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NCT Number: NCT01965223

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

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.

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Key information

Conditions

Cancer Metastases to the Lung Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool Hospital, Liverpool, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A maximum of three metastases to the lung from any non-haematological malignancy
  • Tumour diameter ≤5cm
  • 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.
  • Patients must be medically inoperable, technically high risk or have declined surgery.

Exclusion criteria

  • Previous high-dose thoracic radiotherapy.
  • 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)
  • Targeted agents (such as sunitinib and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.

Treatment and study plan

Multi-fraction SABR

Radiation

Multi-fraction SABR; 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.

Single Fraction SABR

Radiation

Single fraction SABR; 28Gy delivered in 1 fraction

Primary outcomes

  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 outcomes

  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 outcomes

  1. Immune response

    Time frame: 3 months

    To explore immune system responses to single fraction and multi-fraction SABR.

Sponsors and collaborators

Lead sponsor

Trans Tasman Radiation Oncology Group

Other

Collaborators

  • Australasian Lung Cancer Trials Group

Registry information

Official study title

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

Acronym: SAFRON II

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 18, 2013
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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