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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
Sex
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
23/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
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
Country [1] 284342 0
Australia
Funding source category [2] 284343 0
Government body
Name [2] 284343 0
Victorian Cancer Agency
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
[email protected]
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Everitt S, Ball D, Hicks R, Callahan J, Plumridge ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AISpleen Volume Variation in Patients with Locally Advanced Non-Small Cell Lung Cancer Receiving Platinum-Based Chemo-Radiotherapy2015https://doi.org/10.1371/journal.pone.0142608
EmbaseCone-beam computed tomography for lung cancer - validation with CT and monitoring tumour response during chemo-radiation therapy.2017https://dx.doi.org/10.1111/1754-9485.12551
Dimensions AIAcute radiation oesophagitis associated with 2-deoxy-2-[18F]fluoro-d-glucose uptake on positron emission tomography/CT during chemo-radiation therapy in patients with non-small-cell lung cancer2017https://doi.org/10.1111/1754-9485.12631
EmbaseWhat18F-FDG PET response-assessment method best predicts survival after curative-intent chemoradiation in non-small cell lung cancer: EORTC, PERCIST, Peter Mac criteria, or Deauville criteria?.2019https://dx.doi.org/10.2967/jnumed.118.214148
EmbaseNodal metabolic tumour volume on baseline 18F-FDG PET/CT and overall survival in stage II and III NSCLC patients undergoing curative-intent chemoradiotherapy/radiotherapy.2021https://dx.doi.org/10.1111/1754-9485.13294
EmbaseBlood-Derived Extracellular Vesicle-Associated miR-3182 Detects Non-Small Cell Lung Cancer Patients.2022https://dx.doi.org/10.3390/cancers14010257
N.B. These documents automatically identified may not have been verified by the study sponsor.