Endometrial Cancer Lymphadenectomy Trial
Key facts
- Where
- Okayama és Saitama, JapánSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Forrás: NCT03438474: ki vehet részt
Where in Japán
- Okayama University HospitalOkayama, JapánTaking people
- Saitama Medical University International Medical CenterSaitama, JapánTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Philipps University Marburg
- Trial code
- NCT03438474
- Record updated
- 2024. november 25.
- Original description
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.Read full original descriptionShow less
Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence
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.
Inclusion: 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; age 18 - 75 years; written informed consent; adequate compliance.
Exclusion: preceding chemo-, radio, or endocrine therapy for EC; any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy; sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor); evidence of extrauterine disease by visual inspection; 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; stage pT1a, G1 or G2 tumors of type 1 histology; EC of FIGO stages III or IV (except for microscopical lymph node metastases); recurrent EC; any medical history indicating excessive peri-operative risk; 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).