Clinical trial NCT05655260: PErsonalized TReatment for Endometrial Carcinoma
Official title: PErsonalized TReatment for Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Adenocarcinoma
Keywords: Endometrial carcinoma
Molecular classification
Adjuvant therapy
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: Tampere University Hospital
name: Kuopio University Hospital
name: Oulu University Hospital
name: Kymenlaakso Central Hospital Kotka Finland
name: Päijänne Tavastia Central Hospital
name: South Carelia Central Hospital
First posted: 2022-12-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comprehensive cohort design
Primary purpose: TREATMENT

Brief summary: 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:

* Chemotherapy vs. chemoradiotherapy in p53 abn subtype and nonendometrioid carcinomas.
* Vaginal brachytherapy vs. whole pelvic radiotherapy in the MMR-D molecular subgroup.
* Vaginal brachytherapy vs. whole pelvic radiotherapy in the NSMP molecular subgroup.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 100 years
* WHO performance status 0 to 2
* Stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma

Exclusion Criteria:

* Age \<18 years or \>100 years
* WHO performance status \>2
* Uterine sarcoma
* A history of malignancy within 5 years
* Previous pelvic radiotherapy
* 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)

Primary outcomes:
measure: Cancer reappearance
timeFrame: 5 years
Secondary outcomes:
measure: Location of cancer reappearance
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Recurrence-free survival
timeFrame: 5 years
measure: Adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Mikko Loukovaara
role: PRINCIPAL_INVESTIGATOR
References: