Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059243) titled 'Prospective cohort study of Paclitaxel plus Carboplatin plus Bevacizumab Therapy as First Line Chemotherapy for Advanced Ovarian Clear cell Carcinoma' on Oct. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Chiba University Hospital
Condition:
Condition - Advanced ovarian clear cell carcinoma
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - We investigate the efficacy and safety of the combination chemotherapy of paclitaxal, carboplarin and bevacizumab in patients with advanced ovarian clear cell carcinoma (stage III/IV).
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
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.
Key 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.
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 30 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2030 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067688
Disclaimer: Curated by HT Syndication.
