From: Subject: BioMed Central | Abstract | 1471-2407-6-133 | Treatment of primary glioblastoma multiforme with cetuximab, radiotherapy and temozolomide (GERT) - phase I/II trial: study protocol Date: Tue, 23 May 2006 10:24:42 +0200 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_00E8_01C67E53.1AD30460" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.2869 This is a multi-part message in MIME format. ------=_NextPart_000_00E8_01C67E53.1AD30460 Content-Type: text/html; charset="utf-8" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.biomedcentral.com/1471-2407/6/133 =EF=BB=BF BioMed Central | = Abstract | 1471-2407-6-133 | Treatment of primary glioblastoma = multiforme with cetuximab, radiotherapy and temozolomide (GERT) - phase = I/II trial: study protocol
  3Dfeedback3D"log  23-May-2006 
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Study = protocol
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Treatment of primary glioblastoma multiforme = with=20 cetuximab, radiotherapy and temozolomide (GERT) - phase I/II = trial: study=20 protocol
Stephanie E Combs = , Steffen Heeger , Renate Haselmann , Lutz Edler , Juergen Debus and Daniela Schulz-Ertner

BMC Cancer 2006,=20 = 6:133     doi:10.1186/1471-2407-6-= 133

=
Published  18 May 2006

Abstract (provisional)

Background

The=20 implementation of combined radiochemotherapy (RCHT) with = temozolomide=20 (TMZ) has lead to a significant increase in overall survival times = in=20 patients with Glioblastoma multiforme (GBM), however, outcome = still=20 remains unsatisfactory. The majority of GBMs show an = overexpression and/or=20 amplification of the epidermal growth factor receptor (EGFR). = Therefore,=20 addition of EGFR-inhibition with cetuximab to the current standard = treatment approach with radiotherapy and TMZ seems promising.

Methods

GERT is a=20 one-armed single-center phase I/II trial. In a first step, = dose-escalation=20 of TMZ from 50 mg/m2 to 75mg/m2 together with radiotherapy and = cetuximab=20 will be performed. Should safety be proven, the phase II trial = will be=20 initiated with the standard dose of 75mg/m2 of TMZ. Cetuximab will = be=20 applied in the standard application dose of 400mg/m2 in week 1, = thereafter=20 at a dose of 250mg/m2 weekly. A total of 46 patients will be = included into=20 this phase I/II trial. Primary endpoints are feasibility and = toxicity,=20 secondary endpoints are overall and progression-free survival. An = interim=20 analysis will be performed after inclusion of 15 patients into the = main=20 study. Patients' enrolment will be performed over a period of 2 = years. The=20 observation time will end 2 years after inclusion of the last = patient.=20

Discussion

The goal of=20 this study is to evaluate the safety and efficacy of combined=20 RCHT-immunotherapy with TMZ and cetuximab as first-line treatment = for=20 patients with primary GBM.


