Lung Tumour Volume Database
July 31, 2014 updated by: Trans Tasman Radiation Oncology Group
Tumour Volume as an Independent Prognostic Factor in Patients With Non-Small Cell Lung Cancer - A Protocol for a Prospective Database.
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients with locoregional non small cell lung cancer are registered on study after tumour volumes are outlined by a radiologist and prior to the commencement of any treatment.
All patients must have recorded the volume of disease in the primary tumour (and of involved nodes > 1 cm diameter) as measured from a CT scan performed according to a standard set of conditions.
Following registration patients are treated with Definitive radiotherapy with or without chemotherapy. Follow-up will occur with the collection of a minimum amount of data every 12 months from the date of registration on study.
Quality Assurance procedures will be implemented with each site that participates in the study.
Study Type
Observational
Enrollment (Actual)
531
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Kogarah, New South Wales, Australia, 2217
- St George Hospital
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Liverpool, New South Wales, Australia, 1871
- Liverpool Hospital
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Newcastle, New South Wales, Australia, 2298
- Newcastle Mater Misericordiae Hospital
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Sydney, New South Wales, Australia, 2050
- Royal Prince Alfred Hospital
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Wentworthville, New South Wales, Australia, 2145
- Westmead Hospital
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Mater QRI
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Tugun, Queensland, Australia, 4224
- East Coast Cancer Centre
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Victoria
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East Melbourne, Victoria, Australia, 3002
- Peter MacCallum Cancer Centre
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Heidelberg, Victoria, Australia, 3081
- Austin Health
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Prahran, Victoria, Australia, 3181
- Alfred Hospital
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
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Auckland, New Zealand, 1001
- Auckland Hospital
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Singapore, Singapore
- National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with loco-regional non-small cell lung cancer
Description
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
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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1
Patients with loco-regional, NSCLC treated by definitive radiotherapy.
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60Gy in 6 weeks, 50Gy in 4 weeks.
Each individual fraction should not exceed 2.5Gy.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Survival
Time Frame: End of Study
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Survival duration defined as the time from date of registration until death from any cause
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End of Study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: David Ball, Peter MacCallum Cancer Centre, Australia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1999
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
July 11, 2006
First Submitted That Met QC Criteria
July 11, 2006
First Posted (Estimate)
July 13, 2006
Study Record Updates
Last Update Posted (Estimate)
August 4, 2014
Last Update Submitted That Met QC Criteria
July 31, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TROG 99.05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.