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

Not Applicable

Active, not recruiting

• Conditions: Head and Neck Cancer; Cancer - Head and neck

• Registration Number: ACTRN12613000205730
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the feasibility of conducting a larger trial. [12 months from study entry];Assess the sensitivity and specificity of FLT PET.[12 months from study entry]

Secondary Outcome Measures

Name	Time	Method
Response to treatment. Assessed by clinical reviews and medical imaging.[5 years post study entry]