Advanced ovarian clear cell carcinoma
Conditions
Interventions
None listed
Sponsors
Chiba University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed, histologically confirmed ovarian clear cell carcinoma, FIGO stage III - IV. All patients underwent appropriate surgical procedures, including diagnostic laparoscopy, to obtain tissue for histopathological confirmation of ovarian clear cell carcinoma. In cases with mixed histology, clear cell carcinoma accounted for the predominant component (>50%). A central pathological review was not performed. Immunohistochemical evaluation for WT1 (negative), p53 (negative), and Napsin A (positive) was performed for confirmation, although it was not required. 2. Patients scheduled to receive combination chemotherapy with paclitaxel and carboplatin plus bevacizumab, who have provided informed consent for treatment. In cases where bevacizumab is contraindicated, up to two cycles of paclitaxel - carboplatin chemotherapy without bevacizumab are permitted. Patients who do not receive bevacizumab within three cycles will be excluded from the primary analysis of this study. 3. Patients aged 18 years or older. 4. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Patients with adequate organ function. 6. Patients who have provided written informed consent to participate in this clinical trial. 7. Patients who are able to initiate chemotherapy within 6 weeks after primary surgery.
Exclusion criteria
Exclusion criteria: 1. Patients with contraindications specific to bevacizumab, including active pulmonary hemorrhage, cerebral hemorrhage, congenital bleeding diathesis, coagulation disorders, a history of cerebral infarction, active deep vein thrombosis (DVT), pulmonary embolism (PE), uncontrolled hypertension (>= grade 3), or proteinuria (>= grade 3, urine protein-to-creatinine ratio [UPC] >= 3.5). Active DVT or PE is defined as symptomatic thrombosis or non-organized thrombosis under anticoagulation therapy (i.e., cases not controlled with anticoagulation). 2. Patients who are scheduled to receive PARP inhibitors alone as maintenance therapy following first-line chemotherapy. 3. Patients with a history of obstructive bowel disease, including subileus, or underlying conditions such as diverticulitis, enteric fistula, gastrointestinal perforation, or intra-abdominal abscess; patients with evident rectosigmoid invasion on pelvic examination; or patients with radiologically confirmed bowel invasion or clinical symptoms of bowel obstruction on CT imaging. Patients in whom the invasive lesion involving the rectosigmoid or other bowel sites has been surgically resected are eligible. 4. Patients with a history of hypersensitivity to any agents used in combination with bevacizumab. 5. Patients with a history of abdominal radiotherapy. 6. Patients with a history of hemoptysis (>= 2.5 mL of fresh blood). 7. Patients with severe infections at the time of enrollment. 8. Patients deemed by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survaival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, survival rate, response rate, adverse effects | — |
Countries
Japan
Contacts
Public ContactS Tate
Japanese Gynecologic Oncology Group Japanese Gynecologic Oncology Group
Outcome results
None listed