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Trial registered on ANZCTR


Registration number
ACTRN12611001283965
Ethics application status
Approved
Date submitted
15/12/2011
Date registered
15/12/2011
Date last updated
15/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of serial 18F-fluorodeoxyglucose (FDG) and 18F-fluorothymidine (FLT) positron emission tomography (PET) & computed tomography (CT) for candidates with non-small cell lung cancer (NSCLC)receiving radical chemo-radiation therapy
Scientific title
A prospective study to investigate the impact of serial FDG and FLT PET scans on the radiation therapy treatment of patients with NSCLC
Secondary ID [1] 273607 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lung cancer 279356 0
Condition category
Condition code
Cancer 285543 285543 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
FDG and FLT PET/CT scans at baseline, during week two and week four of therapy.
Each scan involves the injection of a radiotracer (FDG or FLT).
Each scan is approximately 30 minutes in duration.
Patients will be recruited over a five year period.
Intervention code [1] 283863 0
Not applicable
Comparator / control treatment
Observational single arm study, standard treatment adminstered.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286109 0
To simulate the administration of biologically adapted radiation therapy (BART) to patients with NSCLC using information gained from interim FLT & FDG PET/CT scans.
Timepoint [1] 286109 0
Following recruitment of all patients
Secondary outcome [1] 295166 0
To determine the role of interim FLT & FDG PET/CT scans as biomarkers of patient prognosis.
Timepoint [1] 295166 0
Overall survival (OS): time from first RT treatment until death from any cause.
Progression free survival (PFS): time from first RT until progression (local, regional & distant).
OS and PFS will be assessed clinically and with diagnostic imaging, including a follow-up FDG PET/CT scan.

Eligibility
Key inclusion criteria
Written informed consent provided.
Histologically or cytologically confirmed NSCLC.
Candidate for radical RT (60Gy) & concomitant chemotherapy (standard regimen determined by medical oncologist).
Stage I - III disease (TNM 7th edition).
ECOG performance status 0-1.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Received previous thoracic RT or a complete macroscopic excision of tumour.
Pregnancy (Women of child-bearing age to ensure adequate contraceptive measures).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
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)

Funding & Sponsors
Funding source category [1] 284342 0
Government body
Name [1] 284342 0
NHMRC
Address [1] 284342 0
GPO Box 1421
Canberra
ACT
2601
Country [1] 284342 0
Australia
Funding source category [2] 284343 0
Government body
Name [2] 284343 0
Victorian Cancer Agency
Address [2] 284343 0
12 Victoria Street
Carlton
Melbourne
VIC 3053
Country [2] 284343 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
St Andrews Place
East Melbourne
VIC 3001
Country
Australia
Secondary sponsor category [1] 283283 0
University
Name [1] 283283 0
University of Melbourne
Address [1] 283283 0
Grattan Street
Parkville
Melbourne
VIC 3010
Country [1] 283283 0
Australia
Other collaborator category [1] 260377 0
University
Name [1] 260377 0
Monash University
Address [1] 260377 0
Dept Medical Imaging and Radiation Sciences
Wellington Road
Clayton,
VIC 3800
Country [1] 260377 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286300 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 286300 0
St Andrews Place
East Melbourne
VIC 3001
Ethics committee country [1] 286300 0
Australia
Date submitted for ethics approval [1] 286300 0
Approval date [1] 286300 0
14/10/2008
Ethics approval number [1] 286300 0
08/40
Ethics committee name [2] 286338 0
Monash University
Ethics committee address [2] 286338 0
Wellington Road
Clayton
VIC
3800
Ethics committee country [2] 286338 0
Australia
Date submitted for ethics approval [2] 286338 0
Approval date [2] 286338 0
23/10/2008
Ethics approval number [2] 286338 0
2008001483

Summary
Brief summary
This study aims to prospectively explore the anatomical and biological characteristics of non-small cell lung cancers (NSCLC) in patients receiving combined radiation therapy (RT)-chemotherapy treatment with a curative intent. Patients will undergo PET/CT scans during the course of their treatment using two different PET tracers. The first tracer, 18F-FDG, is a proven tracer in current clinical use used to detect glucose metabolism. The second, 18F-FLT, is a novel tracer that can visualize cellular division rates in tumour compared to normal tissue.
Trial website
Trial related presentations / publications
Everitt S, Hicks R, Hicks R, Ball D, Kron T, Schneider-Kolsky M, Binns D, Walter T, Mac Manus M, Imaging cellular proliferation during chemo-radiotherapy: A pilot study of serial 18F-FLT-PET/CT imaging for non-small cell lung cancer, International Journal of Radiation Oncology Biology Physics, 2009, 75(4) pp1098-1104 (IF 4.290)
Everitt S J, Hicks RJ, Kron T, Schneider-Kolsky M, Binns D, Walter T, Ball D, Mac Manus M, Imaging Cellular Proliferation During Therapy: A Pilot Study of Serial 18F-FLT-PET Scanning During Chemoradiation for Non-small Cell Lung Cancer Journal of Thoracic Oncology, 2008, 3(11) Supp 4, A121 (IF 1.429)
Everitt S, A prospective study investigating the impact of serial PET/CT scans on the radiation therapy treatment of patients with lung cancer, Victorian Cancer Agency Conference, Melbourne August 2010, (Invited speaker)
Everitt S, J Callahan, T Kron, R Hicks, D Ball, M Schneider-Kolsky and M MacManus, Biologically guided radiation therapy: quality assurance and resource implications in longitudinal PET/CT studies; ESTRO/EANM: Molecular Imaging and Radiation Oncology; Brussels; Belgium March 2010
Everitt S, Hicks R, Ball D, Kron T, Schneider-Kolsky M, Binns D, Walter T, Mac Manus M, Serial 18F-FLT-PET/CT scanning to monitor cellular proliferation in NSCLC during chemoRT, European Association of Nuclear Medicine, Spain, October 2009
Everitt S, Hicks R, Ball D, Kron T, Schneider-Kolsky M, Binns D, Walter T, Mac Manus M, Monitoring cellular proliferation during chemo-radiotherapy: A pilot study of serial 18F-FLTPET/CT scanning for Non-Small Cell Lung Cancer, Royal Australian and New Zealand College of Radiologists and Faculty of Radiation Oncology/Australian Institute of Radiography/Australasian College of Physical Scientists and Engineers in Medicine Combined Scientific Meeting, Brisbane, Australia, October 2009
Everitt S, Hicks R, Ball D, Kron T, Schneider-Kolsky M, Binns D, Walter T, Mac Manus M, Monitoring cellular proliferation during chemo-radiotherapy: A pilot study of serial 18F-FLT-PET/CT scanning for Non-Small Cell Lung Cancer, 39th ASM Australia New Zealand Society of Nuclear Medicine, Sydney, March 2009
Public notes

Contacts
Principal investigator
Name 33513 0
Address 33513 0
Country 33513 0
Phone 33513 0
Fax 33513 0
Email 33513 0
Contact person for public queries
Name 16760 0
Sarah Everitt
Address 16760 0
Radiation Therapy
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street
VIC 8006
Country 16760 0
Australia
Phone 16760 0
61 3 96561111
Fax 16760 0
Email 16760 0
sarah.everitt@petermac.org
Contact person for scientific queries
Name 7688 0
Sarah Everitt
Address 7688 0
Radiation Therapy
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street
VIC 8006
Country 7688 0
Australia
Phone 7688 0
61 3 96561111
Fax 7688 0
Email 7688 0
sarah.everitt@petermac.org

No data has been provided for results reporting
Summary results
Not applicable