Lung Tumour Volume Database

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tumour Volume as an Independent Prognostic Factor in Patients With Non-Small Cell Lung Cancer - A Protocol for a Prospective Database.

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Definitive Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with loco-regional, NSCLC treated by definitive radiotherapy. | Radiation: Definitive Radiotherapy<br>* 60Gy in 6 weeks, 50Gy in 4 weeks. Each individual fraction should not exceed 2.5Gy.<br>* Other names: Radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival duration defined as the time from date of registration until death from any cause | End of Study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tumour Volume, Prognostic value