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New treatment option for Cancer of Endometrium Stage I
Official title Endometrial Cancer Lymphadenectomy Trial
ClinicalTrials.gov ID: NCT03438474
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- histologically confirmed EC of clinical stages T1b and T2 (all histological types) and stage T1a G3 type 1 (endometrioid, endometriod with squamous...
- a) no previous surgery concerning EC (primary surgery) or b) surgery after hysterectomy (e.g. for presumed low risk endometrial cancer) is allowed...
- absence of bulky lymph nodes
- performance status ECOG 0-1
- age 18 - 75 years
You likely can't join if
- 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
- recurrent EC
- preceding chemo-, radio, or endocrine therapy for EC
See the full eligibility criteria
- 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...
- 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...
- absence of bulky lymph nodes
- performance status ECOG 0-1
- age 18 - 75 years
- written informed consent
- adequate compliance
- 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
- recurrent EC
- preceding chemo-, radio, or endocrine therapy for EC
- any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy
- any medical history indicating excessive peri-operative risk
- any current medication containing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents)
- any known disorder or circumstances making participation in trial and follow-up questionable. Insufficient compliance is expected.
- patients with second malignancies if disease or treatment might have an impact on the patient's prognosis
- known HIV-infection or AIDS
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Aalen, Germany
- Amberg, Germany
- Ansbach, Germany
- Augsburg, Germany
- Bad Homburg, Germany
- Bamberg, Germany
- Berlin, Germany
- Bonn, Germany
- Borna, Germany
- Böblingen, Germany
- Braunschweig, Germany
- Bremen, Germany
- Cologne, Germany
- Donauwörth, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Essen, Germany
- Frankfurt am Main, Germany
- Freiburg im Breisgau, Germany
- Fulda, Germany
+ 32 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalen, Germany; Amberg, Germany; Ansbach, Germany; Augsburg, Germany; Bad Homburg, Germany; Bamberg, Germany and 46 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.