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Rationale of technical requirements for NRG-BR001: The first NCI-sponsored trial of SBRT for the treatment of multiple metastases.

Publication ,  Journal Article
Al-Hallaq, HA; Chmura, S; Salama, JK; Winter, KA; Robinson, CG; Pisansky, TM; Borges, V; Lowenstein, JR; McNulty, S; Galvin, JM; Followill, DS ...
Published in: Pract Radiat Oncol
2016

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.

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Published In

Pract Radiat Oncol

DOI

EISSN

1879-8519

Publication Date

2016

Volume

6

Issue

6

Start / End Page

e291 / e298

Location

United States

Related Subject Headings

  • United States
  • Radiotherapy, Image-Guided
  • Radiotherapy Planning, Computer-Assisted
  • Radiotherapy Dosage
  • Radiosurgery
  • Prostatic Neoplasms
  • Neoplasm Metastasis
  • National Cancer Institute (U.S.)
  • Male
  • Lymphatic Metastasis
 

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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. Pract Radiat Oncol, 6(6), e291–e298. https://doi.org/10.1016/j.prro.2016.05.004
Al-Hallaq, Hania A., Steven Chmura, Joseph K. Salama, Kathryn A. Winter, Clifford G. Robinson, Thomas M. Pisansky, Virginia Borges, et al. “Rationale of technical requirements for NRG-BR001: The first NCI-sponsored trial of SBRT for the treatment of multiple metastases.Pract Radiat Oncol 6, no. 6 (2016): e291–98. https://doi.org/10.1016/j.prro.2016.05.004.
Al-Hallaq HA, Chmura S, Salama JK, Winter KA, Robinson CG, Pisansky TM, et al. Rationale of technical requirements for NRG-BR001: The first NCI-sponsored trial of SBRT for the treatment of multiple metastases. Pract Radiat Oncol. 2016;6(6):e291–8.
Al-Hallaq, Hania A., et al. “Rationale of technical requirements for NRG-BR001: The first NCI-sponsored trial of SBRT for the treatment of multiple metastases.Pract Radiat Oncol, vol. 6, no. 6, 2016, pp. e291–98. Pubmed, doi:10.1016/j.prro.2016.05.004.
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. Rationale of technical requirements for NRG-BR001: The first NCI-sponsored trial of SBRT for the treatment of multiple metastases. Pract Radiat Oncol. 2016;6(6):e291–e298.
Journal cover image

Published In

Pract Radiat Oncol

DOI

EISSN

1879-8519

Publication Date

2016

Volume

6

Issue

6

Start / End Page

e291 / e298

Location

United States

Related Subject Headings

  • United States
  • Radiotherapy, Image-Guided
  • Radiotherapy Planning, Computer-Assisted
  • Radiotherapy Dosage
  • Radiosurgery
  • Prostatic Neoplasms
  • Neoplasm Metastasis
  • National Cancer Institute (U.S.)
  • Male
  • Lymphatic Metastasis