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Clinical Trials/JPRN-jRCT1030210303
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

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.

Registry
who.int
Start Date
September 9, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Yabuno Akira

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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