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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

Tracking Information
First Submitted Date  ICMJE October 13, 2013
First Posted Date  ICMJE October 18, 2013
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE February 4, 2015
Actual Primary Completion Date July 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2015)
  • Quality of Life [ Time Frame: 24 months ]
    To compare quality of life outcomes between techniques assessed using EQ-5DL and MDASI-LC questionnaires.
  • Time to local failure [ Time Frame: 24 months ]
    Local progression free survival assesed by CT scan and clinical assessment
  • Overall survival [ Time Frame: 24 months ]
    Overall survival assesed by clinical assessment
  • Time to distant failure [ Time Frame: 24 months ]
    Time to distant failure assessed by CT scan and clinical assessment
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2013)
  • Quality of Life [ Time Frame: 24 months ]
    To compare quality of life outcomes between techniques assessed using EQ-5DL and MDASI-LC questionnaires.
  • Local progression free survival [ Time Frame: 24 months ]
    Local progression free survival assesed by CT scan and clinical assessment
  • Overall survival [ Time Frame: 24 months ]
    Overall survival assesed by clinical assessment
  • Time to distant failure [ Time Frame: 24 months ]
    Time to distant failure assessed by CT scan and clinical assessment
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: October 15, 2013)
Immune response [ Time Frame: 3 months ]
To explore immune system responses to single fraction and multi-fraction SABR.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Randomized Phase II Study of Stereotactic Ablative Body Radiotherapy for Metastases to the Lung (TROG 13.01 SAFRON II)
Official Title  ICMJE Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Metastases to the Lung
Intervention  ICMJE
  • Radiation: Multi-fraction SABR
    Multi-fraction SABR; 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.
  • Radiation: Single Fraction SABR
    Single fraction SABR; 28Gy delivered in 1 fraction
Study Arms  ICMJE
  • Experimental: Multi-fraction SABR
    Radiotherapy: 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.
    Intervention: Radiation: Multi-fraction SABR
  • Experimental: Single fraction SABR
    Radiotherapy: 28Gy delivered in 1 fraction
    Intervention: Radiation: Single Fraction SABR
Publications * Siva S, Bressel M, Mai T, Le H, Vinod S, de Silva H, Macdonald S, Skala M, Hardcastle N, Rezo A, Pryor D, Gill S, Higgs B, Wagenfuehr K, Montgomery R, Awad R, Chesson B, Eade T, Wong W, Sasso G, De Abreu Lourenco R, Kron T, Ball D, Neeson P; Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung (SAFRON) II Study Investigators. Single-Fraction vs Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases (SAFRON II): The Trans Tasman Radiation Oncology Group 13.01 Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1476-1485. doi: 10.1001/jamaoncol.2021.2939.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2018)
90
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2013)
84
Actual Study Completion Date  ICMJE July 27, 2020
Actual Primary Completion Date July 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01965223
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Trans Tasman Radiation Oncology Group
Study Sponsor  ICMJE Trans Tasman Radiation Oncology Group
Collaborators  ICMJE Australasian Lung Cancer Trials Group
Investigators  ICMJE
Study Chair: Shankar Siva Peter MacCallum Cancer Centre, Australia
PRS Account Trans Tasman Radiation Oncology Group
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP