Concurrent Chemoradiotherapy Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer, a Prospective, Single Arm Study
试验速览
- 阶段
- 2 期
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- progression-free survival (PFS) rate at 1 year
研究概览
简要总结
This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. The primary endpoint was progression-free survival (PFS) rate at 1 year. The secondary endpoints were PFS, overall survival (OS) and safety.
详细描述
This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. Endostar (30 mg/d) was administered on days 1-5 every two weeks for 4 cycles. Cisplatin (30-40 mg/m2) was administered day 1, 8, 15, 22 and 29. The primary endpoint was progression-free survival (PFS) rate at 1 year. The secondary endpoints were PFS, overall survival (OS) and safety.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years old;
- •Histologically confirmed to be cervical squamous cell carcinoma;
- •Clinical stage IIB (need to have lymph node metastasis), IIIA, IIIB, IVA (2018 version of FIGO stage);
- •The ECOG PS score is 0 or 1;
- •At least one measurable (measured according to RECIST 1.1);
- •No distant organ metastasis confirmed by abdominal CT, chest CT, bone ECT, etc;
- •This treatment must be the first course of treatment;
- •The expected survival expectation is not less than 6 months;
- •The main organ function meets the following criteria within 7 days before treatment:
- •Blood routine examination standard (without blood transfusion within 14 days):
- •hemoglobin (HB) ≥ 90g / L;
- •neutrophil absolute value (ANC) ≥ 1.5 × 10 9 / L;
- •platelets (PLT) ≥ 80 × 10 9 / L.
- •Biochemical tests are subject to the following criteria:
- •total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- •alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 times ULN;
- •serum creatinine (Cr) ≤ 1.5 times ULN or creatinine clearance (CCr) ≥ 60ml / min;
- •Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
- •(10) Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days prior to study enrollment And must be non-lactating patients; (11) Can understand the study and have signed an informed consent form;
排除标准
- •Patients with distant metastases;
- •Those suffering from other malignant tumors;
- •Have received cancer-related treatment such as radiotherapy or chemotherapy before enrollment;
- •Patients with contraindications to radiotherapy and chemotherapy, including serious infections or other complications such as severe cerebrovascular disease, mental illness and uncontrollable diabetes;
- •During pregnancy or lactation;
- •Those who have received targeted therapy;
- •Those who are in other drug trials;
- •Those with serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension;
- •It is known that there is a hypersensitivity reaction to any component contained in the Endostar formulation;
研究组 & 干预措施
Chemoradiotherapy
Radiation:
Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.
Drug: Endostar 30 mg/d was administered on days 1-5 every two weeks for 4 cycles.
Drug: Cisplatin 30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.
干预措施: Radiotherapy (Radiation)
Chemoradiotherapy
Radiation:
Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.
Drug: Endostar 30 mg/d was administered on days 1-5 every two weeks for 4 cycles.
Drug: Cisplatin 30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.
干预措施: Endostar (Drug)
Chemoradiotherapy
Radiation:
Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.
Drug: Endostar 30 mg/d was administered on days 1-5 every two weeks for 4 cycles.
Drug: Cisplatin 30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.
干预措施: Cisplatin (Drug)
结局指标
主要结局
progression-free survival (PFS) rate at 1 year
时间窗: 1 year
The rates of patients who were progression free at 1-year after enrollment
次要结局
- Overall survival(2 year)
- Progression-free survival(2 year)
- Treatment-related adverse events as assessed by CTCAE v4.0(1 year)