Personalized treatment options for endometrial cancer
PErsonalized TReatment for Endometrial Carcinoma
This study is testing different treatment options for women with early-stage endometrial cancer to see which ones work best based on their specific cancer type.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | University of Helsinki Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT05655260 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of different adjuvant therapies for women with stage I-II high-intermediate or high-risk endometrial carcinoma based on molecular classification. The study compares chemotherapy versus chemoradiotherapy for the p53 abnormal subtype and nonendometrioid carcinomas, as well as vaginal brachytherapy versus whole pelvic radiotherapy for the MMR-D and NSMP molecular subgroups. It is designed as a multicenter prospective trial, with a focus on improving treatment outcomes through personalized medicine. The primary outcome is the 5-year cumulative incidence of disease recurrence, while secondary outcomes include various recurrence rates and patient-reported symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 100 years with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma.
Not a fit: Patients with uterine sarcoma, a history of malignancy within the last 5 years, or those who have had previous pelvic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to more effective and tailored treatment options for women with endometrial carcinoma, potentially improving survival rates and quality of life.
How similar studies have performed: Other studies have shown promise in using molecular classification to guide treatment decisions in endometrial carcinoma, suggesting that this approach could be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Helsinki
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
Study contacts
- Principal investigator: Mikko Loukovaara — Helsinki University Central Hospital
- Study coordinator: Mikko Loukovaara
- Email: mikko.loukovaara@hus.fi
- Phone: +358504272526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.