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PErsonalized TReatment for Endometrial Carcinoma

NCT05655260RecruitingNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

University of Helsinki

Enrollment

300

Start Date

2022-02-08

Completion Date

2028-12-31

Study Type

INTERVENTIONAL

Official Title

PErsonalized TReatment for Endometrial Carcinoma

Interventions

Comparison of chemotherapy vs. chemoradiotherapyComparison of VBT vs. WPRT

Conditions

Endometrial Adenocarcinoma

Eligibility

Age Range

18 Years – 100 Years

Sex

FEMALE

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)

Outcome Measures

Primary Outcomes

Cancer reappearance

Cumulative incidence of disease recurrence

Time frame: 5 years

Secondary Outcomes

Location of cancer reappearance

Vaginal, pelvic, and distant recurrence rates

Time frame: 5 years

Overall survival

The time from surgery to death

Time frame: 5 years

Recurrence-free survival

The time from surgery to cancer recurrence

Time frame: 5 years

Adverse events

Adjuvant therapy-related adverse events

Time frame: 5 years

Locations

Helsinki University Hospital, Helsinki, Finland

Linked Papers

2023-11-06

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

Endometrial carcinomas can be classified into four molecular subgroups - mismatch repair deficient (MMRd), p53 abnormal (p53abn), polymerase-ϵ ( 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. 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.

Linked Investigators

Mikko Loukovaara