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PErsonalized TReatment for Endometrial Carcinoma (PETREC)

Primary Purpose

Endometrial Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Comparison of adjuvant therapies
Comparison of adjuvant therapies
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Adenocarcinoma focused on measuring Endometrial carcinoma, Molecular classification, Adjuvant therapy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Helsinki University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

p53 abn subtype and nonendometrioid carcinomas

MMR-D molecular subgroup

NSMP molecular subgroup

Arm Description

p53 abn stage I-II MI (myometrial invasion) >0%; MMR-D/NSMP nonendometrioid stage I-II MI >0%

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;

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;

Outcomes

Primary Outcome Measures

Cancer reappearance
Cumulative incidence of disease recurrence

Secondary Outcome Measures

Location of cancer reappearance
Vaginal, pelvic, and distant recurrence rates
Overall survival
The time from surgery to death
Recurrence-free survival
The time from surgery to cancer recurrence
Adverse events
Adjuvant therapy-related adverse events

Full Information

First Posted
November 30, 2022
Last Updated
December 8, 2022
Sponsor
University of Helsinki
Collaborators
Päijät Häme Central Hospital, South Carelia Central Hospital, Kymenlaakso Central Hospital Kotka Finland, Turku University Hospital, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05655260
Brief Title
PErsonalized TReatment for Endometrial Carcinoma
Acronym
PETREC
Official Title
PErsonalized TReatment for Endometrial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
Collaborators
Päijät Häme Central Hospital, South Carelia Central Hospital, Kymenlaakso Central Hospital Kotka Finland, Turku University Hospital, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Adenocarcinoma
Keywords
Endometrial carcinoma, Molecular classification, Adjuvant therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comprehensive cohort design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
p53 abn subtype and nonendometrioid carcinomas
Arm Type
Experimental
Arm Description
p53 abn stage I-II MI (myometrial invasion) >0%; MMR-D/NSMP nonendometrioid stage I-II MI >0%
Arm Title
MMR-D molecular subgroup
Arm Type
Experimental
Arm 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;
Arm Title
NSMP molecular subgroup
Arm Type
Experimental
Arm 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;
Intervention Type
Other
Intervention Name(s)
Comparison of adjuvant therapies
Intervention Description
Chemotherapy (paclitaxel-carboplatin) vs. chemoradiotherapy (paclitaxel-carboplatin followed by whole pelvic radiotherapy) Patients 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).
Intervention Type
Other
Intervention Name(s)
Comparison of adjuvant therapies
Intervention Description
Vaginal brachytherapy vs. whole pelvic radiotherapy Patients 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).
Primary Outcome Measure Information:
Title
Cancer reappearance
Description
Cumulative incidence of disease recurrence
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Location of cancer reappearance
Description
Vaginal, pelvic, and distant recurrence rates
Time Frame
5 years
Title
Overall survival
Description
The time from surgery to death
Time Frame
5 years
Title
Recurrence-free survival
Description
The time from surgery to cancer recurrence
Time Frame
5 years
Title
Adverse events
Description
Adjuvant therapy-related adverse events
Time Frame
5 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Eligibility not based on self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikko Loukovaara
Phone
+358504272526
Email
mikko.loukovaara@hus.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Ralf Bützow
Phone
+358504271899
Email
ralf.butzow@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikko Loukovaara
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikko Loukovaara, MD
Phone
+358504272526
Email
mikko.loukovaara@hus.fi
First Name & Middle Initial & Last Name & Degree
Ralf Bützow, MD
Phone
+358504271899
Email
ralf.butzow@hus.fi

12. IPD Sharing Statement

Plan to Share IPD
No

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PErsonalized TReatment for Endometrial Carcinoma

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