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 sites10 target enrollmentFebruary 20, 2013

Overview

No summary available.

Registry

who.int

Start Date

February 20, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Observational

Sex

All

Sponsor

•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

•\- 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