Lung Tumour Volume Database - Full Text View

Sponsors and Collaborators:	Trans-Tasman Radiation Oncology Group (TROG) Peter MacCallum Cancer Centre, Australia
Information provided by:	Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:	NCT00351598

Purpose

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	Intervention
Non-Small Cell Lung Cancer	Radiation: Definitive Radiotherapy

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Tumour Volume as an Independent Prognostic Factor in Patients With Non-Small Cell Lung Cancer - A Protocol for a Prospective Database.

Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	518
Study Start Date:	September 1999
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with loco-regional non-small cell lung cancer

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351598

Locations

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

Sponsors and Collaborators

Trans-Tasman Radiation Oncology Group (TROG)

Peter MacCallum Cancer Centre, Australia

Investigators

Study Chair:

David Ball

Peter MacCallum Cancer Centre, Australia

More Information

Click here for more information about this study on the TROG official website This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Responsible Party:	Trans Tasman Radiation Oncology Group (TROG) ( Associate Professor David Ball )
Study ID Numbers:	TROG 99.05
Study First Received:	July 11, 2006
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00351598
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):

Tumour Volume
Prognostic value

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009