JCOG1412: Randomized phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy for patients with endometrial cancer

JRCT ID: jRCTs031180269

Registered date:13/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: endometrial cancer with preoperative risk of lymph node metastasis (preoperative stage IB-IIIC1)
• Date of first enrollment: 24/01/2017
• Target sample size: 590
• Study type: Interventional

Intervention(s)

Arm A:
total abdominal hysterectomy+bilateral salpingo-oophorectomy
+pelvic lymphadenectomy

Arm B:
total abdominal hysterectomy+bilateral salpingo-oophorectomy
+pelvic lymphadenectomy+para-aortic lymphadenectomy

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: relapse-free survival, blood loss, operation time, blood transfusion, surgery-related complications, adverse events ralated to chemotherapy, recurrence pattern (site)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Female

Include criteria

1st inclusion criteria (before surgery)
1. Histologically diagnosed endometrial carcinoma (endometrioid, mucinous, serous, clear cell, undifferentiated, mixed)
2. Preoperative IB, II, IIIA, IIIB, IIIC
Patients with preoperative stage IIIC must fulfill both i) diagnosed by enhanced CT or PET/CT and ii) diagnosed by enhanced CT
i) No para-aortic lymph node (PAN) swelling and no multiple pelvic lymph node (PLN) swelling ii) PAN swelling or multiple PLN swelling with negative PET
Lymph node swelling is defined as a node with 10mm or more of minor axis
3. No peritoneal dissemination, no distant metastasis, and no inguinal node metastasis by enhanced CT or PET/CT
4. No bladder invasion, no rectum invasion by enhanced MRI
5. 20-75 years old
6. ECOG performance status of 0 or 1
7. Body mass index<=35
8. No prior surgery for gastrointestinal tract (appendectomy is allowed)
9. No prior treatment with irradiation or chemotherapy for any malignancies
(exclude history of breast cancer with 5-year disease-free)
10. Adequate organ functions
i. WBC>= 3,000/mm3
ii. Platelet >= 100,000/mm3
iii. T.Bil <= 1.5 mg/dL
iv. AST <= 100 IU/L
v. ALT <= 100 IU/L
vi. Creatinine <= 1.5 mg/dL
11. Written informed consent
2nd inclusion criteria (during surgery)
1. Not suspicious for para-aortic node metastasis by inspection and palpation.
In case of suspicious para-aortic node metastasis, negative result by frozen section diagnosis
2. Not suspicious for node metastases of multiple pelvic regions by inspection and palpation.
In case of suspicious node metastases of multiple pelvic regions, all nodes are negative or only one region of pelvic node metastasis is allowed by frozen section diagnosis.
3. Not suspicious for peritoneal dissemination by inspection and palpation
In case of suspicious peritoneal dissemination, negative result by frozen section diagnosis
4. Neither suspicious for bladder invasion nor rectum invasion

Exclude criteria

1. Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor
2. Active systemic infections to be treated
3. Body temperature of 38 degrees Celsius or higher
4. Women during pregnancy, possible pregnancy, postpartum within 28 days or breast-feeding
5. Psychiatric disease
6. Currently treated with continuous systemic steroid, immunosuppressive agents
7. Uncontrolled diabetes mellitus or routine administration of insulin
8. Currently treated with continuous anticoagulant drug/antiplatelet agent
9. Uncontrolled hypertension
10. History of cardiac failure, unstable angina or prior myocardial infarction within 6 months
11. HBs antigen positive
12. HIV antibody positive
13. Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema
14. Hypersensitivity to polyoxyethylated castor oil or hydrogenated castor oil
15. Hypersensitivity to alcohol

Related Information

• Primary Sponsor: WATARI Hidemichi
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000025399