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Tumour Volume as an Independent Prognostic Factor in Patients With Non-Small Cell Lung Cancer - A Protocol for a Prospective Database.


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

Tumour Volume as an Independent Prognostic Factor in Patients With Non-Small Cell Lung Cancer - A Protocol for a Prospective Database.


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

David Ball

Investigator Role:

Study Chair

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia

Authority:

Australia: Human Research Ethics Committee

Study ID:

TROG 99.05

NCT ID:

NCT00351598

Start Date:

September 1999

Completion Date:

December 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Tumour Volume
  • Prognostic value
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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