Cancer of Endometrium Stage I, Cancer of Endometrium Stage II
Conditions
Brief summary
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.
Interventions
PROCEDUREStandard surgical procedure for endometrial cancer
total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
PROCEDUREsystematic lymphadenectomy (LNE)
systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels
Sponsors
German Cancer Aid
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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. 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) 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 of ECLAT are allowed)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 60 months | Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease specific survival (DSS) | 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 months | Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease specific survival |
| Assessment of serious complications | during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months | Assessment of perioperative complications and site effects of LNE |
| Disease free survival (DFS) | 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 months | Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease free survival |
| EORTC QLQ-EN24 | 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 months | Health related Quality of life (QoL) |
| Number of resected lymph nodes | during surgery | resected pelvic and para-aortic lymph nodes |
| EORTC QLQ-C30 | 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 months | Health related Quality of life (QoL) |
Countries
Germany, Japan, South Korea
Contacts
Primary ContactPhilipp Harter, Professor MD
Backup ContactGünter Emons, Professor MD
Outcome results
None listed