Endometrial Cancer Lymphadenectomy Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorPhilipps University Marburg
About this trial
The primary aim of this trial is to ascertain whether or not systematic pelvic and para-aortic lymphadenectomy (LNE) does have a significant impact on overall survival (OS) in patients with endometrial cancer (EC) FIGO Stages I or II and high risk of recurrence. Secondary aims will be to evaluate the effect of LNE on disease free survival (DFS) and quality of life, as well as the complications and side effects of LNE and the number of resected lymphnodes. 640 patients with histologically confirmed EC with high risk of recurrence (stage pT1b - pT2, all histological subtypes; pT1a, G3 endometrioid or serous or clear cell EC or carcinosarcomas) will be randomized. In Arm A, a total hysterectomy and bilateral salpingo-oophorectomy and in case of serous or clear cell EC additionally an omentectomy will be performed. In arm B in addition a systematic pelvic and para-aortic LNE up to the level of the left renal vein will be performed.
Eligibility criteria
Qualifiers
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
a) 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)
absence of bulky lymph nodes
performance status ECOG 0-1
Disqualifiers
stage pT1a, G1 or G2 tumors of type 1 histology
sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor)
EC of FIGO stages III or IV (except for microscopical lymph node metastases)
evidence of extrauterine disease by visual inspection
Trial design
Treatments tested in this trial
- Standard surgical procedure for endometrial cancer
- systematic lymphadenectomy (LNE)
Treatment groups
640 Participants
are divided into 2 treatment groupsSponsors and collaborators
Philipps University Marburg
Lead sponsor
German Cancer Aid
Collaborator
Source ClinicalTrials.gov