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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00351598




Registration number
NCT00351598
Ethics application status
Date submitted
11/07/2006
Date registered
13/07/2006
Date last updated
4/08/2014

Titles & IDs
Public title
Lung Tumour Volume Database
Scientific title
Tumour Volume as an Independent Prognostic Factor in Patients With Non-Small Cell Lung Cancer - A Protocol for a Prospective Database.
Secondary ID [1] 0 0
TROG 99.05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - Definitive Radiotherapy

1 - Patients with loco-regional, NSCLC treated by definitive radiotherapy.


Treatment: Other: Definitive Radiotherapy
60Gy in 6 weeks, 50Gy in 4 weeks. Each individual fraction should not exceed 2.5Gy.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival
Timepoint [1] 0 0
End of Study

Eligibility
Key inclusion criteria
Must satisfy ALL of the following

* NSCLC - histological or cytological diagnosis of non-small cell lung cancer
* Intra-thoracic disease - disease is confined to the primary site, with or without intrathoracic lymph nodes
* CT planning - CT imaging of the thorax has been performed as part of the planning procedure
* Definitive radiotherapy - it is planned to give definitive radiotherapy with or without chemotherapy (prior to, during or after radiotherapy). Definitive radiotherapy is defined as 60 Gy in 6 weeks, 50 Gy in 4 weeks or at least the equivalent of either of these. The size of each individual; fraction should not exceed 2.5 Gy.
* Measurable disease - the primary tumour and nodes with maximum diameter greater than 1cm represent measurable disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A patient satisfying ANY of the following is ineligible

* Symptomatic or radiological evidence of metastatic disease
* Prior treatment for non-small cell lung cancer
* Surgical resection is part of initial treatment
* Palliative radiotherapy planned

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
531
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Newcastle Mater Misericordiae Hospital - Newcastle
Recruitment hospital [4] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [5] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [6] 0 0
Mater QRI - South Brisbane
Recruitment hospital [7] 0 0
East Coast Cancer Centre - Tugun
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [11] 0 0
Austin Health - Heidelberg
Recruitment hospital [12] 0 0
Alfred Hospital - Prahran
Recruitment hospital [13] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
1871 - Liverpool
Recruitment postcode(s) [3] 0 0
2298 - Newcastle
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Wentworthville
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
4224 - Tugun
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
3002 - East Melbourne
Recruitment postcode(s) [11] 0 0
3081 - Heidelberg
Recruitment postcode(s) [12] 0 0
3181 - Prahran
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peter MacCallum Cancer Centre, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The main aim is to determine, in patients with locoregional, non-small cell lung cancer (NSCLC) treated by definitive radiotherapy, the influence on survival of the volume of primary tumour, as measured from CT imaging, after adjusting for the effect of the current TNM staging system and other known prognostic factors (especially ECOG performance and weight loss).
Trial website
https://clinicaltrials.gov/study/NCT00351598
Trial related presentations / publications
Ball DL, Fisher R, Burmeister B, Graham P, Joseph D, Penniment M, Krawitz H, Wheeler G, Poulsen M, Vinod S, McClure B. Stage is not a reliable indicator of tumor volume in non-small cell lung cancer: a preliminary analysis of the Trans-Tasman Radiation Oncology Group 99-05 database. J Thorac Oncol. 2006 Sep;1(7):667-72.
Public notes

Contacts
Principal investigator
Name 0 0
David Ball
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00351598