Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
试验速览
- 阶段
- 3 期
- 入组人数
- 282
- 试验地点
- 21
- 主要终点
- Overall survival
研究概览
简要总结
A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC).
详细描述
The objective of this trial is to determine whether Cetuximab and radiation preceded by an induction chemotherapy, may be superior to an established chemoradiation program for HNC (RTOG regimen, Adelstein DJ J.Clin.Oncol. 2003;21:92-98).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age
- •Histologically or cytologically confirmed diagnosis of HNSCC
- •Stage III/IV, not suitable for surgery (definitive cure rate improbable, technically unresectable or medical contraindication for surgery)
- •At least one uni-dimensional measurable lesion either by CT scan or MRI
- •Signed written informed consents prior to beginning protocol
- •Specific procedures:
- •Tumor tissue available for immunohistochemical staining of EGFR expression and HPV
- •Life expectancy of > 3 months at study entry
- •ECOG Performance Status of <2 at study entry.
- •Effective contraception if risk of conception exists.
- •Neutrophils > 2.0/mm³, platelet count > 100,000/mm³, and hemoglobin > 10 g/dl
- •Normal liver function
- •Serum creatinine > 1.25 x ULN and/or creatinine clearance > 60 ml/min
排除标准
- •Prior systemic chemotherapy and/or radiotherapy
- •Known peripheral neuropathy > grade 2 NCI-CTC version 3.0
- •Known chronic heart failure
- •Prior surgery, excluding prior diagnostic biopsy
- •Known drug abuse
- •Active uncontrolled infection
- •Other concomitant anticancer therapy
- •Distant metastasis
- •Concurrent chronic systemic immune therapy, chemotherapy for disease other than cancer, or hormone therapy not indicated in the study protocol
- •Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months before study entry
- •Medical or psychological condition that would not permit the patient to complete the trial or sign informed consent
- •Nasopharyngeal carcinoma WHO type II or III
- •Known allergic reaction against any of the components of the treatment
- •Pregnancy (absence confirmed by beta-HCG test) or lactation period
- •Any prior or on-going investigational medication
- •Previous or current malignancy except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
研究组 & 干预措施
ARM A
Induction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006)
干预措施: docetaxel - cisplatin - 5-fluorouracil (Drug)
ARM A
Induction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006)
干预措施: radiotherapy (Radiation)
ARM A
Induction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006)
干预措施: cetuximab (Drug)
ARM B
RT + Cddp (RTOG, Adelstein, J Clin Oncol 2003)
干预措施: cisplatin (Drug)
ARM B
RT + Cddp (RTOG, Adelstein, J Clin Oncol 2003)
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Overall survival
时间窗: 5 years
次要结局
- Progression free survival(5 years)
- Response rate(5 years)
- Incidence of acute and late toxicities in the two arms(5 years)
- Locoregional control(5 years)
研究者
MARCO MERLANO
MD
Gruppo Oncologico del Nord-Ovest