000177560 001__ 177560
000177560 005__ 20240229133743.0
000177560 0247_ $$2doi$$a10.1016/j.esmoop.2021.100310
000177560 0247_ $$2pmid$$apmid:34808524
000177560 037__ $$aDKFZ-2021-02627
000177560 041__ $$aEnglish
000177560 082__ $$a610
000177560 1001_ $$0P:(DE-He78)42b6114cd48e033299b2b6ef4bf56cc6$$aHeilig, Christoph$$b0$$eFirst author$$udkfz
000177560 245__ $$aRationale and design of the CRAFT (Continuous ReAssessment with Flexible ExTension in Rare Malignancies) multicenter phase II trial.
000177560 260__ $$aLondon$$bBMJ$$c2021
000177560 3367_ $$2DRIVER$$aarticle
000177560 3367_ $$2DataCite$$aOutput Types/Journal article
000177560 3367_ $$0PUB:(DE-HGF)16$$2PUB:(DE-HGF)$$aJournal Article$$bjournal$$mjournal$$s1637681040_30858
000177560 3367_ $$2BibTeX$$aARTICLE
000177560 3367_ $$2ORCID$$aJOURNAL_ARTICLE
000177560 3367_ $$00$$2EndNote$$aJournal Article
000177560 500__ $$a#EA:B340#
000177560 520__ $$aApprovals of cancer therapeutics are primarily disease entity specific. Current molecular diagnostic approaches frequently identify actionable alterations in rare cancers or rare subtypes of common cancers for which the corresponding treatments are not approved and unavailable within clinical trials due to entity-related eligibility criteria. Access may be negotiated with health insurances. However, approval rates vary, and critical information required for a scientific evaluation of treatment-associated risks and benefits is not systematically collected. Thus clinical trials with optimized patient selection and comprehensive molecular characterization are essential for translating experimental treatments into standard care.Continuous ReAssessment with Flexible ExTension in Rare Malignancies (CRAFT) is an open-label phase II trial for adults with pretreated, locally advanced, or metastatic solid tumors. Based on the evaluation by a molecular tumor board, patients are assigned to combinations of six molecularly targeted agents and a programmed death-ligand 1 (PD-L1) antagonist within seven study arms focusing on (i) BRAF V600 mutations; (ii) ERBB2 amplification and/or overexpression, activating ERBB2 mutations; (iii) ALK rearrangements, activating ALK mutations; (iv and v) activating PIK3CA and AKT mutations, other aberrations predicting increased PI3K-AKT pathway activity; (vi) aberrations predicting increased RAF-MEK-ERK pathway activity; (vii) high tumor mutational burden and other alterations predicting sensitivity to PD-L1 inhibition. The primary endpoint is the disease control rate (DCR) at week 16; secondary and exploratory endpoints include the progression-free survival ratio, overall survival, and patient-reported outcomes. Using Simon's optimal two-stage design, 14 patients are accrued for each study arm. If three or fewer patients achieve disease control, the study arm is stopped. Otherwise, 11 additional patients are accrued. If the DCR exceeds 7 of 25 patients, the null hypothesis is rejected for the respective study arm.CRAFT was activated in October 2021 and will recruit at 10 centers in Germany.EudraCT: 2019-003192-18; ClinicalTrials.gov: NCT04551521.
000177560 536__ $$0G:(DE-HGF)POF4-312$$a312 - Funktionelle und strukturelle Genomforschung (POF4-312)$$cPOF4-312$$fPOF IV$$x0
000177560 588__ $$aDataset connected to CrossRef, PubMed, , Journals: inrepo01.inet.dkfz-heidelberg.de
000177560 650_7 $$2Other$$aclinical trial in progress
000177560 650_7 $$2Other$$aimmunotherapy
000177560 650_7 $$2Other$$aprecision oncology
000177560 650_7 $$2Other$$atarget therapy
000177560 7001_ $$0P:(DE-He78)5ea1944c122bc098a81df27a05572719$$aHorak, P.$$b1$$udkfz
000177560 7001_ $$0P:(DE-He78)e5972dddc3c8d1412db29ba54fed83ba$$aKreutzfeldt, S.$$b2$$udkfz
000177560 7001_ $$0P:(DE-He78)4e4e534b615747750de8b9a7afdd8f56$$aTeleanu, V.$$b3$$udkfz
000177560 7001_ $$0P:(DE-He78)8f7c3bc1451193551c2458d93222536a$$aMock, A.$$b4$$udkfz
000177560 7001_ $$0P:(DE-He78)1d432d6addb08c1c31c8934bc8d40992$$aRenner, M.$$b5$$udkfz
