A Prospective Randomized Controlled Clinical Trial of Capecitabine Treatment in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck After Radiotherapy: Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- PFS (progression free survival)
研究概览
简要总结
This prospective randomized controlled clinical Trial will be performed in patients with locally advanced squamous cell carcinoma of the head and neck. The objectives of the trial are to compare the efficacy and safety of Capecitabine treatment with placebo as adjuvant therapy to patients who have received radiotherapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically type： squamous cell carcinoma
- •head and neck squamous cell carcinoma (HNSCC), Tumor staged as III to IVb (according to the 8th AJCC edition).
- •Eastern cooperative oncology group (ECOG) performance status 0 or 1
- •Age between 18 and 65 years old
- •Prior treatment with chemo-radiotherapy (CRT) based Platinum drugs.
- •Adequate marrow: WBC count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- •Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.
- •Adequate renal function: creatinine clearance ≥60 ml/min.
- •Patients must be informed of the investigational nature of this study and give written informed consent.
排除标准
- •Nasopharyngeal carcinoma and/or salivary gland carcinoma.
- •Any other malignancy (except for primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ)
- •currently recurrent of metastatic disease
- •received research drug in 4 weeks
- •Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
- •Severe hematological abnormality and intolerance to chemotherapy
- •Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
- •Pregnancy or breast feeding
- •patients who cannot obey to completion of the study
研究组 & 干预措施
the treatment arm
1000-1250 mg/m2 orally twice daily for 14 days followed by a 1-week rest period, given as 3- week cycles for a total of 6 cycles .
it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Capecitabine (Drug)
结局指标
主要结局
PFS (progression free survival)
时间窗: 3-year
PFS is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.
次要结局
- Locoregional failure-free survival(3-year)
- Distant failure-free survival(3-year)
- QoL(quality of life)(3-year)
- Overall survival(3-year)
研究者
Chen Xiaozhong
Clinical Professor
Zhejiang Cancer Hospital