endometrial cancer with preoperative rsik of lymph node metastasis (preoperative stage IB-IIIC1)
Conditions
Interventions
A: total abdominal hysterectmy+bilateral salpingo-oophorectomy+pelvic lymphadenectomy
B: total abdominal hysterectmy+bilateral salpingo-oophorectomy+pelvic lymphadenectomy+para-aortic lymphadenectomy
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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) 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 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| relapse-free survival, blood loss, operation time, bllod transfusion, surgery-related complications, adverse events ralated to chemotherapy, recurrence pattern (site) | — |
Countries
Japan
Contacts
Public ContactHidemichi Watari
JCOG1412 Coordinating Office Department of Gynecology, Hokkaido University Hospital
Outcome results
None listed