Lung Tumour Volume Database
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Radiation: Definitive Radiotherapy
- Registration Number
- NCT00351598
- Lead Sponsor
- Trans Tasman Radiation Oncology Group
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 531
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
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Definitive Radiotherapy Patients with loco-regional, NSCLC treated by definitive radiotherapy.
- Primary Outcome Measures
Name Time Method Survival End of Study Survival duration defined as the time from date of registration until death from any cause
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
Newcastle Mater Misericordiae Hospital
🇦🇺Newcastle, New South Wales, Australia
Mater QRI
🇦🇺South Brisbane, Queensland, Australia
Westmead Hospital
🇦🇺Wentworthville, New South Wales, Australia
East Coast Cancer Centre
🇦🇺Tugun, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Alfred Hospital
🇦🇺Prahran, Victoria, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
National University Hospital
🇸🇬Singapore, Singapore
Auckland Hospital
🇳🇿Auckland, New Zealand
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia