Lung Tumour Volume Database | NCT00351598

Studies
Lung Tumour Volume Database

NCT00351598

Sponsor

Trans Tasman Radiation Oncology Group

Status

Completed

Last Update Posted

Aug 4, 2014Estimated

Enrollment

531Actual

Phase

Not provided

Conditions

Non-Small Cell Lung Cancer

Interventions

Definitive Radiotherapy

Countries

Australia
New Zealand
Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1999

Primary Completion Date

Feb 2009Actual

Completion Date

Nov 2012Actual

First Submitted Date

Jul 11, 2006

First Submission Date that Met QC Criteria

Jul 11, 2006

First Posted Date

Jul 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2014

Last Update Posted Date

Aug 4, 2014Estimated

Name	Class
Peter MacCallum Cancer Centre, Australia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

531Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients with loco-regional, NSCLC treated by definitive radiotherapy.	Radiation: Definitive Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Definitive Radiotherapy	Radiation	60Gy in 6 weeks, 50Gy in 4 weeks. Each individual fraction should not exceed 2.5Gy.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival	Survival duration defined as the time from date of registration until death from any cause	End of Study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with loco-regional non-small cell lung cancer

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
David Ball	Peter MacCallum Cancer Centre, Australia	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
St George Hospital		Kogarah	New South Wales	2217	Australia
Liverpool Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17409934	Result	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.

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms