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/37813479Actively Recruiting
Led by University of Helsinki ยท Updated on 2024-12-06
300
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of Helsinki
Lead Sponsor
T
Turku University Hospital
Collaborating Sponsor
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
PErsonalized TReatment for Endometrial Carcinoma
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Helsinki University Hospital
Helsinki, Finland, 00290
Actively Recruiting
M
Mikko Loukovaara
R
Ralf Bรผtzow
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Mikko Loukovaara, Ralf Bรผtzow, Synnรถve Staff...
https://pubmed.ncbi.nlm.nih.gov/37813479