 'armGroupLabels': ['p53 abn subtype and nonendometrioid carcinomas']}, {'name': 'Comparison of VBT vs. WPRT', 'type': 'OTHER', 'description': 'Vaginal brachytherapy vs. whole pelvic radiotherapy\n\nPatients randomized to vaginal brachytherapy receive cuff brachytherapy at 21 Gy in 3 fractions of 7 Gy at 0.5 cm depth. The pelvic radiotherapy dose is 45 to 50.4 Gy over 5 to 6 weeks (1.8 Gy per day for 25 to 28 fractions).', 'armGroupLabels': ['MMR-D molecular subgroup', 'NSMP molecular subgroup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00290', 'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Mikko Loukovaara, MD', 'role': 'CONTACT', 'email': 'mikko.loukovaara@hus.fi', 'phone': '+358504272526'}, {'name': 'Ralf Bützow, MD', 'role': 'CONTACT', 'email': 'ralf.butzow@hus.fi', 'phone': '+358504271899'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Mikko Loukovaara', 'role': 'CONTACT', 'email': 'mikko.loukovaara@hus.fi', 'phone': '+358504272526'}, {'name': 'Ralf Bützow', 'role': 'CONTACT', 'email': 'ralf.butzow@hus.fi', 'phone': '+358504271899'}], 'overallOfficials': [{'name': 'Mikko Loukovaara', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Helsinki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, {'name': 'Tampere University Hospital', 'class': 'OTHER'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, {'name': 'Oulu University Hospital', 'class': 'OTHER'}, {'name': 'Kymenlaakso Central Hospital Kotka Finland', 'class': 'OTHER'}, {'name': 'Päijänne Tavastia Central Hospital', 'class': 'OTHER'}, {'name': 'South Carelia Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Specialists, MD', 'investigatorFullName': 'Mikko Loukovaara', 'investigatorAffiliation': 'University of Helsinki'}}}}