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
- Conditions
- C54Malignant neoplasm of corpus uteri
- Registration Number
- DRKS00016541
- Lead Sponsor
- niversitätsklinikum Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 500
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
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free Survival
- Secondary Outcome Measures
Name Time Method Overall Survival<br>QOL (EORTC QLQ-C30, SAQ, German Pelvic Floor Questionnaie, Lymphedema-Questionnaire).