Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer:A Multicentre, Single-arm, Phase II Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- ORR (objective response rate)
研究概览
简要总结
Based on the Phase I trial completed by the sponsor, the Phase II clinical trial aims to investigate the effectiveness and safety of image guidance volume-modulated arc radiation therapy concurrently with Nab-Paclitaxel plus Cisplatin for patients with locally advanced cervical cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •(1) Stage IB3 to IVA disease based on the 2018 International Federation of Gynecology and Obstetrics (FIGO) system;
- •(2) Eastern Cooperative Oncology Group at 2 or less;
- •(3) Life expectancy of greater than 3 months;
- •(4) Left ventricular ejection fraction at ≥55%;
- •(5) Neutrophil count at ≥1500/mm^3, platelet count at ≥100,000/mm^3 or hemoglobin at ≥9.0 g/dL;
- •(6) Serum creatinine at <1.5 times the upper limit of the normal reference range;
- •(7) Alanine transaminase or aspartate aminotransferase at >2.5 times the upper limit of the normal reference range;
- •(8) Non pregnant or lactating women;
- •(9) Women of childbearing age willing to adopt reliable contraceptive measures;
- •(10) Sign informed consent form.
排除标准
- •(1) Individuals who have previously received chemotherapy with albumin bound paclitaxel;
- •(2) Individuals who have previously received abdominal or pelvic radiation therapy;
- •(3) Individuals who have received neoadjuvant chemotherapy or targeted, immunotherapy, and other anti-tumor treatments prior to concurrent chemoradiotherapy and chemotherapy;
- •(4) Individuals with central nervous system diseases or brain metastases；
- •(5) Other malignant tumors other than cervical cancer have appeared within the past 5 years;
- •(6) Previously experienced sensory or motor neuropathy (Grade ≥ 2) ;
- •(7) The researchers evaluate that the uncontrolled serious medical diseases that will affect the ability of the participants to receive the treatment of the clinical trial, such as complicated with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc;
- •(8) known to be allergic to paclitaxel;
- •(9) Received other experimental drugs or participated in clinical studies for other anti-cancer treatment purposes within 30 days of the first chemotherapy administration;
- •(10) Serious infections occurring within 4 weeks prior to the start of research treatment, including but not limited to complications of infection requiring hospitalization, bacteremia, or severe pneumonia;
- •(11) Human immunodeficiency virus (HIV) positive individuals;
- •(12) Uncontrolled or active viral hepatitis or infection with human immunodeficiency virus;
- •(13) Researchers determine that it is not suitable to participate in this study.
研究组 & 干预措施
Experimental group
Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week).
干预措施: radiotherapy (Radiation)
Experimental group
Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week).
干预措施: Nab paclitaxel (Drug)
Experimental group
Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week).
干预措施: Cisplatin (Drug)
结局指标
主要结局
ORR (objective response rate)
时间窗: the 1, 3, 6, 9, 12 months after the end of the treatment
ORR(objective response rate)=CR (complete response)+PR(partial response)/all participants
次要结局
- OS(the 1, 2, and 3 years after the end of the treatment)
- DOR(the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment)
- AE(the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment)
- DCR(the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment)
- CBR(the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment)
- PFS(the 1, 2, and 3 years after the end of the treatment)