PErsonalized TReatment for Endometrial Carcinoma
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Age 18 to 100 years
• WHO performance status 0 to 2
• Stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma
Locations
Other Locations
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Contact Information
Primary
Mikko Loukovaara
mikko.loukovaara@hus.fi
+358504272526
Backup
Ralf Bützow
ralf.butzow@hus.fi
+358504271899
Time Frame
Start Date: 2022-02-08
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 300
Treatments
Experimental: p53 abn subtype and nonendometrioid carcinomas
p53 abn stage I-II MI (myometrial invasion) \>0%; MMR-D/NSMP nonendometrioid stage I-II MI \>0%
Experimental: MMR-D molecular subgroup
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;
Experimental: NSMP molecular subgroup
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;
Related Therapeutic Areas
Sponsors
Collaborators: Kymenlaakso Central Hospital Kotka Finland, Oulu University Hospital, Tampere University Hospital, South Carelia Central Hospital, Päijänne Tavastia Central Hospital, Turku University Hospital, Kuopio University Hospital
Leads: University of Helsinki