Endometrial Cancer Lymphadenectomy Trial

JRCT ID: jRCT1030210303

Registered date:09/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: endometrial cancer
• Date of first enrollment: 09/09/2021
• Target sample size: 15
• Countries of recruitment: Germany,Japan,Korea,Japan
• Study type: Interventional

Intervention(s)

Arm A:
Standard surgical procedure for endometrial cancer:
total hysterectomy, bilateral salpingo-oophorectomy, omentectomy
(type 2 cancers)
Arm B:
In addition to standard procedures as defined for Arm A:
systematic pelvic and para-aortic lymphadenectomy (LNE) up to the
renal vessels

Outcome(s)

• Primary Outcome: Overall survival (OS)

Secondary Outcome

-Disease free survival (DFS)
-Disease specific survival (DSS)
-Assessment of perioperative complications and site effects of LNE
-Health related Quality of life (QoL)(EORTC QLQ-C30, EORTC QLQ-EN24)
-Number of resected lymph nodes

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Female

Include 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

Exclude 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.
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)

Related Information

• Primary Sponsor: Yabuno Akira
• Secondary ID(s): NCT03438474