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Lung Tumour Volume Database

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00351598
Enrollment
531
Registered
2006-07-13
Start date
1999-09-30
Completion date
2012-11-30
Last updated
2014-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

Tumour Volume, Prognostic value

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.

Interventions

60Gy in 6 weeks, 50Gy in 4 weeks. Each individual fraction should not exceed 2.5Gy.

Sponsors

Peter MacCallum Cancer Centre, Australia
CollaboratorOTHER
Trans Tasman Radiation Oncology Group
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SurvivalEnd of StudySurvival duration defined as the time from date of registration until death from any cause

Countries

Australia, New Zealand, Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026