000177560 7001_ $$0P:(DE-He78)f72524669e71afff395a16e54bfe22d6$$aBhatti, I. A.$$b6$$udkfz
000177560 7001_ $$0P:(DE-He78)135e8c8d1dd1b66b8127c3d1e3a9b6a0$$aHutter, B.$$b7$$udkfz
000177560 7001_ $$0P:(DE-He78)c9be4ab60d1090c3d315a2ca6905e9ea$$aHüllein, J.$$b8$$udkfz
000177560 7001_ $$0P:(DE-He78)a15aa7d740f286aad9d8139d515e866c$$aFröhlich, M.$$b9$$udkfz
000177560 7001_ $$0P:(DE-He78)a8e85c1bd89741ab0c2a28032ba81359$$aUhrig, S.$$b10$$udkfz
000177560 7001_ $$aSüße, H.$$b11
000177560 7001_ $$aHeiligenthal, L.$$b12
000177560 7001_ $$0P:(DE-HGF)0$$aOchsenreither, S.$$b13
000177560 7001_ $$0P:(DE-HGF)0$$aIllert, A. L.$$b14
000177560 7001_ $$aVogel, A.$$b15
000177560 7001_ $$0P:(DE-HGF)0$$aDesuki, A.$$b16
000177560 7001_ $$0P:(DE-HGF)0$$aHeinemann, V.$$b17
000177560 7001_ $$0P:(DE-HGF)0$$aHeidegger, S.$$b18
000177560 7001_ $$0P:(DE-HGF)0$$aBitzer, M.$$b19
000177560 7001_ $$aScheytt, M.$$b20
000177560 7001_ $$0P:(DE-He78)fc949170377b58098e46141d95c72661$$aBrors, B.$$b21$$udkfz
000177560 7001_ $$0P:(DE-He78)a5218e4871866cd5ab2312e594ca403d$$aHübschmann, D.$$b22$$udkfz
000177560 7001_ $$aBaretton, G.$$b23
000177560 7001_ $$0P:(DE-HGF)0$$aStenzinger, A.$$b24
000177560 7001_ $$0P:(DE-He78)a0c2037d9054be26907a05ae520d5756$$aSteindorf, K.$$b25$$udkfz
000177560 7001_ $$0P:(DE-He78)e15dfa1260625c69d6690a197392a994$$aBenner, A.$$b26$$udkfz
000177560 7001_ $$aJäger, D.$$b27
000177560 7001_ $$0P:(DE-He78)1464357f7ec5faf677a390a414e50c88$$aHeining, C.$$b28$$udkfz
000177560 7001_ $$0P:(DE-He78)157277fe62f07df1732f9d126a51d1b9$$aGlimm, H.$$b29$$udkfz
000177560 7001_ $$0P:(DE-He78)f0144d171d26dbedb67c9db1df35629d$$aFröhling, S.$$b30$$udkfz
000177560 7001_ $$0P:(DE-He78)d8a0e60e5e095f3161ee0de3712409bc$$aSchlenk, R. F.$$b31$$udkfz
000177560 773__ $$0PERI:(DE-600)2844985-X$$a10.1016/j.esmoop.2021.100310$$gVol. 6, no. 6, p. 100310 -$$n6$$p100310$$tESMO open$$v6$$x2059-7029$$y2021
000177560 909CO $$ooai:inrepo02.dkfz.de:177560$$pVDB
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)42b6114cd48e033299b2b6ef4bf56cc6$$aDeutsches Krebsforschungszentrum$$b0$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)5ea1944c122bc098a81df27a05572719$$aDeutsches Krebsforschungszentrum$$b1$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)e5972dddc3c8d1412db29ba54fed83ba$$aDeutsches Krebsforschungszentrum$$b2$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)4e4e534b615747750de8b9a7afdd8f56$$aDeutsches Krebsforschungszentrum$$b3$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)8f7c3bc1451193551c2458d93222536a$$aDeutsches Krebsforschungszentrum$$b4$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)1d432d6addb08c1c31c8934bc8d40992$$aDeutsches Krebsforschungszentrum$$b5$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)f72524669e71afff395a16e54bfe22d6$$aDeutsches Krebsforschungszentrum$$b6$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)135e8c8d1dd1b66b8127c3d1e3a9b6a0$$aDeutsches Krebsforschungszentrum$$b7$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)c9be4ab60d1090c3d315a2ca6905e9ea$$aDeutsches Krebsforschungszentrum$$b8$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)a15aa7d740f286aad9d8139d515e866c$$aDeutsches Krebsforschungszentrum$$b9$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)a8e85c1bd89741ab0c2a28032ba81359$$aDeutsches Krebsforschungszentrum$$b10$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-HGF)0$$aDeutsches Krebsforschungszentrum$$b13$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-HGF)0$$aDeutsches Krebsforschungszentrum$$b14$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-HGF)0$$aDeutsches Krebsforschungszentrum$$b16$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-HGF)0$$aDeutsches Krebsforschungszentrum$$b17$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-HGF)0$$aDeutsches Krebsforschungszentrum$$b18$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-HGF)0$$aDeutsches Krebsforschungszentrum$$b19$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)fc949170377b58098e46141d95c72661$$aDeutsches