PErsonalized TReatment for Endometrial Carcinoma

Endometrial Adenocarcinoma Clinical Trial

— PETREC  

Official title:

PErsonalized TReatment for Endometrial Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05655260
• Other study ID #: HUS/2360/2021
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2022
• Source: University of Helsinki
• Contact: Mikko Loukovaara
• Phone: +358504272526
• Email: mikko.loukovaara[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Adenocarcinoma
• Endometrial Neoplasms

Intervention

Other:
• Comparison of adjuvant therapies
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).
• Comparison of adjuvant therapies
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).

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (8)

Lead Sponsor	Collaborator
University of Helsinki	Kuopio University Hospital, Kymenlaakso Central Hospital Kotka Finland, Oulu University Hospital, Päijät-Häme Central Hospital, South Carelia Central Hospital, Tampere University Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer reappearance	Cumulative incidence of disease recurrence	5 years
Secondary	Location of cancer reappearance	Vaginal, pelvic, and distant recurrence rates	5 years
Secondary	Overall survival	The time from surgery to death	5 years
Secondary	Recurrence-free survival	The time from surgery to cancer recurrence	5 years
Secondary	Adverse events	Adjuvant therapy-related adverse events	5 years