Lung Tumour Volume Database

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00351598
Recruitment Status : Completed
First Posted : July 13, 2006
Last Update Posted : August 4, 2014
Peter MacCallum Cancer Centre, Australia
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)

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).

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer Radiation: Definitive Radiotherapy

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
Actual Enrollment : 531 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tumour Volume as an Independent Prognostic Factor in Patients With Non-Small Cell Lung Cancer - A Protocol for a Prospective Database.
Study Start Date : September 1999
Actual Primary Completion Date : February 2009
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with loco-regional, NSCLC treated by definitive radiotherapy.
Radiation: Definitive Radiotherapy
60Gy in 6 weeks, 50Gy in 4 weeks. Each individual fraction should not exceed 2.5Gy.
Other Name: Radiation

Primary Outcome Measures :
  1. Survival [ Time Frame: End of Study ]
    Survival duration defined as the time from date of registration until death from any cause

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with loco-regional non-small cell lung cancer

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00351598

Australia, New South Wales
St George Hospital
Kogarah, New South Wales, Australia, 2217
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, Australia, 2298
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Australia, Queensland
Mater QRI
South Brisbane, Queensland, Australia, 4101
East Coast Cancer Centre
Tugun, Queensland, Australia, 4224
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Austin Health
Heidelberg, Victoria, Australia, 3081
Alfred Hospital
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
New Zealand
Auckland Hospital
Auckland, New Zealand, 1001
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Peter MacCallum Cancer Centre, Australia
Study Chair: David Ball Peter MacCallum Cancer Centre, Australia

Additional Information:
Publications of Results:
Responsible Party: Trans-Tasman Radiation Oncology Group (TROG) Identifier: NCT00351598     History of Changes
Other Study ID Numbers: TROG 99.05
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: July 2014

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Tumour Volume
Prognostic value

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms