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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Standard surgical procedure for endometrial cancer
Procedure/Surgerytotal hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
systematic lymphadenectomy (LNE)
Procedure/Surgerysystematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels
Treatment groups
640 Participants
are divided into 2 treatment groupsGroup A: Arm A standard surgical procedureActive comparator 1 intervention
Group B: Arm B systematic lymphadenectomy (LNE)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Overall survival (OS)
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence
Time frame
60 monthsSecondary outcomes
1
Disease free survival (DFS)
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease free survival
Time frame
3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months2
Disease specific survival (DSS)
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease specific survival
Time frame
3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months3
Assessment of serious complications
Assessment of perioperative complications and site effects of LNE
Time frame
during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months4
EORTC QLQ-C30
Health related Quality of life (QoL)
Time frame
Baseline, at hospital discharge, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Philipps University Marburg
Lead sponsor
German Cancer Aid
Collaborator
Source ClinicalTrials.gov