ACTRN12607000146493已完成3 期
Trans Tasman Radiation Oncology Group (TROG) 05.01 - Post-Operative Concurrent Chemo-Radiotherapy (Carboplatin) Versus Post-Operative Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck to improve loco-regional relapse
Trans Tasman Radiation Oncology Group (TROG)0 个研究点目标入组 350 人开始时间: 2007年2月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Histologically proven Squamous Cell Carcinoma
- •2. Complete macroscpoic resection of all known disease with or withour microscpoic positive margins. Surgery may consist of one or more of the following:a)Resection of the primary lesion; b) Any type of parotidectomy (superficial, total, partial, etc.); c) Any type of neck dissection(s)
- •3. High risk feature(s); high risk nodal disease and/or advanced primary disease: a) High Risk Nodal Disease
- •Intra-parotid nodal disease (any number or size, with/without extracapsular extension, with/without an identifiable index lesion)
- •b) Cervical nodal disease with a synchronous index lesion or previously resected cutaneous primary tumour (<5 years) within the corresponding nodal drainage and a mucosal primary has been excluded with at least a Computed Tomography (CT) +/- Magnetic Resonance Imaging (MRI) and panendoscopy*
- •* For cervical nodal disease to be eligible there must be at least one of the following
- •(i) > 2 nodes
- •(ii) largest node > 3cm
- •(iii) Extracapsular extension
- •c) Advanced Primary Disease (Tumor, Node, Metastasis (TNM) 6th Edition 2002) (Appendix 1)
- •T3-4 primary disease (cartilage, skeletal, muscle, bone involvement, >4cm) of the
- •head and neck including lip, nose and external auditory canal with or without nodal
- •d) In transit metastases (metastases between the primary site and the adjoining nodal basin)
- •4. Age >18 years
- •5. Written informed consent
- •6. Eastern Cooperative Oncology Group (ECOG) < 2
- •7. Absolute neutrophil count > 1.5 X 109/L, platelet count > 100 X 109/L, and haemoglobin > 10g/dL (pre-radiotherapy blood transfusion to elevate the haemoglobin > 10g/dL is permissible)
- •8. Calculated creatinine clearance (Cockcroft-Gault) >40mL/min
- •9. Available for follow-up for up to 5 years
- •10. Life expectancy greater than 6 months.
排除标准
- •1. Intercurrent illness that will interfere with either the chemotherapy or radiotherapy
- •such as immunosuppression due to medication or medical condition
- •2. Metastasis(es) below the clavicle
- •3. Previous radical radiotherapy to the head and neck, excluding treatment of an early glottic cancer > 2 years ago and superficial radiotherapy to cutaneous Squamous Cell Carcinoma (SCC) or basal cell carcinoma
- •4. High risk for poor compliance with therapy or follow-up as assessed by investigator
- •5. Pregnant or lactating women
- •6. Patients with prior cancers, except: those diagnosed > 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5%; or
- •successfully treated Level 1 cutaneous melanomas or early glottic cancer > 2 years
- •ago; or non-melanoma skin cancer; or carcinoma in situ of the cervix.
- •7. Low risk cervical nodal disease* without advanced primary disease
- •*Low risk cervical nodal disease is defined as the presence of all of the following
- •(i) single nodal metastasis,
- •(ii) < 3 cm,
- •(iii) no extracapsular extension.
研究者
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