Phase III Trial of Stage I Ovarian Cancer After Surgery

Prior treatment

• Patients with previous chemotherapy or radiation therapy

Other illness

• Patients with active infection
• Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy
• Patients with serious drug hypersensitivity
• Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
• Patients with positive HBsAg. Patients with more than 2.1 log/copies ml based on fixed Hepatitis B virus (HBV)-DNA who are positive with either antigen-positive Hepatitis B (HBs), anti-hepatitis B core antigen or anti-hepatitis B surface antigen.

Other

• FIGO Stages Ic(a), Ic(1) and Ic(2)
• Patients containing sarcoma elements
• Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT
• Patients with serious complications
• Patients with intestinal paralysis or intestinal obstruction
• Patients with peripheral motor/sensory neuropathy \[grade2,3,4 Common Terminology Criteria for Adverse Events (CTCAE) 4.0\]
• Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician

• Patients with a diagnosis of histopathologically epithelial ovarian cancer
• FIGO Stages Ia(Grade2/3, clear cell carcinoma), Ib(Grade2/3, clear cell carcinoma) and Ic(b)(all degree of differentiation and all histologic type)
• Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy.
• Patients who received comprehensive staging surgery (basic surgical techniques (total hysterectomy, bilateral salpingo-oophorectomy, and omentectomy) as well as peritoneal cytology, multiple biopsies of the peritoneum (\[Peritoneal biopsy\] see details below), retroperitoneal lymph node dissection (see details below \[Retroperitoneal lymph node dissection\]).
  • However, for the following cases, it is eligible as a condition to record on the official document.
  • Peritoneal biopsy: peritoneal metastasis is not recognized by macroscopic and palpation in the stipulated site, and the case that biopsy has not been performed.
  • Retroperitoneal lymph node dissection: the case that lymph nodes of the stipulated range has been dissected however the prescribed number has not been reached.
• Age: 20 or older
• Performance status (PS):0-1
• Case with initial therapy for postoperative primary lesion
• Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery
• Reasonable organ function
• Patient must have signed informed consent.