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Trial registered on ANZCTR


Registration number
ACTRN12614000478617
Ethics application status
Approved
Date submitted
1/05/2014
Date registered
8/05/2014
Date last updated
4/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase II Study of Stereotactic Ablative Body Radiotherapy (SABR) for Stage I Non-Small Cell Lung Cancer (NSCLC)
Scientific title
Assessing the feasibility of Stereotactic Ablative Body Radiotherapy (SABR) for stage I Non-Small Cell Lung Cancer (NSCLC): A single arm prospective phase II non-randomized multicentre study
Secondary ID [1] 284508 0
Nil known
Universal Trial Number (UTN)
U1111-1156-1927
Trial acronym
SABR Lung
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small cell lung cancer, stage T1-T2, N0M0 (AJCC staging, 6th ed.) 291768 0
Condition category
Condition code
Cancer 292126 292126 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stereotactic ablative body radiotherapy
Patients will be assigned to 1 of 3 treatment arms, dependent on site of the lesion.
1. Peripheral lesions:
- Tumour GTV less than 1.5 cm from ribs: 48 Gy in 4 fractions (12Gy/#)
- Tumour GTV greater than or equal to1.5 cm from ribs: 54 Gy in 3 fractions (18Gy/#)
2. Central lesions:
- 50 Gy in 5 fractions (10Gy/#)

Two to three treatments are to be delivered per week. There must be a minimum break of 1 day and a maximum break of 4 days between fractions. The following applied to the treatment delivery times:
3 fraction regimens to be delivered within 11 days
4 fraction regimens to be delivered within 14 days
5 fraction regimens to be delivered within 14 days
Intervention code [1] 289266 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292005 0
Local control
The primary lung tumour (target lesion) is measured by CT scans and evaluated using the Revised Response Evaluation Criteria in Solid Tumours (RECIST) Guideline version1.1. Local control consists of Complete Response or Partial Response or Stable Disease and will be correspond to the absence of Local Failure.
Timepoint [1] 292005 0
baseline, 4 weeks post-treatment, then 3 montly until 24 months
Secondary outcome [1] 307990 0
Achievement of dosimetric constraints
Dosimetry assessment is based on the dose information reported according to the requirements of International Commission on Radiation Units and Measurements (ICRU83). Doses to central organs at risk and all the conformity indices parameters are also recorded.
Timepoint [1] 307990 0
collected from the treatment planning data
Secondary outcome [2] 307991 0
Overall survival measured from the date of enrolment to death from any cause. Assessed via clinical assessment and ongoing follow-up.
Timepoint [2] 307991 0
4 weeks post treatment, then 3 monthly until 24 months and then 6 monthly until 60 months
Secondary outcome [3] 307992 0
Progression free survival-defined as the absence of local failure and/or regional failure and/or distant failure and/or death from any cause. Assessed via clinical asssessment and ongoing follow-up.
Timepoint [3] 307992 0
4 weeks post treatment, then 3 monthly until 24 months and then 6 monthly until 60 months
Secondary outcome [4] 307993 0
Loco-regional control
Assessment of loco-regional control is made by evaluation of non-target lesions, which is recorded at the point of their appearance and throughout follow-up. Assessed via CT scans.
Timepoint [4] 307993 0
3 monthly until 24 months and then 6 monthly until 60 months
Secondary outcome [5] 307994 0
Distant metastases
Metastatic progression is made in comparison to the required pretreatment staging studies or any other pretreatment imaging evaluations available. Assessed via CT scans.
Timepoint [5] 307994 0
3 monthly until 24 months and then 6 monthly until 60 months
Secondary outcome [6] 307995 0
Lung function
Lung function is assessed by lung function test which is performed once every 6 months.
Timepoint [6] 307995 0
6 monthly until 60 months
Secondary outcome [7] 307996 0
Quality of life outcomes
Measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer 30 (EORTC QLQ-C30) and Lung Cancer (LC-13)
Timepoint [7] 307996 0
4 weeks post treatment, then 3 monthly until 24 months and then 6 monthly until 60 months
Secondary outcome [8] 307997 0
Ability to deliver treatment with the development of no Grade 3 or greater CTCAE version 4.0 toxicity. Assessment made by clinical assessment and ongoing follow up.
Timepoint [8] 307997 0
4 weeks post treatment, then 3 monthly until 24 months and then 6 monthly until 60 months

Eligibility
Key inclusion criteria
Diagnosis of non-small cell lung cancer
-Pathological diagnosis is desirable where this can be achieved.
-Diagnosis based on imaging: requires evidence that lesion(s) are increasing in size on 2 consecutive CT scans and /or increased uptake on PET.

Stage T1-T2, N0M0 (AJCC Staging, 6th ed.) with tumour size less than or equal to 5 cm, based upon:
-History and physical examination 4 weeks prior to registration.
-CT chest, abdomen and pelvis and/or
-FDG PET-CT scan

ECOG performance status of less than or equal to 2

Patients must be able to lie flat and comply with the requirements of simulation and treatment.

