A Randomized Phase II Study of Stereotactic Ablative Body Radiotherapy for Metastases to the Lung (TROG 13.01 SAFRON II)

Cancer Clinical Trial

— SAFRON II  

Official title:

Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965223
• Other study ID #: TROG 13.01
• Secondary ID: TROG 13.01130011
• Status: Completed
• Phase: N/A
• Start date: February 4, 2015
• Est. completion date: July 27, 2020

Study information

• Verified date: November 2020
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to determine the safety (defined as number of participants experiencing ≥ 5% toxicity at 12 months post treatment) of stereotactic ablative fractionated radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung.

Description:

Stereotactic Ablative Body Radiotherapy (SABR) is an exciting novel radiotherapy technique that is delivered over very few sessions. In the case of limited pulmonary 'oligometastases', SABR can result in long-term survival. It is non-invasive and associated with high rates of tumour control and relatively low toxicity. Additionally, the large doses of precision radiotherapy involved may evoke a strong immune response to recognise and attack any remaining tumour cells. In the future, SABR may be an attractive alternative to invasive surgery. There are two SABR techniques emerging in Australia; fractionated and single fraction treatments. We aim to conduct the first clinical trial of SABR in patients with limited pulmonary metastases testing fractionated versus single fraction treatments.

The primary aim of this study is to evaluate the toxicity, Quality of Life, clinical efficacy and cost effectiveness of single fraction SABR compared to multi-fraction SABR in patients with oligometastases to the lung.

The secondary aim of this study is to assess the immune response evoked by both fractionated and single fraction SABR and its prognostic implications for patient outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 27, 2020
• Est. primary completion date: July 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. A maximum of three metastases to the lung from any non-haematological malignancy

2. Tumour diameter =5cm

3. 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.

4. Patients must be medically inoperable, technically high risk or have declined surgery.

Exclusion Criteria:

1. Previous high-dose thoracic radiotherapy.

2. Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are not excluded (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotrophin releasing hormone receptor modulators)

3. Targeted agents (such as sunitinib and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.

Related Conditions & MeSH terms

• Cancer
• Lung Neoplasms
• Metastases to the Lung
• Neoplasm Metastasis

Intervention

Radiation:
• Multi-fraction SABR
Multi-fraction SABR; 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.
• Single Fraction SABR
Single fraction SABR; 28Gy delivered in 1 fraction

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Peter MacCallum Cancer Center	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Calvary Mater Hospital	Newcastle	New South Wales
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Northern Sydney Cancer Centre (RNS)	St Leonards	New South Wales
Australia	Cambelltown Hospital	Sydney	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Trans-Tasman Radiation Oncology Group (TROG)	Australasian Lung Cancer Trials Group

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immune response	To explore immune system responses to single fraction and multi-fraction SABR.	3 months
Primary	Toxicity	The primary outcome is safety, defined as number of participants experiencing less than or equal to 5% toxicity at 12 months post treatment (toxicity as measured by CTCAE V4).	12 months
Secondary	Quality of Life	To compare quality of life outcomes between techniques assessed using EQ-5DL and MDASI-LC questionnaires.	24 months
Secondary	Time to local failure	Local progression free survival assesed by CT scan and clinical assessment	24 months
Secondary	Overall survival	Overall survival assesed by clinical assessment	24 months
Secondary	Time to distant failure	Time to distant failure assessed by CT scan and clinical assessment	24 months
Secondary	Resources use and costs associated with treatment	Resources use and costs associated with treatment assessed by EQ5DL and accessing Medicare data	24 months
Secondary	Disease Free Survival	Disease free survival will be measured from the date of randomisation to the date of a local recurrence, regional or distant metastasis, or death from any cause, whichever occurs first.	24 months