Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
FEMALE
ID05655260

Personalized Treatment for Endometrial Carcinoma Comparing Chemotherapy, Chemoradiotherapy, and Radiotherapy by Molecular Subtypes

Led by University of Helsinki ยท Updated on 2024-12-06

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Helsinki

Lead Sponsor

T

Turku University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating different adjuvant therapies for women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. This trial focuses on comparing treatments based on specific molecular subgroups of the cancer, including p53 abnormal, mismatch repair deficient (MMR-D), and no specific molecular profile (NSMP). The goal is to improve treatment personalization by understanding how these molecular subtypes respond to therapies and to reduce over- or undertreatment while improving patient outcomes and quality of life. The trial compares chemotherapy alone versus chemoradiotherapy for women with p53 abnormal and nonendometrioid carcinoma subtypes. Chemotherapy involves paclitaxel and carboplatin every three weeks for six cycles, while chemoradiotherapy adds whole pelvic radiotherapy over 5 to 6 weeks after chemotherapy. For women with MMR-D and NSMP molecular subgroups, vaginal brachytherapy is compared to whole pelvic radiotherapy, with specific radiation doses and schedules defined for each treatment. Participants will be followed for at least five years to monitor for cancer recurrence, survival, adverse events, and patient-reported symptoms and quality of life. Assessments include tracking the location and timing of any cancer reappearance, overall survival, and recurrence-free survival. Women who consent to follow-up but not randomization will receive standard treatment and be monitored as part of the study. The entire study period involves long-term follow-up to evaluate outcomes and safety.

CONDITIONS

Brief Title

PErsonalized TReatment for Endometrial Carcinoma

Who Can Participate

Age: 18Years - 100Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 100 years
  • WHO performance status 0 to 2
  • Stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma
Not Eligible

You will not qualify if you...

  • Age under 18 years or over 100 years
  • WHO performance status greater than 2
  • Uterine sarcoma
  • History of malignancy within 5 years
  • Previous pelvic radiotherapy
  • More than 30 days between surgery and start of chemotherapy or more than 8 weeks between surgery and start of radiotherapy unless approved by investigator

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 3 to 4 months, depending on assigned treatment

Participants receive personalized treatment depending on their molecular subtype, including chemotherapy, chemoradiotherapy, vaginal brachytherapy, or whole pelvic radiotherapy.

6 chemotherapy cycles every 3 weeks or daily radiotherapy visits for 5 to 6 weeks

Follow-up

Duration - Up to 5 years

Participants are monitored for cancer recurrence, survival, adverse events, and quality of life for up to 5 years after treatment.

Regular follow-up visits over 5 years

Trial Site Locations

Total: 1 location

1

Helsinki University Hospital

Helsinki, Finland, 00290

Actively Recruiting

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Research Team

M

Mikko Loukovaara

R

Ralf Bรผtzow

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

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

Mikko Loukovaara, Ralf Bรผtzow, Synnรถve Staff...

https://pubmed.ncbi.nlm.nih.gov/37813479