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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 78
- 主要终点
- chemotherapy response score(CRS) 3
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Pathological slides of omentum will be independently reviewed by two pathologists who will be blinded to the randomization to determine the CRS.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
dd-nabTC
albumin-bound paclitaxel (100 mg/m2, days 1, 8, and 15, every 4 weeks) combined with carboplatin (AUC = 5, day 1, every 4 weeks)
干预措施: albumin-bound paclitaxel (Drug)
CONTROL
paclitaxel (175 mg/m2, day 1, every 4 weeks) combined with carboplatin (AUC=6, day1, every 4 weeks)
干预措施: paclitaxel (Drug)
结局指标
主要结局
chemotherapy response score(CRS) 3
时间窗: At the end of cycle 3 NACT (each cycle is 21 days)
the proportion of chemotherapy response score 3
次要结局
- PFS(From date of randomization until the date of first documented progression, assessed up to 3 years)
- OS(From date of randomization until the time of death from any cause, assessed up to 3 years)
- AEs(during the treatment procedure)