Rationale of technical requirements for NRG-BR001

The first NCI-sponsored trial of SBRT for the treatment of multiple metastases

Hania A. Al-Hallaq, Steven Chmura, Joseph K. Salama, Kathryn A. Winter, Clifford G. Robinson, Thomas M. Pisansky, Virginia Borges, Jessica R. Lowenstein, Susan McNulty, James M. Galvin, David S. Followill, Robert D. Timmerman, Julia R. White, Ying Xiao, Martha M. Matuszak

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Introduction In 2014, the NRG Oncology Group initiated the first National Cancer Institute-sponsored, phase 1 clinical trial of stereotactic body radiation therapy (SBRT) for the treatment of multiple metastases in multiple organ sites (BR001; NCT02206334). The primary endpoint is to test the safety of SBRT for the treatment of 2 to 4 multiple lesions in several anatomic sites in a multi-institutional setting. Because of the technical challenges inherent to treating multiple lesions as their spatial separation decreases, we present the technical requirements for NRG-BR001 and the rationale for their selection. Methods and materials Patients with controlled primary tumors of breast, non-small cell lung, or prostate are eligible if they have 2 to 4 metastases distributed among 7 extracranial anatomic locations throughout the body. Prescription and organ-at-risk doses were determined by expert consensus. Credentialing requirements include (1) irradiation of the Imaging and Radiation Oncology Core phantom with SBRT, (2) submitting image guided radiation therapy case studies, and (3) planning the benchmark. Guidelines for navigating challenging planning cases including assessing composite dose are discussed. Results Dosimetric planning to multiple lesions receiving differing doses (45-50 Gy) and fractionation (3-5) while irradiating the same organs at risk is discussed, particularly for metastases in close proximity (≤ 5 cm). The benchmark case was selected to demonstrate the planning tradeoffs required to satisfy protocol requirements for 2 nearby lesions. Examples of passing benchmark plans exhibited a large variability in plan conformity. Discussion NRG-BR001 was developed using expert consensus on multiple issues from the dose fractionation regimen to the minimum image guided radiation therapy guidelines. Credentialing was tied to the task rather than the anatomic site to reduce its burden. Every effort was made to include a variety of delivery methods to reflect current SBRT technology. Although some simplifications were adopted, the successful completion of this trial will inform future designs of both national and institutional trials and would allow immediate clinical adoption of SBRT trials for oligometastases.

Original languageEnglish (US)
Pages (from-to)e291-e298
JournalPractical Radiation Oncology
Volume6
Issue number6
DOIs
StatePublished - Nov 1 2016

Fingerprint

Radiotherapy
Benchmarking
Neoplasm Metastasis
Image-Guided Radiotherapy
Credentialing
Organs at Risk
Guidelines
Dose Fractionation
Therapeutics
Clinical Trials, Phase I
Radiation Oncology
National Cancer Institute (U.S.)
Prescriptions
Prostate
Breast Neoplasms
Technology
Safety
Lung

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging

Cite this

Al-Hallaq, H. A., Chmura, S., Salama, J. K., Winter, K. A., Robinson, C. G., Pisansky, T. M., ... Matuszak, M. M. (2016). Rationale of technical requirements for NRG-BR001: The first NCI-sponsored trial of SBRT for the treatment of multiple metastases. Practical Radiation Oncology, 6(6), e291-e298. https://doi.org/10.1016/j.prro.2016.05.004

Rationale of technical requirements for NRG-BR001 : The first NCI-sponsored trial of SBRT for the treatment of multiple metastases. / Al-Hallaq, Hania A.; Chmura, Steven; Salama, Joseph K.; Winter, Kathryn A.; Robinson, Clifford G.; Pisansky, Thomas M.; Borges, Virginia; Lowenstein, Jessica R.; McNulty, Susan; Galvin, James M.; Followill, David S.; Timmerman, Robert D.; White, Julia R.; Xiao, Ying; Matuszak, Martha M.

In: Practical Radiation Oncology, Vol. 6, No. 6, 01.11.2016, p. e291-e298.

