Phase III Trial of Stage I Ovarian Cancer After Surgery
Epithelial Ovarian Cancer
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring epithelial ovarian cancer, FIGO stage I, staging surgery, adjuvant chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 active infection
- Patients with intestinal paralysis or intestinal obstruction
- Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy
- Patients with previous chemotherapy or radiation therapy
- Patients with serious drug hypersensitivity
- Patients with peripheral motor/sensory neuropathy [grade2,3,4 Common Terminology Criteria for Adverse Events (CTCAE) 4.0]
- 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.
- Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Sites / Locations
- Aichi Medical University HospitalRecruiting
- Tosei General HospitalRecruiting
- Fujita Health University HospitalRecruiting
- Hirosaki University School of Medicine & HospitalRecruiting
- The Jikei University School of Medicine Kashiwa HospitalRecruiting
- National Cancer Center Hospital EastRecruiting
- Ehime University HospitalRecruiting
- Kyusyu Medical CenterRecruiting
- Kyusyu Cancer CenterRecruiting
- Kyushu University HospitalRecruiting
- Kurume University HospitalRecruiting
- Gifu University HospitalRecruiting
- Gunma University HospitalRecruiting
- Gunma Prefectural Cancer CenterRecruiting
- JA Hiroshima General HospitalRecruiting
- Hiroshima City Hiroshima Citizens HospitalRecruiting
- Hiroshima Prefectural HospitalRecruiting
- Miyoshi Central HospitalRecruiting
- Hospital Hakodate HokkaidoRecruiting
- JA Sapporo-Kosei general HospitalRecruiting
- Hokkaido University HospitaRecruiting
- Hyogo Cancer CenterRecruiting
- Kansai Rosai HospitalRecruiting
- Japanese Red Cross Society Himeji HospitalRecruiting
- University of Tsukuba HospitalRecruiting
- Iwate Medical University HospitalRecruiting
- Kagoshima University Medical And Dental HospitalRecruiting
- Kagoshima City HospitalRecruiting
- Tokai University HospitalRecruiting
- St.Marianna University School of Medicine HospitalRecruiting
- Kitasato University HospitalRecruiting
- Yokohama Municipal Citizen's HospitalRecruiting
- Yokohama City University HospitalRecruiting
- Yokohama Minami Kyosai HospitalRecruiting
- Kanagawa Cancer CenterRecruiting
- Kobe City Medical Center General HospitalRecruiting
- Kumamoto University HospitalRecruiting
- Japanese Red Cross Kyoto Daiichi HospitalRecruiting
- Ise Red Cross HospitalRecruiting
- JA Matsuzaka Central HospitalRecruiting
- Mie University HospitalRecruiting
- Tohoku University HospitalRecruiting
- Shinshu University HospitalRecruiting
- Nagasaki University HospitalRecruiting
- Aichi Cancer CenterRecruiting
- Nara Prefecture General Medical CenterRecruiting
- Niigata University Medical and Dental HospitalRecruiting
- Niigata Cancer Center HospitalRecruiting
- Oita University HospitalRecruiting
- Hospital University of the RyukyusRecruiting
- Tomishiro Central HospitalRecruiting
- Okinawa Prefectural Chubu HospitalRecruiting
- Kaizuka City HospitalRecruiting
- Osaka International Cancer CenterRecruiting
- Osaka City University HospitalRecruiting
- Sakai City Medical CenterRecruiting
- Osaka University HospitalRecruiting
- Osaka Medical College HospitalRecruiting
- Kindai University HospitalRecruiting
- Saitama Medical University International Medical CenterRecruiting
- Saitama Cancer CenterRecruiting
- Koshigaya Municipal HospitalRecruiting
- Dokkyo Medical University Saitama Medical CenterRecruiting
- National Defense Medical College HospitalRecruiting
- Saitama National HospitalRecruiting
- Sapporo Medical University HospitalRecruiting
- Shikoku Cancer CenterRecruiting
- Shimane University HospitalRecruiting
- Shizuoka Cancer CenterRecruiting
- Japanese Red Cross Shizuoka HospitalRecruiting
- Dokkyo Medical University HospitalRecruiting
- Jichi Medical University HospitalRecruiting
- Tokushima University HospitalRecruiting
- Tokyo Women's Medical University Medical Center EastRecruiting
- Tokyo Medical And Dental University University Hospital of MedicineRecruiting
- Nippon Medical School HospitalRecruiting
- The University of Tokyo HospitalRecruiting
- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome HospitalRecruiting
- Sasaki Faundation Kyoundo HospitalRecruiting
- Tokyo Metropolitan Tama Medical CenterRecruiting
- The Jikei University Katsushika Medical CenterRecruiting
- The Jikei University Daisan HospitalRecruiting
- The Cancer Institute HospitalRecruiting
- Toho University Ohashi Medical CenterRecruiting
- The Jikei University HospitalRecruiting
- Keio University HospitalRecruiting
- Tokyo Women's Medical University HospitalRecruiting
- Kosei General HospitalRecruiting
- Tachikawa HospitalRecruiting
- Tottori Prefectural Central HospitalRecruiting
- Tottori University HospitalRecruiting
- Yamagata University HospitalRecruiting
- Tokuyama Central HospitalRecruiting
- Yamaguchi Red Cross HospitalRecruiting
- Nagano Municipal HospitalRecruiting
- Saiseikai Nagasaki HospitalRecruiting
- Saga University HospitalRecruiting
- Jichi Medical University Saitama Medical CenterRecruiting
- National Cancer CenterRecruiting
- Gachon University Gil Medical CenterRecruiting
- Seoul ST' Mary's HospitalRecruiting
- Kangbuk Samsung HospitalRecruiting
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Standard therapy
Observation
combination of paclitaxel and carboplatin
Observation