 
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FONT-FAMILY: = Verdana, Geneva, Arial, Helvetica, sans-serif } A:hover { TEXT-DECORATION: underline } .xtoplinks:hover { BACKGROUND-COLOR: #6699ff; TEXT-DECORATION: none } ------=_NextPart_000_00E8_01C67E53.1AD30460 Content-Type: application/octet-stream Content-Transfer-Encoding: quoted-printable Content-Location: http://www.biomedcentral.com/__utm.js //-- Urchin Tracking Module 6.1 (UTM 6.1) $Revision: 1.24 $ //-- Copyright 2004 Urchin Software Corporation, All Rights Reserved. //-- Urchin On Demand Settings ONLY var _u5_uacct=3D""; // set up the Urchin Account var _u5_userv=3D0; // service mode (0=3Dlocal,1=3Dremote,2=3Dboth) //-- UTM User Settings var _u5_ufsc=3D1; // set client info flag (1=3Don|0=3Doff) var _u5_udn=3D"auto"; // (auto|none|domain) set the domain name for = cookies var _u5_uhash=3D"on"; // (on|off) unique domain hash for cookies var _u5_utimeout=3D"1800"; // set the inactive session timeout in = seconds var _u5_ugifpath=3D"/__utm.gif"; // set the web path to the __utm.gif = file var _u5_utsp=3D"|"; // transaction field separator var _u5_uflash=3D1; // set flash version detect option = (1=3Don|0=3Doff) var _u5_utitle=3D1; // set the document title detect option = (1=3Don|0=3Doff) //-- UTM Campaign Tracking Settings var _u5_uctm=3D0; // set campaign tracking module (1=3Don|0=3Doff) var _u5_ucto=3D"15768000"; // set timeout in seconds (6 month default) var _u5_uccn=3D"utm_campaign"; // name var _u5_ucmd=3D"utm_medium"; // medium (cpc|cpm|link|email|organic) var _u5_ucsr=3D"utm_source"; // source var _u5_uctr=3D"utm_term"; // term/keyword var _u5_ucct=3D"utm_content"; // content var _u5_ucid=3D"utm_id"; // id number var _u5_ucno=3D"utm_nooverride"; // don't override //-- Auto/Organic Sources and Keywords var _u5_uOsr=3Dnew Array(); var _u5_uOkw=3Dnew Array(); _u5_uOsr[0]=3D"google"; _u5_uOkw[0]=3D"q"; _u5_uOsr[1]=3D"yahoo"; _u5_uOkw[1]=3D"p"; _u5_uOsr[2]=3D"msn"; _u5_uOkw[2]=3D"q"; _u5_uOsr[3]=3D"aol"; _u5_uOkw[3]=3D"query"; _u5_uOsr[4]=3D"lycos"; 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Date(_u5_udt.getTime()+(_u5_utimeout*1000)); x=3D" expires=3D"+x.toGMTString()+";"; } s=3D_u5_udl.search; if(s && s!=3D"" && s.indexOf("__utma=3D")>=3D0) { a=3D_u5_uGC(s,"__utma=3D","&"); b=3D_u5_uGC(s,"__utmb=3D","&"); c=3D_u5_uGC(s,"__utmc=3D","&"); if (a!=3D"-" && b!=3D"-" && c!=3D"-") f=3D1; else if(a!=3D"-") f=3D2; } if(f=3D=3D1) { _u5_ubd.cookie=3D"__utma=3D"+a+"; path=3D/;"+nx; _u5_ubd.cookie=3D"__utmb=3D"+b+"; path=3D/;"+x; _u5_ubd.cookie=3D"__utmc=3D"+c+"; path=3D/;"; } else if (f=3D=3D2) { a=3D_u5_uFixA(s,"&",_u5_ust); _u5_ubd.cookie=3D"__utma=3D"+a+"; path=3D/;"+nx; _u5_ubd.cookie=3D"__utmb=3D"+_u5_udh+"; path=3D/;"+x; _u5_ubd.cookie=3D"__utmc=3D"+_u5_udh+"; path=3D/;"; _u5_ufns=3D1; } else if (a>=3D0 && b>=3D0 && c>=3D0) { _u5_ubd.cookie=3D"__utmb=3D"+_u5_udh+"; path=3D/;"+x+_u5_udo; } else { if (a>=3D0) a=3D_u5_uFixA(_u5_ubd.cookie,";",_u5_ust); else a=3D_u5_udh+"."+_u5_uu+"."+_u5_ust+"."+_u5_ust+"."