Research output: Contribution to journalArticle

Al-Hallaq, HA, Chmura, S, Salama, JK, Winter, KA, Robinson, CG, Pisansky, TM, Borges, V, Lowenstein, JR, McNulty, S, Galvin, JM, Followill, DS, Timmerman, RD, White, JR, Xiao, Y & Matuszak, MM 2016, 'Rationale of technical requirements for NRG-BR001: The first NCI-sponsored trial of SBRT for the treatment of multiple metastases', Practical Radiation Oncology, vol. 6, no. 6, pp. e291-e298. https://doi.org/10.1016/j.prro.2016.05.004
Al-Hallaq, Hania A. ; Chmura, Steven ; Salama, Joseph K. ; Winter, Kathryn A. ; Robinson, Clifford G. ; Pisansky, Thomas M. ; Borges, Virginia ; Lowenstein, Jessica R. ; McNulty, Susan ; Galvin, James M. ; Followill, David S. ; Timmerman, Robert D. ; White, Julia R. ; Xiao, Ying ; Matuszak, Martha M. / Rationale of technical requirements for NRG-BR001 : The first NCI-sponsored trial of SBRT for the treatment of multiple metastases. In: Practical Radiation Oncology. 2016 ; Vol. 6, No. 6. pp. e291-e298.
@article{c3c47bb17ae442248a4cb1a746a23017,
title = "Rationale of technical requirements for NRG-BR001: The first NCI-sponsored trial of SBRT for the treatment of multiple metastases",
abstract = "Introduction In 2014, the NRG Oncology Group initiated the first National Cancer Institute-sponsored, phase 1 clinical trial of stereotactic body radiation therapy (SBRT) for the treatment of multiple metastases in multiple organ sites (BR001; NCT02206334). The primary endpoint is to test the safety of SBRT for the treatment of 2 to 4 multiple lesions in several anatomic sites in a multi-institutional setting. Because of the technical challenges inherent to treating multiple lesions as their spatial separation decreases, we present the technical requirements for NRG-BR001 and the rationale for their selection. Methods and materials Patients with controlled primary tumors of breast, non-small cell lung, or prostate are eligible if they have 2 to 4 metastases distributed among 7 extracranial anatomic locations throughout the body. Prescription and organ-at-risk doses were determined by expert consensus. Credentialing requirements include (1) irradiation of the Imaging and Radiation Oncology Core phantom with SBRT, (2) submitting image guided radiation therapy case studies, and (3) planning the benchmark. Guidelines for navigating challenging planning cases including assessing composite dose are discussed. Results Dosimetric planning to multiple lesions receiving differing doses (45-50 Gy) and fractionation (3-5) while irradiating the same organs at risk is discussed, particularly for metastases in close proximity (≤ 5 cm). The benchmark case was selected to demonstrate the planning tradeoffs required to satisfy protocol requirements for 2 nearby lesions. Examples of passing benchmark plans exhibited a large variability in plan conformity. Discussion NRG-BR001 was developed using expert consensus on multiple issues from the dose fractionation regimen to the minimum image guided radiation therapy guidelines. Credentialing was tied to the task rather than the anatomic site to reduce its burden. Every effort was made to include a variety of delivery methods to reflect current SBRT technology. Although some simplifications were adopted, the successful completion of this trial will inform future designs of both national and institutional trials and would allow immediate clinical adoption of SBRT trials for oligometastases.",
author = "Al-Hallaq, {Hania A.} and Steven Chmura and Salama, {Joseph K.} and Winter, {Kathryn A.} and Robinson, {Clifford G.} and Pisansky, {Thomas M.} and Virginia Borges and Lowenstein, {Jessica R.} and Susan McNulty and Galvin, {James M.} and Followill, {David S.} and Timmerman, {Robert D.} and White, {Julia R.} and Ying Xiao and Matuszak, {Martha M.}",
year = "2016",
month = "11",
day = "1",
doi = "10.1016/j.prro.2016.05.004",
language = "English (US)",
volume = "6",
pages = "e291--e298",
journal = "Practical Radiation Oncology",
issn = "1879-8500",
publisher = "Elsevier BV",
number = "6",

}

TY - JOUR

T1 - Rationale of technical requirements for NRG-BR001

T2 - The first NCI-sponsored trial of SBRT for the treatment of multiple metastases

AU - Al-Hallaq, Hania A.

AU - Chmura, Steven

AU - Salama, Joseph K.

AU - Winter, Kathryn A.

AU - Robinson, Clifford G.

AU - Pisansky, Thomas M.

AU - Borges, Virginia

AU - Lowenstein, Jessica R.

AU - McNulty, Susan

AU - Galvin, James M.

AU - Followill, David S.

