Effect of Albumin-bound Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Patients Receiving Neoadjuvant Chemotherapy for Advanced Ovarian, Fallopian Tube or Peritoneal Cancer: A Phase 2 Single Center Clinical Trial
- Conditions
- Ovarian Cancer
- Interventions
- Registration Number
- NCT05316376
- Brief Summary
Neoadjuvant chemotherapy (NACT) is an important option for patients with advanced ovarian cancer. Paclitaxel plus carboplatin is the first-line regimen for ovarian cancer NACT patients. However, the efficacy of NACT is controversial, how to improve the efficacy become an urgent problem to be solved in the treatment of ovarian cancer. It has been confirmed that the dose-intensive paclitaxel combined carboplatin regimen can improve the prognosis in Asian patients with advanced ovarian cancer. However, this protocol has a low rate of complete tumor remission after NACT (4%) with toxicities and high probability of severe hypersensitivity reactions. Albumin-bound paclitaxel has the characteristics of tumor targeting, low allergenicity. We propose that dose-dense albumin-bound paclitaxel (ddnab-paclitaxel) (100 mg/m2, days 1, 8, and 15) combined with carboplatin (AUC = 5 days 1, 4 weeks) regimen may be superior to the paclitaxel plus carboplatin regimen. We conducted this Phase II randomized controlled study to testify the efficacy of dd-nab paclitaxel. 57 stage IIIC-IV patients with high-grade epithelial, fallopian tube, and peritoneal cancer who are unable to undergo optimal cytoreduction and receive NACT after tumor biopsy will be recruited. The regimen for the study group is albumin-bound paclitaxel (100 mg/m2, days 1, 8, and 15 doses) combined with carboplatin (AUC = 5 day 1, 4 weeks), while patients in the control group use paclitaxel (175 mg/m2, day 1) combined with carboplatin (AUC=6, day1). Interval debulking surgery(IDS) will be performed within 3-4 weeks after 3 cycles of NACT. The primary endpoint is the proportion of Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints are progression-free survival(PFS), overall survival(OS) and the rates of complete resection and adverse events(AEs).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 78
- International Federation of Gynecology and Obstetrics(FIGO) stage IIIC-IVA, HGSOC Patients with Fagotti score ≥8
- Adequate kidney function (blood creatinine 58-96 µmol/L)
- Adequate haematological function (haemoglobin ≥110g/L, leucocytes ≥4.0×109/L, neutrophils ≥2.0×109/L, platelets≥100×109/L)
- Adequate liver function (serum total bilirubin 3.4-22.2µmol/L, alanine aminotransferase (ALT) 7-40U/L, aspartate aminotransferase (AST) 13-35U/L, AST/ALT ≤1.5)
- World Health Organization(WHO) score 0-2
- expected lifespan>12 weeks
- Patients who had received chemotherapy, radiotherapy or any kind of targeted therapy
- Complicated with any other known malignancies
- Patients with poor cardiopulmonary function, which would limit compliance with study requirements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CONTROL paclitaxel paclitaxel (175 mg/m2, day 1, every 4 weeks) combined with carboplatin (AUC=6, day1, every 4 weeks) dd-nabTC albumin-bound paclitaxel albumin-bound paclitaxel (100 mg/m2, days 1, 8, and 15, every 4 weeks) combined with carboplatin (AUC = 5, day 1, every 4 weeks)
- Primary Outcome Measures
Name Time Method chemotherapy response score(CRS) 3 At the end of cycle 3 NACT (each cycle is 21 days) the proportion of chemotherapy response score 3
- Secondary Outcome Measures
Name Time Method PFS From date of randomization until the date of first documented progression, assessed up to 3 years progression-free survival
OS From date of randomization until the time of death from any cause, assessed up to 3 years overall survival
AEs during the treatment procedure adverse effects of chemotherapy