PErsonalized TReatment for Endometrial Carcinoma

NCT05655260 | Recruiting

• 1 other identifier: HUS/2360/2021
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Adenocarcinoma

Keywords

Endometrial carcinoma; Molecular classification; Adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Cancer reappearance

  Cumulative incidence of disease recurrence

  5 years

Secondary Outcomes (4)

• Location of cancer reappearance

  5 years

• Overall survival

  5 years

• Recurrence-free survival

  5 years

• Adverse events

  5 years

Study Arms (3)

p53 abn subtype and nonendometrioid carcinomas

EXPERIMENTAL

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

Other: Comparison of chemotherapy vs. chemoradiotherapy

MMR-D molecular subgroup

EXPERIMENTAL

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;

Other: Comparison of VBT vs. WPRT

NSMP molecular subgroup

EXPERIMENTAL

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;

Other: Comparison of VBT vs. WPRT

Interventions

Comparison of chemotherapy vs. chemoradiotherapy OTHER

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).

p53 abn subtype and nonendometrioid carcinomas

Comparison of VBT vs. WPRT OTHER

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).

MMR-D molecular subgroup; NSMP molecular subgroup

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Eligibility not based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Helsinki: lead
• Turku University Hospital: collaborator
• Tampere University Hospital: collaborator
• Kuopio University Hospital: collaborator
• Oulu University Hospital: collaborator
• Kymenlaakso Central Hospital Kotka Finland: collaborator
• Päijänne Tavastia Central Hospital: collaborator
• South Carelia Central Hospital: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, 00290, Finland

RECRUITING

Related Publications (1)

• 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.

  PMID: 37813479 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mikko Loukovaara

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikko Loukovaara

CONTACT

+358504272526; mikko.loukovaara@hus.fi

Ralf Bützow

CONTACT

+358504271899; ralf.butzow@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Specialists, MD

Model Details: Comprehensive cohort design

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 19, 2022
• Study Start: February 8, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)