Challenges relating to solid tumour brain metastases in clinical trials, part 2: neurocognitive, neurological, and quality-of-life outcomes. A report from the RANO group
Summary Neurocognitive function, neurological symptoms, functional independence, and health-related quality of life are major concerns for patients with brain metastases. The inclusion of these endpoints in trials of brain metastases and the methods by which these measures are assessed vary substant...
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| Veröffentlicht in: | The lancet oncology 2013-09, Vol.14 (10), p.e407-e416 |
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| creator | Lin, Nancy U, Dr Wefel, Jeffrey S, PhD Lee, Eudocia Q, MD Schiff, David, Prof van den Bent, Martin J, Prof Soffietti, Riccardo, Prof Suh, John H, Prof Vogelbaum, Michael A, Prof Mehta, Minesh P, MD Dancey, Janet, Prof Linskey, Mark E, Prof Camidge, D Ross, MD Aoyama, Hidefumi, Prof Brown, Paul D, Prof Chang, Susan M, Prof Kalkanis, Steven N, MD Barani, Igor J, MD Baumert, Brigitta G, Prof Gaspar, Laurie E, Prof Hodi, F Stephen, MD Macdonald, David R, MD Wen, Patrick Y, Prof |
| description | Summary Neurocognitive function, neurological symptoms, functional independence, and health-related quality of life are major concerns for patients with brain metastases. The inclusion of these endpoints in trials of brain metastases and the methods by which these measures are assessed vary substantially. If functional independence or health-related quality of life are planned as key study outcomes, then the reliability and validity of these endpoints can be crucial because methodological issues might affect the interpretation and acceptance of findings. The Response Assessment in Neuro-Oncology (RANO) working group is an independent, international, and collaborative effort to improve the design of clinical trials in patients with brain tumours. In this report, the second in a two-part series, we review clinical trials of brain metastases in relation to measures of clinical benefit and provide a framework for the design and conduct of future trials. |
| doi_str_mv | 10.1016/S1470-2045(13)70308-5 |
| format | Article |
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A report from the RANO group</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Lin, Nancy U, Dr ; Wefel, Jeffrey S, PhD ; Lee, Eudocia Q, MD ; Schiff, David, Prof ; van den Bent, Martin J, Prof ; Soffietti, Riccardo, Prof ; Suh, John H, Prof ; Vogelbaum, Michael A, Prof ; Mehta, Minesh P, MD ; Dancey, Janet, Prof ; Linskey, Mark E, Prof ; Camidge, D Ross, MD ; Aoyama, Hidefumi, Prof ; Brown, Paul D, Prof ; Chang, Susan M, Prof ; Kalkanis, Steven N, MD ; Barani, Igor J, MD ; Baumert, Brigitta G, Prof ; Gaspar, Laurie E, Prof ; Hodi, F Stephen, MD ; Macdonald, David R, MD ; Wen, Patrick Y, Prof</creator><creatorcontrib>Lin, Nancy U, Dr ; Wefel, Jeffrey S, PhD ; Lee, Eudocia Q, MD ; Schiff, David, Prof ; van den Bent, Martin J, Prof ; Soffietti, Riccardo, Prof ; Suh, John H, Prof ; Vogelbaum, Michael A, Prof ; Mehta, Minesh P, MD ; Dancey, Janet, Prof ; Linskey, Mark E, Prof ; Camidge, D Ross, MD ; Aoyama, Hidefumi, Prof ; Brown, Paul D, Prof ; Chang, Susan M, Prof ; Kalkanis, Steven N, MD ; Barani, Igor J, MD ; Baumert, Brigitta G, Prof ; Gaspar, Laurie E, Prof ; Hodi, F Stephen, MD ; Macdonald, David R, MD ; Wen, Patrick Y, Prof ; for the Response Assessment in Neuro-Oncology (RANO) group ; Response Assessment in Neuro-Oncology (RANO) group</creatorcontrib><description>Summary Neurocognitive function, neurological symptoms, functional independence, and health-related quality of life are major concerns for patients with brain metastases. The inclusion of these endpoints in trials of brain metastases and the methods by which these measures are assessed vary substantially. If functional independence or health-related