The first-time recurrence/relapse of ovarian cell carcinoma.
Conditions
Interventions
1)Gemcitabine 1000mg/m2 intravenous drip day 1, 15 drip in 30 minutes. 2)Cisplatin 40mg/m2 intravenous drip day 1, 15 drip in 60 minutes. 3)Bevacizumab 10 mg/kg intravenous drip infusion day 1, 15 i
Sponsors
Kansai Clinical Oncology Group(KCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) A patient who has histopathologically diagnosed ovarian clear cell carcinoma (including mixed type) and relapsed at the first time after the initial treatment, or patients who relapsed during initial treatment. 2)The initial treatment is a combination of both surgery and chemotherapy or either. 3) The duration from the end of initial treatment to recurrence does not matter (both platinum-sensitive and platinum-resistant patients are eligible). 4) A patient has never been administered gemcitabine for the firstline chemotherapy. 5) A patient has the evaluable lesions. 6) Their age between 20 and 75 years. 7) Performance Status (ECOG) 0 to 2. 8) Laboratory test values within 2 weeks of enrollment satisfy all of the following items. 9) Patients expected to survive for 90 days or more from the start date of registration. 10) Written informed consent has been obtained.
Exclusion criteria
Exclusion criteria: 1)Patients with contraindications to Gemcitabine, Cisplatin or Bevacizumab 2)Patients with uncontrolled heart disease, renal disease, or diabetes 3) Patients with interstitial pneumonia or pulmonary fibrosis (confirmed by CT examination) 4)Patients with intestinal paralysis or intestinal obstruction 5) Patients with infectious diseases requiring treatment 6)Patients who have received radiotherapy to the chest or abdomen 7) Patients with active double cancer (not including carcinoma in situ) 8)Patients with a history of severe drug hypersensitivity 9) Patients with a history of underlying disease associated with obstructive bowel disease including subileus, patients with diverticulum, intestinal fistula, gastrointestinal perforation, intra-abdominal abscess, obvious rectosigmoid colon invasion by pelvic examination, CT examination Patients with clinical symptoms of obvious intestinal infiltration or intestinal obstruction due to 10)Patients with symptomatic central nervous system metastases 11)Patients who are pregnant or breastfeeding, or who may become pregnant during the treatment period of this protocol and are not willing to use contraception 12)Patients with the following diseases 13)Patients who are currently or recently (within 30 days prior to the start of this protocol treatment) receiving or receiving other investigational drugs (including unapproved drugs). 14)Patients who are judged inappropriate for participation in this study by investigators or subinvestigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS(Progression free survival), OS(Overall survival),DCR(disease control rate),AE(Adverse events),Relationship between pathological findings and response ARID1A,BRCA1/2,ATM,LOH scor,TP53,PIK3CA,MSI,TMB,HR related genes,if NGS was tested. | — |
Countries
Japan
Contacts
Public ContactKensuke Hori
Kansai Rosai Hospital Obstetrics and Gynecology
Outcome results
None listed