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A phase II multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases
BACKGROUND: Our research group has previously published a dosimetric planning study that demonstrated that a 60 Gy/10 fractions intralesional boost with whole-brain radiotherapy (WBRT) to 30 Gy/10 fractions was biologically equivalent with a stereotactic radiosurgery (SRS) boost of 18 Gy/1 fraction...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3341183/ https://www.ncbi.nlm.nih.gov/pubmed/22436144 http://dx.doi.org/10.1186/1748-717X-7-42 |
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author | Rodrigues, George Yartsev, Slav Tay, Keng Yeow Pond, Gregory R Lagerwaard, Frank Bauman, Glenn |
author_facet | Rodrigues, George Yartsev, Slav Tay, Keng Yeow Pond, Gregory R Lagerwaard, Frank Bauman, Glenn |
author_sort | Rodrigues, George |
collection | PubMed |
description | BACKGROUND: Our research group has previously published a dosimetric planning study that demonstrated that a 60 Gy/10 fractions intralesional boost with whole-brain radiotherapy (WBRT) to 30 Gy/10 fractions was biologically equivalent with a stereotactic radiosurgery (SRS) boost of 18 Gy/1 fraction with 30 Gy/10 fractions WBRT. Helical tomotherapy (HT) was found to be dosimetrically equivalent to SRS in terms of target coverage and superior to SRS in terms of normal tissue tolerance. A phase I trial has been now completed at our institution with a total of 60 enrolled patients and 48 evaluable patients. The phase II dose has been determined to be the final phase I cohort dose of 60 Gy/10 fractions. METHODS/DESIGN: The objective of this clinical trial is to subject the final phase I cohort dose to a phase II assessment of the endpoints of overall survival, intracranial control (ICC) and intralesional control (ILC). We hypothesize HT would be considered unsuitable for further study if the median OS for patients treated with the HT SIB technique is degraded by 2 months, or the intracranial progression-free rates (ICC and ILC) are inferior by 10% or greater compared to the expected results with treatment by whole brain plus SRS as defined by the RTOG randomized trial. A sample size of 93 patients was calculated based on these parameters as well as the statistical assumptions of alpha = 0.025 and beta = 0.1 due to multiple statistical testing. Secondary assessments of toxicity, health-related quality-of-life, cognitive changes, and tumor response are also integrated into this research protocol. DISCUSSION: To summarize, the purpose of this phase II trial is to assess this non-invasive alternative to SRS in terms of central nervous system (CNS) control when compared to SRS historical controls. A follow-up phase III trial may be required depending on the results of this trial in order to definitively assess non-inferiority/superiority of this approach. Ultimately, the purpose of this line of research is to provide patients with metastatic disease to the brain a shorter course, dose intense, non-invasive radiation treatment with equivalent or improved CNS control/survival and health-related quality-of-life/toxicity profile when compared to SRS radiotherapy. TRIAL REGISTRATION: Clinicaltrials.gov - NCT01543542. |
format | Online Article Text |
id | pubmed-3341183 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-33411832012-05-02 A phase II multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases Rodrigues, George Yartsev, Slav Tay, Keng Yeow Pond, Gregory R Lagerwaard, Frank Bauman, Glenn Radiat Oncol Study Protocol BACKGROUND: Our research group has previously published a dosimetric planning study that demonstrated that a 60 Gy/10 fractions intralesional boost with whole-brain radiotherapy (WBRT) to 30 Gy/10 fractions was biologically equivalent with a stereotactic radiosurgery (SRS) boost of 18 Gy/1 fraction with 30 Gy/10 fractions WBRT. Helical tomotherapy (HT) was found to be dosimetrically equivalent to SRS in terms of target coverage and superior to SRS in terms of normal tissue tolerance. A phase I trial has been now completed at our institution with a total of 60 enrolled patients and 48 evaluable patients. The phase II dose has been determined to be the final phase I cohort dose of 60 Gy/10 fractions. METHODS/DESIGN: The objective of this clinical trial is to subject the final phase I cohort dose to a phase II assessment of the endpoints of overall survival, intracranial control (ICC) and intralesional control (ILC). We hypothesize HT would be considered unsuitable for further study if the median OS for patients treated with the HT SIB technique is degraded by 2 months, or the intracranial progression-free rates (ICC and ILC) are inferior by 10% or greater compared to the expected results with treatment by whole brain plus SRS as defined by the RTOG randomized trial. A sample size of 93 patients was calculated based on these parameters as well as the statistical assumptions of alpha = 0.025 and beta = 0.1 due to multiple statistical testing. Secondary assessments of toxicity, health-related quality-of-life, cognitive changes, and tumor response are also integrated into this research protocol. DISCUSSION: To summarize, the purpose of this phase II trial is to assess this non-invasive alternative to SRS in terms of central nervous system (CNS) control when compared to SRS historical controls. A follow-up phase III trial may be required depending on the results of this trial in order to definitively assess non-inferiority/superiority of this approach. Ultimately, the purpose of this line of research is to provide patients with metastatic disease to the brain a shorter course, dose intense, non-invasive radiation treatment with equivalent or improved CNS control/survival and health-related quality-of-life/toxicity profile when compared to SRS radiotherapy. TRIAL REGISTRATION: Clinicaltrials.gov - NCT01543542. BioMed Central 2012-03-21 /pmc/articles/PMC3341183/ /pubmed/22436144 http://dx.doi.org/10.1186/1748-717X-7-42 Text en Copyright ©2012 Rodrigues et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol Rodrigues, George Yartsev, Slav Tay, Keng Yeow Pond, Gregory R Lagerwaard, Frank Bauman, Glenn A phase II multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases |
title | A phase II multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases |
title_full | A phase II multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases |
title_fullStr | A phase II multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases |
title_full_unstemmed | A phase II multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases |
title_short | A phase II multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases |
title_sort | phase ii multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3341183/ https://www.ncbi.nlm.nih.gov/pubmed/22436144 http://dx.doi.org/10.1186/1748-717X-7-42 |
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