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Prospective, European collaborative multicenter observational study of standardized, ontogenetically based radical surgery in endometrial cancer FIGO IAG3 and stage IB to III by peritoneal mesometrial resection and therapeutic lymphadenectomy (PMMR/tLNE) without additional radiotherapy

Prospective, European collaborative multicenter observational study of standardized, ontogenetically based radical surgery in endometrial cancer FIGO IAG3 and stage IB to III by peritoneal mesometrial resection and therapeutic lymphadenectomy (PMMR/tLNE) without additional radiotherapy - PMMR-Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00016541
Enrollment
500
Registered
2019-07-01
Start date
2018-03-22
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C54

Interventions

Group 1: Therapy of endometrial cancer according to current guidelines follow-up visits 6, 12 and 24 months after surgery as well as annual follow up from 24 months on Group 2: Therapy of endometrial

Sponsors

Universitätsklinikum Essen
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Histologically proven endometrial carcinoma: endometroid and non-endometroid FIGO stages I-III; Karnofsky-Index = 70; unrestricted operability; Age >=18 years. - Completed treatment with according Cohort A, PMMR/targeted compartmental pelvic/paraaortic +/- complete pelvic and paraaortic LNE without adjuvant radiotherapy by the responsible clinic (clinician). or - Completed treatment according Cohort B, current clinical practice including adjuvant treatment based on ESMO/ESGO/ESTRO guidelines [26] by the responsible clinic (clinician). - Informed consent of the patient

Exclusion criteria

Exclusion criteria: Uterine pure sarcoma - Distant metastases; sclerodermia, lupus erythematodes, mixed connective tissue disease; secondary malignancy; previous radiotherapy of the pelvis. - Pregnancy - Patients with diseases of the connective tissue will be excluded because of unforeseeable (e.g. neurological) symptoms and disorders after surgery. - Postoperative radiotherapy could be administered with respect to the surgical field in R1 situation or if >= 5 lymph nodes were involved; in all other situations adjuvant radiotherapy will be an exclusion criterion for participation in the study cohort A.

Design outcomes

Primary

MeasureTime frame
Progression-free Survival

Secondary

MeasureTime frame
Overall Survival QOL (EORTC QLQ-C30, SAQ, German Pelvic Floor Questionnaie, Lymphedema-Questionnaire).

Countries

Germany, Sweden

Contacts

Public ContactKatharina Denzel

Universitätsfrauenklinik Essen Studiensekretariat

katharina.denzel@uk-essen.de+4920172385647

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026