Lung Tumour Volume Database

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351598
• Other study ID #: TROG 99.05
• Status: Completed
• Phase: N/A
• First received: July 11, 2006
• Last updated: July 31, 2014
• Start date: September 1999
• Est. completion date: November 2012

Study information

• Verified date: July 2014
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 531
• Est. completion date: November 2012
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Radiation:
• Definitive Radiotherapy
60Gy in 6 weeks, 50Gy in 4 weeks. Each individual fraction should not exceed 2.5Gy.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	St George Hospital	Kogarah	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Newcastle Mater Misericordiae Hospital	Newcastle	New South Wales
Australia	Alfred Hospital	Prahran	Victoria
Australia	Mater QRI	South Brisbane	Queensland
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	East Coast Cancer Centre	Tugun	Queensland
Australia	Westmead Hospital	Wentworthville	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
New Zealand	Auckland Hospital	Auckland
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Trans-Tasman Radiation Oncology Group (TROG)	Peter MacCallum Cancer Centre, Australia

Countries where clinical trial is conducted

Australia,  New Zealand,  Singapore, 

References & Publications (1)

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 On — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival duration defined as the time from date of registration until death from any cause	End of Study	No

External Links

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