quality of life are planned as key study outcomes, then the reliability and validity of these endpoints can be crucial because methodological issues might affect the interpretation and acceptance of findings. The Response Assessment in Neuro-Oncology (RANO) working group is an independent, international, and collaborative effort to improve the design of clinical trials in patients with brain tumours. In this report, the second in a two-part series, we review clinical trials of brain metastases in relation to measures of clinical benefit and provide a framework for the design and conduct of future trials.</description><identifier>ISSN: 1470-2045</identifier><identifier>EISSN: 1474-5488</identifier><identifier>DOI: 10.1016/S1470-2045(13)70308-5</identifier><identifier>PMID: 23993385</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Brain cancer ; Brain Neoplasms - psychology ; Brain Neoplasms - secondary ; Brain research ; Cancer therapies ; Clinical trials ; Clinical Trials as Topic ; Cognition ; Disease control ; Effectiveness ; Hematology, Oncology and Palliative Medicine ; Humans ; Medical prognosis ; Metastasis ; Patients ; Quality of Life ; Radiation therapy ; Radiosurgery ; Research Design ; Surgery ; Toxicity</subject><ispartof>The lancet oncology, 2013-09, Vol.14 (10), p.e407-e416</ispartof><rights>Elsevier Ltd</rights><rights>2013 Elsevier Ltd</rights><rights>Copyright © 2013 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Sep 2013</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c481t-d8f268b5af20210c11cbad11fdebde8a435853ecb77ff9e308bffabb2c6e0c983</citedby><cites>FETCH-LOGICAL-c481t-d8f268b5af20210c11cbad11fdebde8a435853ecb77ff9e308bffabb2c6e0c983</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1470204513703085$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23993385$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lin, Nancy U, Dr</creatorcontrib><creatorcontrib>Wefel, Jeffrey S, PhD</creatorcontrib><creatorcontrib>Lee, Eudocia Q, MD</creatorcontrib><creatorcontrib>Schiff, David, Prof</creatorcontrib><creatorcontrib>van den Bent, Martin J, Prof</creatorcontrib><creatorcontrib>Soffietti, Riccardo, Prof</creatorcontrib><creatorcontrib>Suh, John H, Prof</creatorcontrib><creatorcontrib>Vogelbaum, Michael A, Prof</creatorcontrib><creatorcontrib>Mehta, Minesh P, MD</creatorcontrib><creatorcontrib>Dancey, Janet, Prof</creatorcontrib><creatorcontrib>Linskey, Mark E, Prof</creatorcontrib><creatorcontrib>Camidge, D Ross, MD</creatorcontrib><creatorcontrib>Aoyama, Hidefumi, Prof</creatorcontrib><creatorcontrib>Brown, Paul D, Prof</creatorcontrib><creatorcontrib>Chang, Susan M, Prof</creatorcontrib><creatorcontrib>Kalkanis, Steven N, MD</creatorcontrib><creatorcontrib>Barani, Igor J, MD</creatorcontrib><creatorcontrib>Baumert, Brigitta G, Prof</creatorcontrib><creatorcontrib>Gaspar, Laurie E, Prof</creatorcontrib><creatorcontrib>Hodi, F Stephen, MD</creatorcontrib><creatorcontrib>Macdonald, David R, MD</creatorcontrib><creatorcontrib>Wen, Patrick Y, Prof</creatorcontrib><creatorcontrib>for the Response Assessment in Neuro-Oncology (RANO) group</creatorcontrib><creatorcontrib>Response Assessment in Neuro-Oncology (RANO) group</creatorcontrib><title>Challenges relating to solid tumour brain metastases in clinical trials, part 2: neurocognitive, neurological, and quality-of-life outcomes. A report from the RANO group</title><title>The lancet oncology</title><addtitle>Lancet Oncol</addtitle><description>Summary Neurocognitive function, neurological symptoms, functional independence, and health-related quality of life are major concerns for patients with brain metastases. The inclusion of these endpoints in trials of brain metastases and the methods by which these measures are assessed vary substantially. If functional independence or health-related quality of life are planned as key study outcomes, then the reliability and validity of these endpoints can be crucial because methodological issues might affect the interpretation and acceptance of findings. The Response Assessment in Neuro-Oncology (RANO) working group is an independent, international, and collaborative effort to improve the design of clinical trials in patients with brain tumours. In this report, the second in a two-part series, we review clinical trials of brain metastases in relation to measures of clinical benefit and provide a framework for the design and conduct of future trials.