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BMC Cancer
Published in: BMC Cancer 1/2012

Open Access 01-12-2012 | Study protocol

Stereotactic ablative radiotherapy for comprehensive treatment of oligometastatic tumors (SABR-COMET): Study protocol for a randomized phase II trial

Authors: David A Palma, Cornelis J A Haasbeek, George B Rodrigues, Max Dahele, Michael Lock, Brian Yaremko, Robert Olson, Mitchell Liu, Jason Panarotto, GwendolynHMJ Griffioen, Stewart Gaede, Ben Slotman, Suresh Senan

Published in: BMC Cancer | Issue 1/2012

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Abstract

Background

Stereotactic ablative radiotherapy (SABR) has emerged as a new treatment option for patients with oligometastatic disease. SABR delivers precise, high-dose, hypofractionated radiotherapy, and achieves excellent rates of local control. Survival outcomes for patients with oligometastatic disease treated with SABR appear promising, but conclusions are limited by patient selection, and the lack of adequate controls in most studies. The goal of this multicenter randomized phase II trial is to assess the impact of a comprehensive oligometastatic SABR treatment program on overall survival and quality of life in patients with up to 5 metastatic cancer lesions, compared to patients who receive standard of care treatment alone.

Methods

After stratification by the number of metastases (1-3 vs. 4-5), patients will be randomized between Arm 1: current standard of care treatment, and Arm 2: standard of care treatment + SABR to all sites of known disease. Patients will be randomized in a 1:2 ratio to Arm 1:Arm 2, respectively. For patients receiving SABR, radiotherapy dose and fractionation depends on the site of metastasis and the proximity to critical normal structures. This study aims to accrue a total of 99 patients within four years. The primary endpoint is overall survival, and secondary endpoints include quality of life, toxicity, progression-free survival, lesion control rate, and number of cycles of further chemotherapy/systemic therapy.

Discussion

This study will provide an assessment of the impact of SABR on clinical outcomes and quality of life, to determine if long-term survival can be achieved for selected patients with oligometastatic disease, and will inform the design of a possible phase III study.

Trial registration

Clinicaltrials.gov identifier: NCT01446744
Appendix
Available only for authorised users
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Metadata
Title
Stereotactic ablative radiotherapy for comprehensive treatment of oligometastatic tumors (SABR-COMET): Study protocol for a randomized phase II trial
Authors
David A Palma
Cornelis J A Haasbeek
George B Rodrigues
Max Dahele
Michael Lock
Brian Yaremko
Robert Olson
Mitchell Liu
Jason Panarotto
GwendolynHMJ Griffioen
Stewart Gaede
Ben Slotman
Suresh Senan
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2012
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-12-305

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