Krebsforschungszentrum$$b21$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)a5218e4871866cd5ab2312e594ca403d$$aDeutsches Krebsforschungszentrum$$b22$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-HGF)0$$aDeutsches Krebsforschungszentrum$$b24$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)a0c2037d9054be26907a05ae520d5756$$aDeutsches Krebsforschungszentrum$$b25$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)e15dfa1260625c69d6690a197392a994$$aDeutsches Krebsforschungszentrum$$b26$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)1464357f7ec5faf677a390a414e50c88$$aDeutsches Krebsforschungszentrum$$b28$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)157277fe62f07df1732f9d126a51d1b9$$aDeutsches Krebsforschungszentrum$$b29$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)f0144d171d26dbedb67c9db1df35629d$$aDeutsches Krebsforschungszentrum$$b30$$kDKFZ
000177560 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)d8a0e60e5e095f3161ee0de3712409bc$$aDeutsches Krebsforschungszentrum$$b31$$kDKFZ
000177560 9131_ $$0G:(DE-HGF)POF4-312$$1G:(DE-HGF)POF4-310$$2G:(DE-HGF)POF4-300$$3G:(DE-HGF)POF4$$4G:(DE-HGF)POF$$aDE-HGF$$bGesundheit$$lKrebsforschung$$vFunktionelle und strukturelle Genomforschung$$x0
000177560 9141_ $$y2021
000177560 915__ $$0StatID:(DE-HGF)0200$$2StatID$$aDBCoverage$$bSCOPUS$$d2020-09-06
000177560 915__ $$0StatID:(DE-HGF)0300$$2StatID$$aDBCoverage$$bMedline$$d2020-09-06
000177560 915__ $$0StatID:(DE-HGF)0320$$2StatID$$aDBCoverage$$bPubMed Central$$d2020-09-06
000177560 915__ $$0StatID:(DE-HGF)0501$$2StatID$$aDBCoverage$$bDOAJ Seal$$d2020-09-06
000177560 915__ $$0StatID:(DE-HGF)0500$$2StatID$$aDBCoverage$$bDOAJ$$d2020-09-06
000177560 915__ $$0StatID:(DE-HGF)0030$$2StatID$$aPeer Review$$bDOAJ : Blind peer review$$d2020-09-06
000177560 915__ $$0LIC:(DE-HGF)CCBYNCNV$$2V:(DE-HGF)$$aCreative Commons Attribution-NonCommercial CC BY-NC (No Version)$$bDOAJ$$d2020-09-06
000177560 915__ $$0StatID:(DE-HGF)0199$$2StatID$$aDBCoverage$$bClarivate Analytics Master Journal List$$d2020-09-06
000177560 915__ $$0StatID:(DE-HGF)1030$$2StatID$$aDBCoverage$$bCurrent Contents - Life Sciences$$d2020-09-06
000177560 915__ $$0StatID:(DE-HGF)0160$$2StatID$$aDBCoverage$$bEssential Science Indicators$$d2020-09-06
000177560 915__ $$0StatID:(DE-HGF)0113$$2StatID$$aWoS$$bScience Citation Index Expanded$$d2020-09-06
000177560 915__ $$0StatID:(DE-HGF)0150$$2StatID$$aDBCoverage$$bWeb of Science Core Collection$$d2020-09-06
000177560 915__ $$0StatID:(DE-HGF)0561$$2StatID$$aArticle Processing Charges$$d2020-09-06
000177560 915__ $$0StatID:(DE-HGF)0700$$2StatID$$aFees$$d2020-09-06
000177560 9201_ $$0I:(DE-He78)B340-20160331$$kB340$$lTranslationale Medizinische Onkologie$$x0
000177560 9201_ $$0I:(DE-He78)HD01-20160331$$kHD01$$lDKTK HD zentral$$x1
000177560 9201_ $$0I:(DE-He78)B330-20160331$$kB330$$lAngewandte Bioinformatik$$x2
000177560 9201_ $$0I:(DE-He78)BE01-20160331$$kBE01$$lDKTK BE zentral$$x3
000177560 9201_ $$0I:(DE-He78)FR01-20160331$$kFR01$$lDKTK FR zentral$$x4
000177560 9201_ $$0I:(DE-He78)FM01-20160331$$kFM01$$lDKTK FM zentral$$x5
000177560 9201_ $$0I:(DE-He78)MU01-20160331$$kMU01$$lDKTK MU LMU zentral$$x6
000177560 9201_ $$0I:(DE-He78)TU01-20160331$$kTU01$$lDKTK TU zentral$$x7
000177560 9201_ $$0I:(DE-He78)C110-20160331$$kC110$$lBewegung, Präventionsforschung und Krebs$$x8
000177560 9201_ $$0I:(DE-He78)C060-20160331$$kC060$$lC060 Biostatistik$$x9
000177560 980__ $$ajournal
000177560 980__ $$aVDB
000177560 980__ $$aI:(DE-He78)B340-20160331
000177560 980__ $$aI:(DE-He78)HD01-20160331
000177560 980__ $$aI:(DE-He78)B330-20160331
000177560 980__ $$aI:(DE-He78)BE01-20160331
000177560 980__ $$aI:(DE-He78)FR01-20160331
000177560 980__ $$aI:(DE-He78)FM01-20160331
000177560 980__ $$aI:(DE-He78)MU01-20160331
000177560 980__ $$aI:(DE-He78)TU01-20160331
000177560 980__ $$aI:(DE-He78)C110-20160331
000177560 980__ $$aI:(DE-He78)C060-20160331
000177560 980__ $$aUNRESTRICTED