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Trial registered on ANZCTR


Registration number
ACTRN12613000205730
Ethics application status
Approved
Date submitted
13/02/2013
Date registered
20/02/2013
Date last updated
20/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 281937 0
Nil known
Universal Trial Number (UTN)
U1111-1139-4455
Trial acronym
FLT PET Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 288343 0
Condition category
Condition code
Cancer 288694 288694 0 0
Head and neck

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
18-Fluoro-L-Thymidine (FLT)
FLT is administerd for Positron Emission Tomography (PET) for staging of mucosal head and neck cancer. We aim to compare FLT-PET staging with F-2-fluoro-2-deoxy-D-glucose (FDG) PET which is the current best non-surgical staging modality.
FLT is preferentially taken up by cells that undergo rapid proliferation. FDG is the standard tracer and is taken up by cells that utilise glucose. Cancer cells are rapidly dividing cells.
FLT is given via an injection, 60 minutes later the scan is commenced. A total of 2 FLT PET scans are performed. 1 at baseline, the other at radiotherapy week 3.
Patients will be observed for a total of 5 years.
Intervention code [1] 286510 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288854 0
Assess the feasibility of conducting a larger trial.
Timepoint [1] 288854 0
12 months from study entry
Primary outcome [2] 288911 0
Assess the sensitivity and specificity of FLT PET.
Timepoint [2] 288911 0
12 months from study entry
Secondary outcome [1] 301316 0
Response to treatment. Assessed by clinical reviews and medical imaging.
Timepoint [1] 301316 0
5 years post study entry

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 572 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 6314 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 286726 0
Hospital
Name [1] 286726 0
Royal Brisbane and Women's Hospital Foundation
Address [1] 286726 0
Butterfield Street
Herston QLD 4029
Country [1] 286726 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 285501 0
None
Name [1] 285501 0
Address [1] 285501 0
Country [1] 285501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288798 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 288798 0
Butterfield Street
Herston QLD 4029
Ethics committee country [1] 288798 0
Australia
Date submitted for ethics approval [1] 288798 0
29/08/2007
Approval date [1] 288798 0
07/01/2008
Ethics approval number [1] 288798 0
2007/125

Summary
Brief summary
This study is an observational study investigating the use of new tracer for Positron Emission Tomography (PET). This tracer is preferentially taken up by cells that undergo rapid proliferation. The study has two aims: to assess the feasibility of conducting a larger trial, and to assess the sensitivity and specificity of FLT PET. The target patient population is those with locoregionally advanced mucosal head and neck squamous cell carcinoma undergoing definitive chemoradiation. You may be eligible to join this study if you are aged 18 and over, and have a previously untreated biopsy proven mucosal head and neck Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx - Stage III or IV (TNM staging). You must be suitable for definitive radiotherapy + concurrent systemic treatment. Further details on the inclusion criteria for this study can be found in the relevant section on this form. Trial details All participants in this trial will undergo their standard cancer treatment, but with the addition of 2 18Fluoro-L-Thymidine and Positron Emission Tomography (FLT-PET) scans at baseline and at week 3 of radiotherapy. This will involve injection of FLT (study tracer) with scan commencing 60 minutes later.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37774 0
Dr Charles Lin
Address 37774 0
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country 37774 0
Australia
Phone 37774 0
+61 7 3646 8111
Fax 37774 0
+61 7 3646 4221
Email 37774 0
Jacqui_Keller@health.qld.gov.au
Contact person for public queries
Name 37775 0
Ms Jacqui Keller
Address 37775 0
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country 37775 0
Australia
Phone 37775 0
+61 7 3646 7925
Fax 37775 0
+61 7 3646 6655
Email 37775 0
Jacqui_Keller@health.qld.gov.au
Contact person for scientific queries
Name 37776 0
Dr Charles Lin
Address 37776 0
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country 37776 0
Australia
Phone 37776 0
+61 7 3646 8111
Fax 37776 0
+61 7 3646 4221
Email 37776 0
Charles_Lin@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary