Lung Tumour Volume Database

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Trans-Tasman Radiation Oncology Group (TROG).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Peter MacCallum Cancer Centre, Australia
Information provided by:
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00351598
First received: July 11, 2006
Last updated: October 21, 2008
Last verified: October 2008
  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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


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

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.
Other Name: Radiation

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
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
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

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

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

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

ClinicalTrials.gov processed this record on April 22, 2014