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Neoadjuvant stereotactic radiosurgery for intracerebral metastases of solid tumors(NepoMUC):a phase I dose escalation trial

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Cancer Communications 2019年第1期39卷 623-631页

作者： Christian D.Diehl Ehab Shiban Christoph Straube Jens Gempt Jan J.Wilkens Markus Oechsner Carmen Kessel Claus Zimmer benedict wiestler Bernhard Meyer Stephanie E.Combs Department of Radiation Oncology Klinikum rechts der Isar HospitalTechnical University of MunichIsmaninger Straße 2281675 MunichGermany Department of Radiation Sciences Institute of Innovative Radiotherapy85764 NeuherbergGermany Department of Neurosurgery Klinikum rechts der Isar HospitalTechnical University of Munich81675 MunichGermany Department of Diagnostic and Interventional Neuroradiology Klinikum rechts der Isar HospitalTechnical University of Munich81675 MunichGermany

Background:More than 25%of patients with solid cancers develop intracerebral *** of surgery,radia-tion therapy(RT)is a mainstay in the treatment of intracerebral *** fractionated stereotactic RT(FSRT)to the resection cavity of intracerebral metastases is a treatment of choice to reduce the risk of local ***,FSRT has to be delayed until a sufficient wound healing is attained;hence systemic therapy might be *** stereotactic radiosurgery(SRS)might offer advantages over adjuvant FSRT in terms of better target delineation and an earlier start of systemic ***,we conducted a study to find the maximum tolerated dose(MTD)of neoadjuvant SRS for intracerebral ***:This is a single-center,phase I dose escalation study on neoadjuvant SRS for intracerebral metastases that will be conducted at the Klinikum rechts der Isar Hospital,Technical University of *** rule-based traditional 3+3 design for this trial with 3 dose levels and 4 different cohorts depending on lesion size will be *** primary endpoint is the MTD for which no dose-limiting toxicities(DLT)*** adverse events of each participant will be evaluated according to the Common Terminology Criteria for Adverse Events(CTCAE)version 5.0 continuously during the study until the first follow-up visit(4-6 weeks after surgery).Secondary endpoints include local control rate,survival,immunological tumor characteristics,quality of life(QoL),CTCAE grade of late clinical,neurological,and neurocognitive *** addition to the intracerebral metastasis which is treated with neoadjuvant SRS and resection up to four additional intracerebral metastases can be treated with definitive *** on the occurrence of DLT up to 72 patients will be *** recruitment phase will last for 24 ***:Neoadjuvant SRS for intracerebral metastases offers potential advantages over postoperative SRS to the resection

关键词： Cancer Intracerebral metastasis Stereotactic radiosurgery Fractionated stereotactic radiation therapy Microsurgical resection Neoadjuvant radiation therapy Maximum tolerated dose Protocol

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