patients with poor prognostic OVARian cancers based on the unfavorable tumor primary chemosensitivit ovarian cancer
Conditions
Interventions
1)Standard arm: Continuation of the same 3-weekly carboplatin-paclitaxel, as administered during the neo-adjuvant chemotherapy +/- combined with peg-GCSF or GCSF daily sub-cutaneous administrations, a
dose-dense regimen
Sponsors
Okamoto Aikou
Benoit YOU
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed high-grade epithelial (serous, endometrioid, or carcinosarcoma with more than 30% of epithelial tumor component) ovarian, primary peritoneal, or fallopian-tube carcinoma 2.Adult patients 18 years and older 3.Advanced stage 3 or 4 disease 4.Treated with 3 to 4 neo-adjuvant cycles of standard 3-weekly carboplatin-paclitaxel regimen in first-line setting, and characterized by KELIMTM score calculated by KELIM academic tool is less than 1.0 Not amenable to complete interval debulking surgery (incomplete interval debulking surgery attempt, or disease not operated at all because considered not amenable to complete surgery by surgeon) 5.ECOG performance status 0 or 1 6.Adequate organ and bone marrow function for weekly-dense chemotherapy 7.Adequate renal and liver functions 8.Patients who gave its written informed consent to participate to the study 9.Patients affiliated to a social insurance regime 10.Patients willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Exclusion criteria
Exclusion criteria: 1.Patients with low-grade endometrial, clear cell, myxoid, or sarcoma histology, mixed types including any of these, or low-grade or borderline ovarian tumors Patients with contraindications to the agents being evaluated in this study (carboplatin, paclitaxel, granulocyte colony-stimulating factor (G-CSF)) 2.Patients receiving bevacizumab during initial standard of care (NAC) 3.Patients refractory to primary platinum regimens (defined as progression during NAC) 4.Patients with other concomitant cancers (except: appropriately treated non-melanoma skin cancer, curatively treated cervical intraepithelial carcinoma, or other solid tumors that have not recurred for at least 5 years) 5.Patients receiving treatment with investigational agents from other clinical trials. 6.Patients with unstable conditions that, in the judgment of the physician, may interfere with patient safety or participation and significantly affect study results, including but not limited to the following Unstable angina pectoris Myocardial infarction within 6 months of first dose Uncontrolled and/or severe complications Active infection requiring intravenous therapy (bacterial or viral) within 2 weeks of the first dose Gastric pyloric obstruction Small bowel obstruction (SBO) is defined by computed tomography (CT) scan as: small bowel dilatation within 12 weeks of study entry, symptomatic ascites/exudate requiring puncture or thoracentesis within 30 days of study entry. 7. Patients with known mental disorders that may interfere with study compliance 8. Pregnant or lactating patients or patients expected to become pregnant during the study period 9. Patients whose liberty is restricted, wards or conservators of the adult guardianship system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients operated with late complete debulking surgery after 3 cycles of treatment Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate according to RECIST ver.1.1 in the whole population Progression-free survival in the whole population Percentage of patients who underwent late complete debulking surgery regardless of number of cycles Percentage of patients treated with a subsequent maintenance treatment with a PARP inhibitor in the whole population Progression-free survival and overall survival in these patients compared to those not treated with PARP inhibitor In the population of patients treated with bevacizumab Overall response rate according to RECIST Ver.1.1 Progression-free survival and overall survival according to RECIST Ver.1.1 Percentage of patients operated with a late complete debulking surgery Adverse events graded according to the NCI Common Terminology Criteria Adverse Event Version 5.0 | — |
Countries
Czech Republic, France, Hungary, Israel, Italy, Japan, Netherlands, Slovakia, Slovenia, United Kingdom
Contacts
Public ContactNozomu Yanaihara
The Jikei University Hospital
Outcome results
None listed