Lung Tumour Volume Database

NCT ID: NCT00351598

Last Updated: 2014-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

531 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-09-30

Study Completion Date

2012-11-30

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.

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

Definitive Radiotherapy

Intervention Type RADIATION

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

Interventions

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Definitive Radiotherapy

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

Intervention Type RADIATION

Other Intervention Names

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Radiation

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peter MacCallum Cancer Centre, Australia

OTHER

Sponsor Role collaborator

Trans Tasman Radiation Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Ball

Role: STUDY_CHAIR

Peter MacCallum Cancer Centre, Australia

Locations

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St George Hospital

Kogarah, New South Wales, Australia

Site Status

Liverpool Hospital

Liverpool, New South Wales, Australia

Site Status

Newcastle Mater Misericordiae Hospital

Newcastle, New South Wales, Australia

Site Status

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Site Status

Westmead Hospital

Wentworthville, New South Wales, Australia

Site Status

Mater QRI

South Brisbane, Queensland, Australia

Site Status

East Coast Cancer Centre

Tugun, Queensland, Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

Site Status

Austin Health

Heidelberg, Victoria, Australia

Site Status

Alfred Hospital

Prahran, Victoria, Australia

Site Status

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status

Auckland Hospital

Auckland, , New Zealand

Site Status

National University Hospital

Singapore, , Singapore

Site Status

Countries

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Australia New Zealand Singapore

References

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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.

Reference Type RESULT
PMID: 17409934 (View on PubMed)

Related Links

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http://www.trog.com.au

Click here for more information about this study on the TROG official website

Other Identifiers

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TROG 99.05

Identifier Type: -

Identifier Source: org_study_id

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