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Prospective
Clinical Trials of Brain Tumor Therapy: The Critical Role of Neurosurgeons
Frederick F. Lang, Anthony
Asher
Department
of Neurosurgery and The Brain Tumor Center, The University of Texas MD Anderson
Cancer Center, Department of Neurosurgery, Unit 442, 1515 Holcombe Boulevard,
Houston, TX 77030, USA; Tel.: +1-713-792-2400; Fax: +1-713-745-4341;E-mail: flang@mdanderson
[F.F.L.]. Carolina Neurosurgery & Spine Associates,
Charlotte, NC, USA [A.A.].
Prospective
clinical trials are critical to the scientific evaluation of new treatments for
brain tumors.
This paper reviews basic concepts of early and late phase prospective clinical
trials that are most relevant to neurosurgical oncologists, with an emphasis on
the challenges associated with conducting clinical trials of brain tumor
therapies.
Novel clinical trial designs that meet these challenges by incorporating
pretreatment “molecular
profiling”
and post-treatment “molecular
endpoints”
are described.
Because of their ability to obtain brain tumor specimens from patients before
and after treatment, neurosurgeons have been required to play an increasingly
important role in the execution of these molecular-based clinical trials.
Potential avenues for enhancing the participation of neurosurgeons in the design
and development of clinical trials are discussed.
Keywords: brain
tumor, clinical trial, glioblastoma, molecular endpoint, molecular profile
Copyright
©
2004 Kluwer Academic Publishers.
All rights reserved
Source: http://ipsapp007.kluweronline.com/IPS/content/ext/x/J/5042/I/124/A/11/abstract.htm
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