FIGO stage III-IV epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer
Conditions
Interventions
1. Neoadjuvant chemptherapy (NAC): 3 cycles of dose-dense paclitaxel and carboplatin therapy plus bevacizumab 2. Interval debulking surgery (IDS) 3. Postoperative chemotherapy: 3 cycles of dose-dens
Sponsors
Department of obstetrics and gynecology, Keio University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patient diagnosed with FIGO stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer by exploratory laparotomy or by clinical findings including cytology/biopsy, imaging studies, and tumor marker (CA125 >200U/mL and CEA <20ng/mL are eligible for the study) 2. ECOG Performance Status: 0-2 3. Adequate organ function (within 28 days prior to registration): absolute neutrophil count >=1.5 G/L, platelet count >=100 G/L, AST/ALT <=100 IU/L, total bilirubin <= 1.5 mg/dl, serum creatinine <= 1.5 mg/dl, proteinuria <= 1+, no abnormal finding to need treatment on 12-lead ECG, neuropathy (sensory and motor) grade <= 1 4. Patient expected to survive longer than 3 months 5. Age: 20 or older at registration 6. Patient must have signed informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who have received previous chemotherapy or radiation therapy to treat the current disease 2. Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are eligible for the study) 3. Patients with serious medical complications, such as serious heart disease, cerebrovascular accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis, interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious neurological disorder 4. Patient with active infection at registration 5. Patient suspected or diagnosed as arterial or venous thromboembolism at registration 6. Patients with gastrointestinal perforation, abdominal fistula, intra-abdominal abscess, tumor invading deeply to intestinal tract, intra-abdominal inflammation, or intestinal obstruction 7.Patient with a history of hemoptysis (hemoptysis of fresh blood of 2.5ml or more) 8. Patient with a history of abdominal radiation therapy 9. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil, or alchohol 10. Pregnancy or during breast feeding or a patient willing to be pregnant 11.Patient who is judged inappropriate to participate in this study by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| surgical completion rate | — |
Secondary
| Measure | Time frame |
|---|---|
| treatment completion rate, tolerability, adverse event, response rate, pathological remission rate, surgical invasiveness, progression free survival, overall survival | — |
Countries
Japan
Contacts
Public ContactHiroyuki Nomura
Keio University School of Medicine Department of obstetrics and gynecology
Outcome results
None listed