No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
640 (estimated)
Sponsor
Philipps University Marburg · Other
Who this trial is looking for
This trial is looking for women with early-stage endometrial cancer who are at high risk of their cancer coming back. Participants will undergo surgery to remove the uterus and ovaries, and some may also have lymph nodes removed to see if it affects their chances of surviving cancer.
Are You a Good Fit for This Trial?
Rules you outHIV infectionAIDS
You may be able to join if
I have been diagnosed with endometrial cancer stages T1b or T2
I have no previous surgery for endometrial cancer
I do not have large lymph nodes
I am between 18 and 75 years old
I have given my written consent to participate
I am able to follow study instructions
You may not be able to join if
I have low-grade endometrial cancer (stage pT1a, G1 or G2)
I have any type of sarcoma besides carcinosarcoma
I have endometrial cancer stages III or IV
I have signs of cancer outside the uterus
I have had endometrial cancer before (recurrent)
I have received treatment for endometrial cancer before
I have a medical condition that prevents me from having surgery
I have a history that increases my surgical risk
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Eligibility Criteria
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 previo…
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)
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