Postoperative Concurrent Chemoradiotherapy Combined With Recombinant Human Endostatin for High-risk Early Stage Cervical Cancer: A Phase II Pilot Study (ChESS).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 3-year Disease-free survival
研究概览
简要总结
To assess the efficacy and safety of postoperative concurrent chemoradiotherapy combined with recombinant human endostatin (Endostar) in patients with high-risk early stage cervical cancer.
详细描述
This is a pilot phase 2, single arm study to assess the efficacy and safety of concurrent chemoradiotherapy combined with recombinant human endostatin (Endostar) in early stage cervical cancer patients with high risk factor(s).
Postoperative pelvic radiotherapy starts 2-3 weeks after surgery. Intensity modulated radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total prescription dose of 45-50Gy to PTV region. The external beam radiotherapy should be completed within 6 weeks. Concurrent chemotherapy consists of cisplatin (75 mg/m2, day 1-3) and 5-fluorouracil (5-FU; 1000mg/m2/day, civ, day 1-4) for 2 cycles every 3 weeks. Recombinant human endostatin (Endostar,15mg/m2/d, civ, d1-7) is applied 3 days before the concurrent chemoradiotherapy for 2 cycles every 3 weeks.
Aimed to recruit total of 120 cases in this single arm study. The primary endpoint is 3-year disease-free survival and acute toxicity. Secondary endpoints include time to distant metastasis survival, local-regional recurrence free survival, 3 and 5-year overall survival, and safety and tolerability. Quality of life will be evaluated with EORTC-Q30.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 70 years.
- •Histologically confirmed adenocarcinoma or squamous cervical carcinomas.
- •Chest CT scan and ultrasound must be done prior to surgery as to rule out distant metastasis.
- •Operable patients with clinical diagnosis of FIGO stage IB-IIA cervical cancer.
- •Complete radical hysterectomy of cervical cancer is mandatory. All gross diseases must have been removed at the end of surgery. All surgical margins of resection must be negative for tumor. Para-aortic lymph node sampling is performed according to gynaecologist decision.
- •Patients with one of these risk factors:positive pelvic nodes, parametrial invasion, positive surgical margin.OR patients with at least two of following risk factors: tumor size≥4cm,lymphovascular space invasion,stromal invasion≥1/
- •Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group).
- •Adequate organ function is needed, including cardio-respiratory, hepato-renal and hematological reserves: Absolute neutrophil count (ANC)≥1.5×109/L;Platelet count≥100×109/L; ASAT&ALST<1.5 times upper limit of normal (ULN) (With hepatic metastases, ASAT&ALST<5.0 times upper limit of normal);Bilirubin <1.5 times ULN;Creatinine≤1.25×ULN or Creatinine clearance≥50 mL/min.
- •Signed written informed consent prior to study entry.
排除标准
- •Previous radiation or chemotherapy treatment or major pelvic surgery.
- •Patients with distant metastasis confirmed by imaging or pathology.
- •Other uncured malignant tumors in the past five years, except the cured skin basal cell carcinoma and breast carcinoma in situ.
- •Any prior anticancer therapy.
- •Unable to tolerate postoperative concurrent chemoradiotherapy.
- •Patients with evidence of being allergic to fluorouracil, cisplatin or Endostar.
- •Patients with serious comorbidity that might potentially influence the practice of protocol, including severe infection, myocardial infarction, severe arrhythmia, severe cerebrovascular disease, severe mental disorder, etc.
- •Patients with Heart related adverse events or thrombotic events in the past 6 months.
- •Patients with hepatitis B, hepatitis C and human immunodeficiency virus (HIV) or any other active viral infections.
- •Participate in other clinical researchers.
- •The estimated survival<3 months;
研究组 & 干预措施
Chemoradiotherapy + Endostar
Chemoradiotherapy with Endostar：
- Chemoradiotherapy: pelvic radiotherapy with concurrent chemotherapy that consisted of cisplatin (75 mg/m2, day 1-3) and 5-fluorouracil (5-FU; 1000mg/m2/day,civ, day 1-4) for 2 cycles every 3 weeks.
- Endostar: recombinant human endostatin (15mg/m2/d, civ, d1-7) is given 3 days before the chemotherapy every 3 weeks, total of two cycles during chemoradiotherapy course.
干预措施: Chemoradiotherapy+ Endostar (Combination Product)
结局指标
主要结局
3-year Disease-free survival
时间窗: 3 years
From date of surgery until the date of first documented local-regional progression or distant metastasis (determined by CT or MRI scan and/or biopsy) or death (from any cause) assessed up to three years.
Acute toxicity
时间窗: 3 months
Evaluate the treatment induced toxicity according to CTCAE 4.0 during the time of chemoradiotherapy and Endostar which starts from the first day of Endostar and lasts three months.
次要结局
- 5-year overall survival rate(5 years)
- Time to distant metastasis survival(3 years)
- Local-regional recurrence free survival(3 years)
- Quality of Life (QoL)(3 years)
- 3-year overall survival rate(3 years)
研究者
Ke Gu
Associate professor
Nanjing Medical University