Data

TROG 13.01 SAFRON II Stereotactic ablative fractionated radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung: A randomised phase II trial

Trans Tasman Radiation Oncology Group (TROG Cancer Research)

Dataset description

Dataset Contains: Toxicity grade 3 or higher related to SABR treatment; Quality of life (EQ-5D and MDASI-LC); Time to local failure; Overall survival; Time to distant failure; Disease free survival; Resources use and costs associated with treatment (MBS/PBS data. Hospitalisations. QALYs); Imaging data (CT); Approx time period of data collection 2015-2021 Radiotherapy Quality Assurance 89 RTQA imaging datasets; 22 benchmarking datasets; RT plans, RT delivery and imaging documentation (DICOM format); LRF
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Subjects

Radiation Therapy |

Source Study

Purpose

Treatment

Phase

Phase 2

Funding

Government body,Cancer Australia

Scientific enquiries

A/Prof Shankar Siva

Brief Summary

This study is evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of lung tumours. Who is it for? You may be eligible to join this study if; + you are aged 18 years or above + have 1-3 lung metastases from any non-haematological primary tumour + you are medically inoperable, high risk or have decline surgery + you have not had any previous high-dose radiotheradpy to the chest region Study details: SABR is an exciting novel radiotherapy tech ....
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Key Inclusion Criteria

1) ECOG 0-1 inclusive 2) A maximum of three metastases to the lung from any non-haematological malignancy 3) Tumour diameter less than or equal to 5cm 4) Targets are located away from central structures (defined as 2cm beyond bifurcation of lobar bronchi and central airways). Targets in proximity to chest wall and mediastinum that meet these inclusion criteria are eligible. 5) Primary and extrathoracic disease controlled with local therapy (e.g. surgery/definitive radiotherapy) 6) Life expectanc ....
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Key Exclusion Criteria

1) Previous high-dose thoracic radiotherapy 2) Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. 3) Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment 4) Germ cell and small cell carcinoma histologies

Can healthy volunteers participate?

No

 

Population

Sample Size    90

Min. age    18 Years

Max. age    0 No limit

Sex    Both males and females

Condition category    Oligometastatic Neoplasia to the Lung (from any non-haematological malignancy)

Condition code    Cancer

Intervention

Intervention code Treatment: Devices

Multi-fraction Stereotactic Ablative Body Radiation (SABR); 48Gy delivered in 4 fractions over 2 weeks, with a minimum of 48 hours between each fraction.

Comparison

Control group Active

Single fraction SABR (also known as radiosurgery); 28Gy delivered in 1 fraction.

Outcomes

Outcome: The primary outcome is safety, defined as number of participants experiencing less than or equal to 5% toxicity at 12 months post treatment (toxicity measured by CTCAE V4).
Timepoint: 12 months post treatment

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au