NCT01142414撤回3 期
Randomized Phase III Trial on Postoperative Chemoradiation in Combination With Anti EGFR-Antibody Versus Postoperative Chemoradiation in Head and Neck Squamous Cell Carcinomas (HNSCC) With High Risk of Locoregional Recurrence
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Disease-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether chemotherapy given together with radiation therapy is more effective with or without panitumumab in treating patients with advanced cancer of the hypopharynx, oropharynx, larynx, or oral cavity.
PURPOSE: This randomized phase III trial is studying chemotherapy given together with radiation therapy to see how well it works compared with chemotherapy and radiation therapy given together with panitumumab in treating patients who have undergone surgery for advanced hypopharyngeal cancer, oropharyngeal cancer, laryngeal cancer, or oral cavity cancer at high risk of recurrence.
详细描述
OBJECTIVES:
Primary
- To determine if the addition of concurrently administered panitumumab to standard adjuvant chemoradiation, with 1 of 2 cisplatin-based regimens, significantly prolongs disease-free survival of patients with macroscopically completely resected, advanced squamous cell carcinoma of the hypopharynx, oropharynx, larynx, or oral cavity at high risk of recurrence.
Secondary
- To determine if the pre-surgery dose of panitumumab will alter the RNA expression of several genes and that these changes will provide additional prognostic information that can be used in future patient management. (Exploratory)
- Measure the differences in RNA expression by RNA microarray and the results analyzed to create a gene expression classifier that will be checked for outcome prediction by association with disease free survival and down regulation of the glucose metabolism as measured by FDG-PET. (Exploratory)
- To create a European biobank of biological samples which can be used for future research projects in this disease. (Exploratory)
- To predict radiation-induced normal tissue toxicity based on in vitro lymphocyte apoptosis test and SNPs analysis. (Exploratory)
- To assess the impact of radiation-induced side effects (swallowing dysfunction and xerostomia) on patient's quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary squamous cell carcinoma of the hypopharynx, oropharynx, larynx, or oral cavity
- •Stage pT1-2 pN+ or pT3-4 any pN (stage III-IVB) disease
- •No distant metastases
- •No recurrent disease
- •Resectable disease
- •Has undergone surgical resection of carcinoma
- •p16 immunohistochemistry assay performed on tissue sections taken during the surgical procedure
- •No laser surgery
- •Potentially at high-risk of locoregional recurrence, defined as fulfilling ≥ 1 of the following criteria:
- •Close surgical margins (i.e., margins 1 mm to < 5 mm)
- •R1-resection (< 1 mm) (R2 resection is considered as not eligible)
- •Extracapsular nodal extension
- •No nasopharynx, nasal cavity, or paranasal sinuses carcinomas
- •PATIENT CHARACTERISTICS:
- •WHO or ECOG performance status 0-1
- •Absolute neutrophils ≥ 1.5 x 10^9/L
- •Platelet count ≥ 100 x 10^9/L
- •Hemoglobin ≥ 10.0 g/dL
- •Bilirubin < 1.5 times upper limit of normal (ULN)
- •AST< 3 times ULN
- •Alkaline phosphatase < 3 times ULN
- •Calculated creatinine clearance ≥ 60 mL/min
- •Calcium ≤ 11.5 mg/dL or 2.9 mmol/L
- •Magnesium ≥ 1.2 mg/dL or 0.5 mmol/L
- •Fertile patients must use effective contraception methods during the study and for 6 months after the last treatment dose
- •Not pregnant or nursing
- •No known allergic or hypersensitivity reaction to any of the components of the study treatment
- •No other concurrent serious illnesses or medical conditions, including any of the following:
- •History or evidence of interstitial pneumonitis or pulmonary fibrosis
- •Unstable cardiac disease despite treatment
- •NYHA class III-IV congestive heart failure
- •Clinically significant abnormal ECG or LVEF below the institutional lower limit of normal
- •Known HIV infection or other conditions of persistent immunodeficiency
- •Significant neurologic or psychiatric disorders
- •Active uncontrolled infection
- •Active disseminated intravascular coagulation
- •Symptomatic peripheral neuropathy (CTCAE 4.0 "peripheral sensory neuropathy and paresthesia") ≥ grade 2 or ototoxicity (CTCAE 4.0 "hearing impaired") ≥ grade 2, unless due to trauma or mechanical impairment due to tumor mass
- •Other serious underlying medical conditions that could impair the ability of the patient to participate in the study
- •No other malignancy within the past 5 years other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
- •Patients who are disease-free for > 5 years allowed
- •No known drug abuse
- •No psychological, familial, sociological (e.g., severe alcohol addiction expected to hamper protocol compliance), or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy or radiotherapy for carcinoma of the head and neck
- •No prior radiotherapy to the head and neck region
- •No prior exposure to EGFR pathway-targeting therapy
- •No participation in another interventional clinical trial within the past 30 days
- •No concurrent granulocyte colony-stimulating factor (G-CSF) or erythropoietin
- •No other concurrent investigational drugs and/or anticancer treatment
排除标准
- 未提供
结局指标
主要结局
Disease-free survival
次要结局
- Overall survival
- Loco-regional control
- Incidence of acute and late toxicity (CTCAE version 4.0)
- Health-related quality of life
- Cumulative incidence of and time to distant metastases
- Cumulative incidence of and time to second cancers (all sites)
研究者
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