+_u5_ust+".1"; _u5_ubd.cookie=3D"__utma=3D"+a+"; path=3D/;"+nx+_u5_udo; _u5_ubd.cookie=3D"__utmb=3D"+_u5_udh+"; path=3D/;"+x+_u5_udo; _u5_ubd.cookie=3D"__utmc=3D"+_u5_udh+"; path=3D/;"+_u5_udo; _u5_ufns=3D1; } if (s && s!=3D"" && s.indexOf("__utmv=3D")>=3D0) { if ((v=3D_u5_uGC(s,"__utmv=3D","&"))!=3D"-") { _u5_ubd.cookie=3D"__utmv=3D"+unescape(v)+"; path=3D/;"+nx+_u5_udo; } } _u5_uInfo(page); _u5_ufns=3D0; _u5_ufno=3D0; _u5_uff=3D1; } u5_urchinTracker(); function _u5_uInfo(page) { var p,s=3D"",pg=3D_u5_udl.pathname+_u5_udl.search; if (page && page!=3D"") pg=3Descape(page); _u5_ur=3D_u5_ubd.referrer; if (!_u5_ur || _u5_ur=3D=3D"") { _u5_ur=3D"-"; } else { p=3D_u5_ur.indexOf(_u5_ubd.domain); if ((p>=3D0) && (p<=3D8)) { _u5_ur=3D"0"; } if (_u5_ur.indexOf("[")=3D=3D0 && = _u5_ur.lastIndexOf("]")=3D=3D(_u5_ur.length-1)) { _u5_ur=3D"-"; } } s+=3D"&utmn=3D"+_u5_uu; if (_u5_ufsc) s+=3D_u5_uBInfo(page); if (_u5_uctm && (!page || page=3D=3D"")) s+=3D_u5_uCInfo(); if (_u5_utitle && _u5_ubd.title && _u5_ubd.title!=3D"") = s+=3D"&utmdt=3D"+escape(_u5_ubd.title); if 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z=3Ddc.indexOf("__utmz=3D"+_u5_udh); if (z>-1) { z=3D_u5_uGC(dc,"__utmz=3D"+_u5_udh,";"); } else { z=3D"-"; } t=3D_u5_uGC(s,_u5_ucid+"=3D","&"); t2=3D_u5_uGC(s,_u5_ucsr+"=3D","&"); if ((t!=3D"-" && t!=3D"") || (t2!=3D"-" && t2!=3D"")) { if (t!=3D"-" && t!=3D"") { c+=3D"utmcid=3D"+_u5_uEC(t); if (t2!=3D"-" = && t2!=3D"") c+=3D"|utmcsr=3D"+_u5_uEC(t2); } else { if (t2!=3D"-" && t2!=3D"") c+=3D"utmcsr=3D"+_u5_uEC(t2); } t=3D_u5_uGC(s,_u5_uccn+"=3D","&"); if (t!=3D"-" && t!=3D"") c+=3D"|utmccn=3D"+_u5_uEC(t); else c+=3D"|utmccn=3D(not+set)"; t=3D_u5_uGC(s,_u5_ucmd+"=3D","&"); if (t!=3D"-" && t!=3D"") c+=3D"|utmcmd=3D"+_u5_uEC(t); else c+=3D"|utmcmd=3D(not+set)"; t=3D_u5_uGC(s,_u5_uctr+"=3D","&"); if (t!=3D"-" && t!=3D"") c+=3D"|utmctr=3D"+_u5_uEC(t); else { t=3D_u5_uOrg(1); if (t!=3D"-" && t!=3D"") = c+=3D"|utmctr=3D"+_u5_uEC(t); } t=3D_u5_uGC(s,_u5_ucct+"=3D","&"); if (t!=3D"-" && t!=3D"") c+=3D"|utmcct=3D"+_u5_uEC(t); t=3D_u5_uGC(s,_u5_ucno+"=3D","&"); if (t=3D=3D"1") o=3D1; if (z!=3D"-" && o=3D=3D1) return ""; } if (c=3D=3D"-" || c=3D=3D"") { c=3D_u5_uOrg(); if (z!=3D"-" && = _u5_ufno=3D=3D1) return ""; } if (c=3D=3D"-" || c=3D=3D"") { if (_u5_ufns=3D=3D1) c=3D_u5_uRef(); if = (z!=3D"-" && _u5_ufno=3D=3D1) return ""; } if (c=3D=3D"-" || c=3D=3D"") { if (z=3D=3D"-" && _u5_ufns=3D=3D1) { = c=3D"utmccn=3D(direct)|utmcsr=3D(direct)|utmcmd=3D(none)"; } if (c=3D=3D"-" || c=3D=3D"") return ""; } if (z!=3D"-") { i=3Dz.indexOf("."); if (i>-1) i=3Dz.indexOf(".",i+1); if (i>-1) i=3Dz.indexOf(".",i+1); if (i>-1) i=3Dz.indexOf(".",i+1); t=3Dz.substring(i+1,z.length); if (t.toLowerCase()=3D=3Dc.toLowerCase()) cs=3D1; t=3Dz.substring(0,i); if ((i=3Dt.lastIndexOf(".")) > -1) { t=3Dt.substring(i+1,t.length); cn=3D(t*1); } } if (cs=3D=3D0 || _u5_ufns=3D=3D1) { t=3D_u5_uGC(dc,"__utma=3D"+_u5_udh,";"); if ((i=3Dt.lastIndexOf(".")) > 9) { _u5_uns=3Dt.substring(i+1,t.length); _u5_uns=3D(_u5_uns*1); } cn++; if (_u5_uns=3D=3D0) _u5_uns=3D1; = 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