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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01965223
Recruitment Status : Completed
First Posted : October 18, 2013
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Australasian Lung Cancer Trials Group
Information provided by (Responsible Party):
Trans Tasman Radiation Oncology Group

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Metastases to the Lung Radiation: Multi-fraction SABR Radiation: Single Fraction SABR Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial
Actual Study Start Date : February 4, 2015
Actual Primary Completion Date : July 27, 2020
Actual Study Completion Date : July 27, 2020

Arm Intervention/treatment
Experimental: Multi-fraction SABR
Radiotherapy: 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.
Radiation: Multi-fraction SABR
Multi-fraction SABR; 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.

Experimental: Single fraction SABR
Radiotherapy: 28Gy delivered in 1 fraction
Radiation: Single Fraction SABR
Single fraction SABR; 28Gy delivered in 1 fraction




Primary Outcome Measures :
  1. Toxicity [ Time Frame: 12 months ]
    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).


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 24 months ]
    To compare quality of life outcomes between techniques assessed using EQ-5DL and MDASI-LC questionnaires.

  2. Time to local failure [ Time Frame: 24 months ]
    Local progression free survival assesed by CT scan and clinical assessment

  3. Overall survival [ Time Frame: 24 months ]
    Overall survival assesed by clinical assessment

  4. Time to distant failure [ Time Frame: 24 months ]
    Time to distant failure assessed by CT scan and clinical assessment

  5. Resources use and costs associated with treatment [ Time Frame: 24 months ]
    Resources use and costs associated with treatment assessed by EQ5DL and accessing Medicare data

  6. Disease Free Survival [ Time Frame: 24 months ]
    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.


Other Outcome Measures:
  1. Immune response [ Time Frame: 3 months ]
    To explore immune system responses to single fraction and multi-fraction SABR.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965223


Locations
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Australia, New South Wales
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Calvary Mater Hospital
Newcastle, New South Wales, Australia, 2298
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Northern Sydney Cancer Centre (RNS)
St Leonards, New South Wales, Australia, 2065
Cambelltown Hospital
Sydney, New South Wales, Australia, 2560
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Trans Tasman Radiation Oncology Group
Australasian Lung Cancer Trials Group
Investigators
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Study Chair: Shankar Siva Peter MacCallum Cancer Centre, Australia
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Responsible Party: Trans Tasman Radiation Oncology Group
ClinicalTrials.gov Identifier: NCT01965223    
Other Study ID Numbers: TROG 13.01
TROG 13.01 ( Other Identifier: Trans Tasman Radiation Oncology Group )
13001 ( Other Identifier: Australasian Lung Trials Group )
1111-1136-6607 ( Registry Identifier: WHO )
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Keywords provided by Trans Tasman Radiation Oncology Group:
Oligometastatic
Neoplasia
Radiosurgery
Stereotactic Ablative Body Radiotherapy
SABR
Metastases to the Lung
Non Haematological
Additional relevant MeSH terms:
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Neoplasm Metastasis
Lung Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases