A phase II Feasibility Study on the use of 18Fluoro-L-Thymidine and Positron Emission Tomography (FLT-PET) on Prognosis and Staging in Patients with Locoregionally Advanced Mucosal Head and Neck Squamous Cell Carcinoma

Royal Brisbane and Women's Hospital0 个研究点目标入组 10 人开始时间: 2013年2月20日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Previously untreated biopsy proven mucosal head and neck Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx
•- Stage III or IV
•- suitable for definitive radiotherapy + concurrent systemic treatment.
•- Adequate biopsy samples for EGFR and Ki-67 analyses
•- Age >=18
•- ECOG performance status <=2
•- Absolute neutrophil count >=1.5 x 109/L, platelet count >=100 x 109/L, and hemoglobin >=9 g/dL
•- Serum Bilirubin <1.25 times Upper Limit of Normal Range (ULN) and AST/ALT <=2.5 times ULN. Calculated creatinine clearance (Cockcroft-Gault) >=55 ml/min
•- Signed informed consent
•- Available for follow up for a minimum of 2 years after treatment
•- Life expectancy greater than 6 months

•- Nasopharyngeal carcinoma
•- Paranasal cavity tumours
•- Any suggestion of metastases on conventional CT scan and/or FDG-PET images
•- History of previous malignancy- excluding superficial Basal Cell Carcinoma and Squamous Cell Carcinoma
•- Other synchronous malignancies
•- Pregnant or lactating women
•- Previous radiotherapy to the head and neck region
•- High risk for poor compliance with therapy or follow-up as assessed by investigator
•- Unable to undergo PET studies

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