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CompletedNCT00351598Updated Aug 4, 2014

Lung Tumour Volume Database

An observational study in Non-Small Cell Lung Cancer, sponsored by Trans Tasman Radiation Oncology Group. Completed at 15 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-04.

Sponsored by Trans Tasman Radiation Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
531
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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.

02

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Tumour Volume
  • Prognostic value
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 531 is above the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Trans Tasman Radiation Oncology Group is the lead sponsor of 35 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with loco-regional non-small cell lung cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
531 participants (actual)

Groups and cohorts

  • 1

    Patients with loco-regional, NSCLC treated by definitive radiotherapy.

    Radiation: Definitive Radiotherapy

Interventions

  • RadiationDefinitive Radiotherapy

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

    Also known as: Radiation

06

What researchers measure

Primary outcomes

  1. Survival

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

    Time frame: End of Study

07

Study locations

15 sites
  • St George Hospital
    Kogarah, New South Wales 2217, Australia
  • Liverpool Hospital
    Liverpool, New South Wales 1871, Australia
  • Newcastle Mater Misericordiae Hospital
    Newcastle, New South Wales 2298, Australia
  • Royal Prince Alfred Hospital
    Sydney, New South Wales 2050, Australia
  • Westmead Hospital
    Wentworthville, New South Wales 2145, Australia
  • Mater QRI
    South Brisbane, Queensland 4101, Australia
  • East Coast Cancer Centre
    Tugun, Queensland 4224, Australia
  • Princess Alexandra Hospital
    Woolloongabba, Queensland 4102, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • Peter MacCallum Cancer Centre
    East Melbourne, Victoria 3002, Australia
  • Austin Health
    Heidelberg, Victoria 3081, Australia
  • Alfred Hospital
    Prahran, Victoria 3181, Australia
  • Sir Charles Gairdner Hospital
    Nedlands, Western Australia 6009, Australia
  • Auckland Hospital
    Auckland, 1001, New Zealand
  • National University Hospital
    Singapore, Singapore
08

References and documents

Publications

  • Ball DL, Fisher R, Burmeister B, Graham P, Joseph D, Penniment M, Krawitz H, Wheeler G, Poulsen M, Vinod S, McClure B. Stage is not a reliable indicator of tumor volume in non-small cell lung cancer: a preliminary analysis of the Trans-Tasman Radiation Oncology Group 99-05 database. J Thorac Oncol. 2006 Sep;1(7):667-72. PubMed 17409934 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00351598
Lead sponsor
Trans Tasman Radiation Oncology Group
Collaborators
Peter MacCallum Cancer Centre, Australia
Responsible party
Sponsor
First posted
Jul 13, 2006
Start date
Sep 1999
Primary completion
Feb 2009
Completion
Nov 2012
Last update
Aug 4, 2014

Study contacts

David Ball
study chair · Peter MacCallum Cancer Centre, Australia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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