Patients with previous thoracic radiotherapy are permitted, provided V20 less than 15% on previous treatment an no overlap with intended current radiotherapy field

Patients with previous history of malignancy may be included provided the previous malignancy is in remission and after a MDT discussion the current lung lesion is thought to be more likely of lung primary rather than metastatic disease
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women

Inability to lie flat and tolerate immobilization for duration of planning and treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary end point, local control at 24 months from start of treatment, is used for sample size calculation. Prior data indicate that the probability of local recurrence amongst cases receiving the historical standard treatment (3D-Conformal radiotherapy from 60 to 70 Gy) is 0.65. This estimate of local control from historical techniques is conservatively high, and other studies have shown local control rates under 50%. A sample size of 85 will allow the detection of a 15% difference in local control rates to 65% from those of historical data (50%), with a significance level of 5% and power of 80%. Allowing for an approximate 15% drop-out rate for follow-up, we will recruit approximately 100 patients. Based on estimated recruitment form centres currently treating SABR lung cancer, this sample size should be easily achievable. STATA SE version 11 was used for sample size calculation (one sample). Proportions for local control at 24 months will be described as percentage with 95% CI.

Analysis for secondary endpoints will be descriptive.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2372 0
St George Hospital - Kogarah
Recruitment hospital [2] 2373 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 2374 0
Westmead Hospital - Westmead
Recruitment hospital [4] 2375 0
Gosford Hospital - Gosford
Recruitment hospital [5] 2376 0
Lismore Base Hospital - Lismore
Recruitment hospital [6] 2377 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [7] 2378 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [8] 2379 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [9] 2380 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [10] 2381 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [11] 2382 0
Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors
Funding source category [1] 289151 0
Self funded/Unfunded
Name [1] 289151 0
Address [1] 289151 0
Country [1] 289151 0
Primary sponsor type
Individual
Name
Dr Eric Hau
Address
Cancer Care Centre
St George Hospital
Gray Street, Kogarah, NSW 2217
Country
Australia
Secondary sponsor category [1] 287823 0
None
Name [1] 287823 0
Address [1] 287823 0
Country [1] 287823 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290927 0
South Eastern Sydney Local Health District
Ethics committee address [1] 290927 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick, NSW, 2031
Ethics committee country [1] 290927 0
Australia
Date submitted for ethics approval [1] 290927 0
Approval date [1] 290927 0
09/12/2013
Ethics approval number [1] 290927 0
13/240 (HREC/13/POWH/781)
Ethics committee name [2] 290928 0
Cancer Institute NSW
Ethics committee address [2] 290928 0
Level 9, 8 Central Avenue, Australian Technology Park, Eveleigh, NSW 2015
Ethics committee country [2] 290928 0
Australia
Date submitted for ethics approval [2] 290928 0
Approval date [2] 290928 0
09/12/2011
Ethics approval number [2] 290928 0
HREC/11/CIC/22 (2011C/09/170)

Summary
Brief summary
This study aims to investigate the efficacy of stereotactic ablative radiation therapy for treatment of Stage I non-small cell lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of Stage I non-small cell lung cancer. You must be able to lie flat and comply with the requirements of simulation and treatment. Participants in this study will be treated with stereotactic ablative radiation therapy with one of three dose and fractionation regimens. For peripheral lesions treatment dose will be 48 Gy in 4 fractions or 54 Gy in 3 fractions, depending on tumour size. For central lesions 50 Gy will be administered in 5 fractions. Overall treatment duration will vary from 11 – 14 days. Local control at 24 months is the primary endpoint of the study and is assessed by CT scans. Patients will be followed up until 5 years post treatment. A total of 100 patients will be recruited in this study.
Trial website
Trial related presentations / publications
Conference presentations:

Collaborative implementation of stereotactic ablative body radiotherapy. A model for the safe implementation of complex radiotherapy techniques in Australia. Hau E, Hegi-Johnson F, ,Barber J, Best S, Browne L, Chin Y, Downes S, Dwyer P, Eade T, Graham PH, Lu D, Rains M, Small K, Unicomb K, West K, White S, Wong W, van Tilburg K, Yeghiaian-Alvandi R. 2014 Annual Scientific Meeting, Melbourne Australia

I Love a Sunburnt Country...Tripartite Collaborative Approaches to Bring Stereotactic Ablative Radiotherapy (SABR) Lung to the People of Regional Australia. Fiona Hegi-Johnson, Eric Hau, Kylie Unicomb, Jeff Barber, Melissa Rains,Dan Lu, Michael Bailey, Matthew Foote, Roland Yeghiaian-Alvandi. 15th World Conference on Lung Cancer,
October 2013, Sydney Australia
Public notes

Contacts
Principal investigator
Name 47998 0
Dr Eric Hau
Address 47998 0
Cancer Care Centre
St George Hospital
Gray Street, Kogarah, NSW, 2217
Country 47998 0
Australia
Phone 47998 0
+61 2 9113 3835
Fax 47998 0
Email 47998 0
Eric.Hau@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 47999 0
Ms Dan Lu
Address 47999 0
Clinical Research Unit
Pitney Clinical Sciences Building
St George Hospital
Gray Street, Kogarah, NSW, 2217
Country 47999 0
Australia
Phone 47999 0
+61 2 9113 4825
Fax 47999 0
+61 2 9113 4822
Email 47999 0
Dan.Lu@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 48000 0
Dr Fiona Hegi-Johnson
Address 48000 0
Central Coast Cancer Centre
Gosford Hospital
Holden Street, Gosford, NSW, 2250
Country 48000 0
Australia
Phone 48000 0
+61 2 4320 9811
Fax 48000 0
Email 48000 0
Fiona.Hegi-Johnson@health.nsw.gov.au or fionahegi@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results