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OpenTrials
Completed

NCT Number: NCT00351598

Lung Tumour Volume 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St George Hospital, Kogarah, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Definitive radiotherapy

Radiation

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

Other names: Radiation

Primary outcomes

  1. Survival

    Time frame: End of Study

    Survival duration defined as the time from date of registration until death from any cause

Sponsors and collaborators

Lead sponsor

Trans Tasman Radiation Oncology Group

Other

Collaborators

  • Peter MacCallum Cancer Centre, Australia

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2009
Study completion
2012
First posted
Jul 13, 2006
Registry last updated
Aug 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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