NCT00347256撤回不适用
Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 主要终点
- Local control of cancer at two years post treatment
研究概览
简要总结
The purpose of this study is to determine the efficacy of concurrent chemotherapy and radiotherapy pre-operatively in patients with advanced paranasal sinus cancer. The main objectives of this study are: 1) to measure the rate of complete response to preoperative chemoradiation and 2) to study the efficacy of combining preoperative chemoradiation and surgery in terms of local control of the cancer two years post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Karnofsky Performance Score: >= 60
- •Creatinin clearance >= 50 ml/min or serum creatinine =<1.5 mg/dl
- •Total bilirubin, AST, ALT =< 1.5 X laboratory uln
- •ANC >= 2000/mm3, platelets >= 100,000/mm3
- •Serum calcium within normal range
- •T3 or T4 state tumors of paranasal sinuses
- •Squamous cell carcinoma, adenocarcinoma, high-grade mucoepidermoid carcinoma, sinonasal undifferentiated carcinoma
排除标准
- •History of other malignancy in the last 3 years
- •Other serious comorbidity that may significantly reduce the survival in next 5 years
- •Pregnant or lactating women
- •History of radiation to the head and neck region
- •Paranasal sinus tumor is recurrent after prior treatment
- •Presence of cervical node metastasis
- •Presence of distant metastasis
- •Advanced nasopharyngeal malignancy with sphenoid or posterior ethmoid invasion
结局指标
主要结局
Local control of cancer at two years post treatment
Response to preoperative chemoradiation
次要结局
- Estimation of the proportion of the inoperable tumors which become operable after chemoradiation
- Identification of factors that are associated with inoperability
- Estimation of the overall survival and cumulative incidence of death due to disease at 2 years
- Determination of the acute and long-term toxicity, particularly ophthalmologic complications, and surgical morbidity associated with this regimen
- Measurement of the accuracy of conventional imaging techniques (CT, MRI) compared with the addition of PET imaging in predicting the response to chemoradiation therapy.
研究者
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