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

NCT ID: NCT01965223

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-04

Study Completion Date

2020-07-27

Brief Summary

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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

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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.

Conditions

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Cancer Metastases to the Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multi-fraction SABR

Radiotherapy: 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.

Group Type EXPERIMENTAL

Multi-fraction SABR

Intervention Type RADIATION

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

Single fraction SABR

Radiotherapy: 28Gy delivered in 1 fraction

Group Type EXPERIMENTAL

Single Fraction SABR

Intervention Type RADIATION

Single fraction SABR; 28Gy delivered in 1 fraction

Interventions

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Multi-fraction SABR

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

Intervention Type RADIATION

Single Fraction SABR

Single fraction SABR; 28Gy delivered in 1 fraction

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. A maximum of three metastases to the lung from any non-haematological malignancy
2. Tumour diameter ≤5cm
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Australasian Lung Cancer Trials Group

OTHER

Sponsor Role collaborator

Trans Tasman Radiation Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shankar Siva

Role: STUDY_CHAIR

Peter MacCallum Cancer Centre, Australia

Locations

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Liverpool Hospital

Liverpool, New South Wales, Australia

Site Status

Calvary Mater Hospital

Newcastle, New South Wales, Australia

Site Status

Prince of Wales Hospital

Randwick, New South Wales, Australia

Site Status

Northern Sydney Cancer Centre (RNS)

St Leonards, New South Wales, Australia

Site Status

Cambelltown Hospital

Sydney, New South Wales, Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Peter MacCallum Cancer Center

Melbourne, Victoria, Australia

Site Status

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status

Countries

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Australia

References

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Siva S, Sakyanun P, Mai T, Wong W, Lim A, Ludbrook J, Bettington C, Rezo A, Pryor D, Hardcastle N, Kron T, Higgs B, Le H, Skala M, Gill S, Eade T, Awad R, Sasso G, Vinod S, Montgomery R, Ball D, Bressel M. Long-Term Outcomes of TROG 13.01 SAFRON II Randomized Trial of Single- Versus Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases. J Clin Oncol. 2023 Jul 1;41(19):3493-3498. doi: 10.1200/JCO.23.00150. Epub 2023 May 14.

Reference Type DERIVED
PMID: 37179526 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34455431 (View on PubMed)

Other Identifiers

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TROG 13.01

Identifier Type: OTHER

Identifier Source: secondary_id

13001

Identifier Type: OTHER

Identifier Source: secondary_id

1111-1136-6607

Identifier Type: REGISTRY

Identifier Source: secondary_id

TROG 13.01

Identifier Type: -

Identifier Source: org_study_id