JPRN-jRCT1030210303
Recruiting
未知
Pelvic and Para-aortic Lymphadenectomy in Patients with Stage I or II Endometrial Cancer with High Risk of Recurrence. A Multicenter, Prospective Randomized Controlled Trial - ECLAT
Yabuno Akira0 sites15 target enrollmentSeptember 9, 2021
Conditionsendometrial cancer
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- endometrial cancer
- Sponsor
- Yabuno Akira
- Enrollment
- 15
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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) orcarcinosarcoma
- •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 type1 histology
- •2\. sarcomas (except for carcinosarcoma \= malignant mixed Mullerian tumor)
- •3\. EC of FIGO stages IIIor 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
- •10\. any known disorder or circumstances making participation in trial and follow\-up questionable. Insufficient compliance is expected.
Outcomes
Primary Outcomes
Not specified
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