AU - Timmerman, Robert D.

AU - White, Julia R.

AU - Xiao, Ying

AU - Matuszak, Martha M.

PY - 2016/11/1

Y1 - 2016/11/1

N2 - Introduction In 2014, the NRG Oncology Group initiated the first National Cancer Institute-sponsored, phase 1 clinical trial of stereotactic body radiation therapy (SBRT) for the treatment of multiple metastases in multiple organ sites (BR001; NCT02206334). The primary endpoint is to test the safety of SBRT for the treatment of 2 to 4 multiple lesions in several anatomic sites in a multi-institutional setting. Because of the technical challenges inherent to treating multiple lesions as their spatial separation decreases, we present the technical requirements for NRG-BR001 and the rationale for their selection. Methods and materials Patients with controlled primary tumors of breast, non-small cell lung, or prostate are eligible if they have 2 to 4 metastases distributed among 7 extracranial anatomic locations throughout the body. Prescription and organ-at-risk doses were determined by expert consensus. Credentialing requirements include (1) irradiation of the Imaging and Radiation Oncology Core phantom with SBRT, (2) submitting image guided radiation therapy case studies, and (3) planning the benchmark. Guidelines for navigating challenging planning cases including assessing composite dose are discussed. Results Dosimetric planning to multiple lesions receiving differing doses (45-50 Gy) and fractionation (3-5) while irradiating the same organs at risk is discussed, particularly for metastases in close proximity (≤ 5 cm). The benchmark case was selected to demonstrate the planning tradeoffs required to satisfy protocol requirements for 2 nearby lesions. Examples of passing benchmark plans exhibited a large variability in plan conformity. Discussion NRG-BR001 was developed using expert consensus on multiple issues from the dose fractionation regimen to the minimum image guided radiation therapy guidelines. Credentialing was tied to the task rather than the anatomic site to reduce its burden. Every effort was made to include a variety of delivery methods to reflect current SBRT technology. Although some simplifications were adopted, the successful completion of this trial will inform future designs of both national and institutional trials and would allow immediate clinical adoption of SBRT trials for oligometastases.

AB - Introduction In 2014, the NRG Oncology Group initiated the first National Cancer Institute-sponsored, phase 1 clinical trial of stereotactic body radiation therapy (SBRT) for the treatment of multiple metastases in multiple organ sites (BR001; NCT02206334). The primary endpoint is to test the safety of SBRT for the treatment of 2 to 4 multiple lesions in several anatomic sites in a multi-institutional setting. Because of the technical challenges inherent to treating multiple lesions as their spatial separation decreases, we present the technical requirements for NRG-BR001 and the rationale for their selection. Methods and materials Patients with controlled primary tumors of breast, non-small cell lung, or prostate are eligible if they have 2 to 4 metastases distributed among 7 extracranial anatomic locations throughout the body. Prescription and organ-at-risk doses were determined by expert consensus. Credentialing requirements include (1) irradiation of the Imaging and Radiation Oncology Core phantom with SBRT, (2) submitting image guided radiation therapy case studies, and (3) planning the benchmark. Guidelines for navigating challenging planning cases including assessing composite dose are discussed. Results Dosimetric planning to multiple lesions receiving differing doses (45-50 Gy) and fractionation (3-5) while irradiating the same organs at risk is discussed, particularly for metastases in close proximity (≤ 5 cm). The benchmark case was selected to demonstrate the planning tradeoffs required to satisfy protocol requirements for 2 nearby lesions. Examples of passing benchmark plans exhibited a large variability in plan conformity. Discussion NRG-BR001 was developed using expert consensus on multiple issues from the dose fractionation regimen to the minimum image guided radiation therapy guidelines. Credentialing was tied to the task rather than the anatomic site to reduce its burden. Every effort was made to include a variety of delivery methods to reflect current SBRT technology. Although some simplifications were adopted, the successful completion of this trial will inform future designs of both national and institutional trials and would allow immediate clinical adoption of SBRT trials for oligometastases.

UR - http://www.scopus.com/inward/record.url?scp=84995686976&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84995686976&partnerID=8YFLogxK

U2 - 10.1016/j.prro.2016.05.004

DO - 10.1016/j.prro.2016.05.004

M3 - Article

VL - 6

SP - e291-e298

JO - Practical Radiation Oncology

JF - Practical Radiation Oncology

SN - 1879-8500

IS - 6

ER -