Pelvic and Para-aortic Lymphadenectomy in Patients with Stage I or II Endometrial Cancer with High Risk of Recurrence (ECLAT; AGO-OP.6) A Multicenter, Prospective Randomized Controlled Trial

Not Applicable

Recruiting

Conditions: Neoplasms

Registration Number: KCT0004981

Lead Sponsor: niversity Medical Center Gottingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 10

Inclusion Criteria

(1)histologically confirmed EC of clinical stages T1b and T2 (all histological types) and stage T1a G3 type 1 (endometrioid, endometriod with squamous differentiation, mucinous) or type 2 tumors (any percentage of serous or clear cell component) or carcinosarcoma
(2)no previous surgery concerning EC (primary surgery) or b) surgery after hysterectomy (e.g. for presumed low risk endometrial cancer) is allowed within 8 weeks after hysterectomy if no LNE was performed (secondary surgery)
(3)absence of bulky lymph nodes
(4)performance status ECOG 0-1
(5)age 18 - 75 years
(6)written informed consent
(7)adequate compliance

Exclusion Criteria

(1)stage pT1a, G1 or G2 tumors of type 1 histology
(2)sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor)
(3)EC of FIGO stages III or IV (except for microscopical lymph node metastases)
(4)evidence of extrauterine disease by visual inspection
(5)recurrent EC
(6)preceding chemo-, radio, or endocrine therapy for EC
(7)any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy
(8)any medical history indicating excessive peri-operative risk
(9)any current medication containing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents)
(10)any known disorder or circumstances making participation in trial and follow-up questionable. Insufficient compliance is expected.
(11)patients with second malignancies if disease or treatment might have an impact on the patient's prognosis
(12)known HIV-infection or AIDS
(13)simultaneous participation in other clinical trials if not permitted by the steering committee (translational or QoL studies not interfering with the objectives

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Disease free survival (DFS);Assessment of serious complications;Quality of life assessment (EORTC QLQ-C30);Quality of life assessment (EORTC QLQ-EN24);Number of resected lymph nodes