Single-agent Capecitabine as Metronomic Chemotherapy in LAHNSCC (CMHN)
Single-agent Capecitabine as Metronomic Chemotherapy in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (CMHN):A Phase III, Multicentre, Randomised Controlled Trial
研究概览
详细说明
The standard treatment for resectable locoregionally advanced squamous cell carcinoma of the head and the neck (LAHNSCC) is a regimen consisting of radical surgery plus radiotherapy or concurrent chemoradiotherapy. And induction chemotherapy plus radical radiotherapy or concurrent chemoradiotherapy is also recommended for locoregionally advanced squamous cell carcinoma of larynx and hypopharynx. With the extensive application of comprehensive treatment, the 5-year overall survival of LAHNSCC has not reached 50% yet. So, it is urgent to explore a regimen with high efficiency and low toxicity on the basis of existing standard treatment.
Two retrospective studies found that the metronomic use of orally administered fluorouracil drugs following the reference treatment significantly improved prognosis in LAHNSCC. And capecitabine is one kind of the oral fluorouracil drugs, which has high efficiency and low toxicity. Indeed, metronomic capecitabine maintenance was shown to be effective in patients with breast cancer, colorectal cancer, and nasopharyngeal carcinoma in phase III trials.
The abovementioned studies suggested the promising use of metronomic capecitabine in LAHNSCC. However, there has been no randomized trials in this field. Therefore, we initiated a randomized phase III trial to investigate the efficacy and safety of the addition of metronomic capecitabine to the standard treatment in LAHNSCC.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Ying Sun, M.D.
- 电话号码:+86-(020)-87343816
- 邮箱:sunying@sysucc.org.cn
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510060
- 招聘中
- Sun Yat-sen University Cancer Center
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接触:
- Ying Sun, M.D.
- 电话号码:+86-(020)-87343816
- 邮箱:sunying@sysucc.org.cn
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Performance status of ECOG grade 0 or 1.
- Tumor staged as III-IV (as defined by the 8th AJCC edition), with newly histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, larynx or hypopharynx.
Complete one of the following treatments:
- Radical surgery plus radiotherapy or concurrent chemoradiotherapy
- Neoadjuvant therapy plus radical radiotherapy or concurrent chemoradiotherapy
- Concurrent chemoradiotherapy
- Postoperative radiotherapy started within 4 to 8 weeks after completion of radical surgery.
- Within 4 to 8 weeks after completion of the last radiation dose.
- No clinical evidence of persistent locoregional disease or distant metastases before enrollment.
- Adequate hematologic (neutrophil count > 1.5×10^9/L, hemoglobin > 90g/L and platelet count > 100×10^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase ≤ 2.5×ULN) and renal function (creatinine clearance ≥ 50 ml/min).
- Patients must be appraised of the investigational nature of the study and provide written informed consent.
Exclusion Criteria:
- p16 positive.
- Patients who were known to be intolerable or allergic to capecitabine.
- Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- Prior surgery, chemotherapy, radiotherapy or other anti-tumor treatments (except diagnostic) to primary tumor or nodes before the standard therapy.
- Patients who received surgery treatment, biotherapy or immunotherapy during radiotherapy.
- Patients who are receiving or highly likely to receive other chemotherapy treatment, biotherapy or immunotherapy after radiotherapy.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:Clinical observation
The standard treatment followed by clinical observation.
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实验性的:Metronomic capecitabine
The standard treatment followed by a maintenance therapy with capecitabine (650 mg/m2 bid, d1-21, q3w) for 1 year.
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Metronomic capecitabine (650 mg/m2 bid, d1-21, q3w) for 1 year
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Progression-free survival
大体时间:2 years
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PFS will be measured from the day of randomization until treatment failure, death from any cause, or the last follow-up visit, whichever occurred first.
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Overall survival
大体时间:2 years
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OS will be measured from the day of randomization until death due to any cause, or the last follow-up visit.
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2 years
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Distant failure-free survival
大体时间:2 years
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DFFS will be measured from the day of randomization until death until distant metastasis, or the last follow-up visit.
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2 years
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Locoregional failure-free survival
大体时间:2 years
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LRFFS will be measured from the day of randomization until death until local and/or regional recurrence, or the last follow-up visit.
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2 years
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Adverse events
大体时间:Up to 2 years
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The incidence of capecitabine-related and other adverse events.
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Up to 2 years
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Patient reported quality-of-life score
大体时间:Up to 2 years
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Patient reported quality of life would be evaluated using the Quality of Life Questionnaire-Core 30 module (QLQ-C30).
The score is between 0-100, and the higher score means worse quality of life.
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Up to 2 years
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合作者和调查者
合作者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Capecitabine的临床试验
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AstraZenecaSWOG Clinical Trials Partnerships; Daiichi Sankyo招聘中乳腺癌美国, 中国, 丹麦, 英国, 大韩民国, 加拿大, 德国, 意大利, 比利时, 西班牙, 日本, 法国, 台湾, 希腊, 巴西, 瑞典, 波多黎各
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AstraZenecaDaiichi Sankyo招聘中乳腺癌中国, 美国, 意大利, 西班牙, 英国, 大韩民国, 加拿大, 德国, 波兰, 比利时, 日本, 越南, 保加利亚, 法国, 巴西, 印度, 马来西亚, 台湾, 泰国, 匈牙利, 澳大利亚, 奥地利, 火鸡, 香港, 瑞士, 新加坡