NCT00351598

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
531

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1999

Longer than P75 for all trials

Geographic Reach
3 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

August 4, 2014

Status Verified

July 1, 2014

Enrollment Period

9.4 years

First QC Date

July 11, 2006

Last Update Submit

July 31, 2014

Conditions

Non-Small Cell Lung Cancer

Keywords

Tumour VolumePrognostic value

Outcome Measures

Primary Outcomes (1)

  • Survival

    Survival duration defined as the time from date of registration until death from any cause

    End of Study

Study Arms (1)

1

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

Radiation: Definitive Radiotherapy

Interventions

Definitive RadiotherapyRADIATION

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

Also known as: Radiation
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with loco-regional non-small cell lung cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 1871, Australia

Location

Newcastle Mater Misericordiae Hospital

Newcastle, New South Wales, 2298, Australia

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Westmead Hospital

Wentworthville, New South Wales, 2145, Australia

Location

Mater QRI

South Brisbane, Queensland, 4101, Australia

Location

East Coast Cancer Centre

Tugun, Queensland, 4224, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

Austin Health

Heidelberg, Victoria, 3081, Australia

Location

Alfred Hospital

Prahran, Victoria, 3181, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Auckland Hospital

Auckland, 1001, New Zealand

Location

National University Hospital

Singapore, Singapore

Location

Related 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 Oncology Group 99-05 database. J Thorac Oncol. 2006 Sep;1(7):667-72.

    PMID: 17409934RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiation

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • David Ball

    Peter MacCallum Cancer Centre, Australia

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 13, 2006

Study Start

September 1, 1999

Primary Completion

February 1, 2009

Study Completion

November 1, 2012

Last Updated

August 4, 2014

Record last verified: 2014-07

Locations

AU(13)NZ(1)SG(1)