A new approach to integrate toxicity grade and repeated treatment cycles in the analysis and reporting of phase i dose-finding trials

Annals of Oncology

Volumn 26, Issue 2, 2015, Pages 422-428

  Doussau, Adélaïde ^a,b,c,d,e   Thiebaut R ^c,d,e,f   Geoerger, B ^g,h   Schoffski P ^i,j   Floquet, A ^k   Le deley, M C ^g   Mathoulin Pelissier S ^e,k   Rizzo, E ^l   Fumoleau, P ^m   Le Tourneau, C ^a,b   Paoletti, X ^a,b  

^a INSTITUT CURIE   (France)

^b INSERM   (France)

^c Centre of Clinical Investigation Clinical Epidemiology   (France)

^d University Hospital   (France)

^e UNIVERSITÉ DE BORDEAUX   (France)

^f Labex Vaccine Research Institute   (France)

^g INSTITUT GUSTAVE ROUSSY   (France)

^h UNIVERSITÉ PARIS SACLAY   (France)

ⁱ UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^j UNIVERSITY OF LEUVEN   (Belgium)

^k INSTITUT BERGONIÉ   (France)

^l EORTC DATA CENTER   (Belgium)

^m CENTRE GEORGES FRANÇOIS LECLERC   (France)

more..

Author keywords

Cumulative toxicity; Dose finding trials; Dose limiting toxicity; Longitudinal studies; Phase I; Statistical analysis

Indexed keywords

AVISCUMINE; CYCLOPHOSPHAMIDE; DOXORUBICIN; ERLOTINIB; ANTINEOPLASTIC AGENT;

ADVERSE OUTCOME; ARTICLE; BRAIN STEM TUMOR; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; DISEASE SEVERITY; DISEASE SEVERITY ASSESSMENT; DRUG DOSE REGIMEN; GLIOMA; HUMAN; MAJOR CLINICAL STUDY; MEASUREMENT ACCURACY; MEASUREMENT PRECISION; OVARY CANCER; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROBABILITY; RETROSPECTIVE STUDY; SIDE EFFECT ASSESSMENT; SOLID TUMOR; TOXICITY; TREATMENT DURATION; FEMALE; MALE; MAXIMUM TOLERATED DOSE; NEOPLASMS; STANDARDS; STATISTICAL MODEL;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE I AS TOPIC; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MODELS, STATISTICAL; NEOPLASMS;

EID: 84925325802     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdu523     Document Type: Article

References (8)

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