Non-Small Cell Lung CancerNCT00351598
Lung Tumour Volume Database
An observational study of Non-Small Cell Lung Cancer, run by Trans Tasman Radiation Oncology Group at 15 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Definitive Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 531 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Sep 1999to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with loco-regional non-small cell lung cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
Australia13 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
Austin Health
Heidelberg, Victoria, 3081
St George Hospital
Kogarah, New South Wales, 2217
Liverpool Hospital
Liverpool, New South Wales, 1871
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, 2298
Alfred Hospital
Prahran, Victoria, 3181
Mater QRI
South Brisbane, Queensland, 4101
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
East Coast Cancer Centre
Tugun, Queensland, 4224
Westmead Hospital
Wentworthville, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
Official title: Tumour Volume as an Independent Prognostic Factor in Patients With Non-Small Cell Lung Cancer - A Protocol for a Prospective Database.
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).
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Definitive Radiotherapy
- Keywords
- Tumour Volume, Prognostic value
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definitive RadiotherapyRadiation
Also called Radiation
60Gy in 6 weeks, 50Gy in 4 weeks. Each individual fraction should not exceed 2.5Gy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with loco-regional, NSCLC treated by definitive radiotherapy. Receives: Radiation: Definitive Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival duration defined as the time from date of registration until death from any cause
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startSep 1999
- Primary completionFeb 2009
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Peter MacCallum Cancer Centre, Australia
- Responsible party
- Sponsor
- Investigators
- David Ball, Study chair, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351598
- Sponsor's protocol ID
- TROG 99.05
- Status last verified
- Jul 2014
- First submitted
- 11 Jul 2006
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17409934
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumour Volume as an Independent Prognostic Factor in Patients With Non-Small Cell Lung Cancer - A Protocol for a Prospective Database.
- ClinicalTrials.gov ID
- NCT00351598
- Acronym / sponsor ID
- TROG 99.05
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Tumour Volume, Prognostic value
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Collaborators
- Peter MacCallum Cancer Centre, Australia
- Study start
- Sep 1999
- Primary completion
- Feb 2009 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Radiation: Definitive RadiotherapyPatients with loco-regional, NSCLC treated by definitive radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with loco-regional non-small cell lung cancer
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Definitive RadiotherapyAlso: Radiation60Gy in 6 weeks, 50Gy in 4 weeks. Each individual fraction should not exceed 2.5Gy. | Radiation | 1 |
Primary outcome
Survival
Time frame: End of Study
Survival duration defined as the time from date of registration until death from any cause
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
- Results publication: PubMed 17409934Ball 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.
- Click here for more information about this study on the TROG official websiteLink provided by the sponsor.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 3
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Non-small Cell Lung Cancer, NSCLC
RecruitingPhase 3
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma
RecruitingPhase 3
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1
Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib
Lung Cancer
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
Non-small Cell Lung Cancer (NSCLC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ball study chair
Peter MacCallum Cancer Centre, Australia
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Trans Tasman Radiation Oncology Group at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Australia, New Zealand, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: End of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00351598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2014.