ovarian cancer
Conditions
Interventions
None listed
Sponsors
National Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.The applicant must have a histopathological diagnosis of ovarian cancer (including ovarian, fallopian tube, or peritoneal cancer). 2.Patients scheduled for interval debulking surgery (IDS) for primary and metastatic disease or who have undergone IDS (ctDNA can be drawn within 4 weeks (+-1 week) of IDS and only before chemotherapy after IDS). 3.Patients who have received less than 4 cycles of preoperative adjuvant chemotherapy. 4.Tumor tissue formalin-fixed paraffin-embedded specimens obtained by biopsy prior to the start of preoperative adjuvant chemotherapy must be available for submission to this study. 5.The patient must have stage 3 or stage 4 disease in the comprehensive findings. 6.A person who is able to take oral intake. 7.Persons who are 18 years of age or older at the time of obtaining consent. 8.Those with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 9.The applicant must be free from severe impairment of major organs (bone marrow, heart, lungs, liver, kidney, etc.) and meet the following criteria - Neutrophil count >=1,000/mm3 - Platelet count >= 75,000/mm3 - Hemoglobin >= 8.0 g/dL - Serum creatinine <=1.5 x upper limit of normal (ULN) - Total bilirubin <=1.5 x ULN - ALT and AST <=2.5 x ULN, or <=5 times ULN if liver metastases present. 10.Persons who have given their written consent to participate in the research of their own free will after a full explanation of the research has been given to them prior to enrollment in the study.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of treatment with PARP inhibitors or bevacizumab. 2.Patients who plan to use bevacizumab for preoperative adjuvant chemotherapy. 3.Persons with a history of malignancy(*6) (*6)Patients with a recurrence-free period of at least 5 years or with basal or spinous cell carcinoma of the skin, superficial bladder cancer, cervical cancer, carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma equivalent lesions that are considered cured by local treatment may be enrolled. 4.Persons with active local or systemic infections requiring treatment. 5.Persons who are HBs antigen positive, HBc antibody positive(*7) or HCV antibody positive(*8) (*7) HBc antibody positive, but HBV-DNA negative is acceptable for registration. (*8) HCV antibody-positive but HCV-RNA-negative patients are eligible for registration. 6.Must be HIV antibody positive (HIV antibodies may be untested for registration). 7.Patients with a history of interstitial lung disease requiring treatment (interstitial pneumonia, pulmonary fibrosis, etc.) or extensive findings of these diseases on CT. 8.Patients with uncontrolled complications(*8). (*8)Gastrointestinal bleeding, cardiac disease, glaucoma, diabetes, etc. 9.Patients receiving continuous systemic administration (oral or intravenous) of steroids (prednisolone equivalent of 10 mg/day or more for at least 2 weeks) 10.Persons who are judged to have difficulty enrolling in this study due to clinically problematic psychiatric disorders. 11.History of hemoptysis (sputum of 2.5 mL or more of fresh blood). 12.Pregnant or lactating women. 13.Other persons who are deemed by the physician in charge to be unsuitable for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival(OS), sensitivity and specificity of ctDNA for surgical completion, ctDNA positivity rate, ctDNA negativity rate, percentage of abnormal genes, and abnormal gene expression will be established and correlations of these outcomes with other clinicopathologic and molecular features and perioperative treatment will be analyzed in an exploratory manner. | — |
Countries
Japan
Contacts
Public ContactKenichi Harano
National Cancer Center Hospital East, Department of Medical Oncology
Outcome results
None listed