</description><subject>Brain cancer</subject><subject>Brain Neoplasms - psychology</subject><subject>Brain Neoplasms - secondary</subject><subject>Brain research</subject><subject>Cancer therapies</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic</subject><subject>Cognition</subject><subject>Disease control</subject><subject>Effectiveness</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>Medical prognosis</subject><subject>Metastasis</subject><subject>Patients</subject><subject>Quality of Life</subject><subject>Radiation therapy</subject><subject>Radiosurgery</subject><subject>Research Design</subject><subject>Surgery</subject><subject>Toxicity</subject><issn>1470-2045</issn><issn>1474-5488</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqFkttq3DAQhk1padK0j9Ai6E0K61QHay33omVZeoLQQA_XQpZHG6Wy5UhyYB-pb1l5nbSQm4BAGvHNP5r5VRQvCT4jmKzf_iBVjUuKK35K2JsaMyxK_qg4ztdVySshHh_OC3JUPIvxCmNSE8yfFkeUNQ1jgh8Xf7aXyjkYdhBRAKeSHXYoeRS9sx1KU--ngNqg7IB6SCrmlckcaWcHq5VDKVjl4gqNKiRE36EBpuC13w022RtYLbHzuxleITV06HpSzqZ96U3prAHkp6R9D_EMbfIbRp91TPA9SpeAvm--XaBd8NP4vHhiciF4cbufFL8-ffy5_VKeX3z-ut2cl7oSJJWdMHQtWq4MxZRgTYhuVUeI6aDtQKiKccEZ6LaujWkgj601RrUt1WvAuhHspDhddMfgryeISfY2anBODeCnKEnNSRamTfUwWtFmzRpKZvT1PfQqT3bIjcyUYAw3fKb4QungYwxg5Bhsr8JeEixn2-XBdjl7KgmTB9slz3mvbtWntofuX9adzxn4sACQJ3djIcioLQwaOhtAJ9l5-2CJ9_cU7n7Ab9hD_N-NjFTiRWTWIOygwNlfGnnTqw</recordid><startdate>20130901</startdate><enddate>20130901</enddate><creator>Lin, Nancy U, Dr</creator><creator>Wefel, Jeffrey S, PhD</creator><creator>Lee, Eudocia Q, MD</creator><creator>Schiff, David, Prof</creator><creator>van den Bent, Martin J, Prof</creator><creator>Soffietti, Riccardo, Prof</creator><creator>Suh, John H, Prof</creator><creator>Vogelbaum, Michael A, Prof</creator><creator>Mehta, Minesh P, MD</creator><creator>Dancey, Janet, Prof</creator><creator>Linskey, Mark E, Prof</creator><creator>Camidge, D Ross, MD</creator><creator>Aoyama, Hidefumi, Prof</creator><creator>Brown, Paul D, Prof</creator><creator>Chang, Susan M, Prof</creator><creator>Kalkanis, Steven N, MD</creator><creator>Barani, Igor J, MD</creator><creator>Baumert, Brigitta G, Prof</creator><creator>Gaspar, Laurie E, Prof</creator><creator>Hodi, F Stephen, MD</creator><creator>Macdonald, David R, MD</creator><creator>Wen, Patrick Y, Prof</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>3V.</scope><scope>7RV</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8C2</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20130901</creationdate><title>Challenges relating to solid tumour brain metastases in clinical trials, part 2: neurocognitive, neurological, and quality-of-life outcomes. 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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Brain cancer Brain Neoplasms - psychology Brain Neoplasms - secondary Brain research Cancer therapies Clinical trials Clinical Trials as Topic Cognition Disease control Effectiveness Hematology, Oncology and Palliative Medicine Humans Medical prognosis Metastasis Patients Quality of Life Radiation therapy Radiosurgery Research Design Surgery Toxicity |
| title | Challenges relating to solid tumour brain metastases in clinical trials, part 2: neurocognitive, neurological, and quality-of-life outcomes. A report from the RANO group |
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