CURRICULUM VITAE INFORMAZIONI PERSONALI TITOLO DI STUDIO E PROFESSIONALI ED ESPERIENZE LAVORATIVE

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1 CURRICULUM VITAE INFORMAZIONI PERSONALI Cognome Nome CRUDELE FEDERIKA Data di nascita 07/09/1967 Qualifica COLLABORATORE ESTERNO Amministrazione ISTITUTO NAZIONALE TUMORI DI NAPOLI Unita sperimentazioni cliniche Incarico attuale TRIAL MANAGER Numero telefonico dell ufficio Fax dell ufficio istituzionale TITOLO DI STUDIO E PROFESSIONALI ED ESPERIENZE LAVORATIVE Titolo di studio Altri titoli di studio e professionali Esperienze professionali (incarichi ricoperti) Maturità classica - dal 1996 ad oggi Trial manager presso la Struttura Complessa Sperimentazioni Cliniche dell Istituto Nazionale Tumori di Napoli Fondazione G. Pascale Capacità linguistiche Capacità nell uso delle tecnologie inglese Approfondita conoscenza nell utilizzo dei più diffusi sistemi operativi quali Microsoft Windows 2000/XP/VISTA/7. Elevata padronanza dell uso dei seguenti software, nelle più avanzate versioni: Microsoft Office (Word, Access, Excel, Power Point) e software compatibili con Microsoft Office con licenza Open Source e liberi. Elevata capacità di progettazione di database elettronici con i più diffusi software (Microsoft Access, MACRO [programma dedicato alla conduzione di sperimentazioni cliniche multicentriche con possibilità di remote loading dei dati]); approfondita conoscenza del sistema CRF.NET (suite di software per la gestione integrata delle sperimentazioni cliniche oncologiche via intranet/ internet). Elevata capacità di gestione di sistemi web complessi per la conduzione di sperimentazioni cliniche e la gestione di e-query connesse a procedure di monitoraggio centralizzato dei dati in sperimentazioni cliniche. Elevata capacità di allestimento di CRFs (Case Report Forms) in formato cartaceo ed elettronico per sperimentazioni cliniche. Competenza nell allestimento di SOP (Standard Operative Procedure) per la

2 conduzione di sperimentazioni cliniche. Altro (partecipazione a convegni e seminari, pubblicazioni, collaborazione a riviste, ecc., ed ogni altra informazione che il dirigente ritiene di dover pubblicare) PARTECIPAZIONI E ORGANIZZAZIOIA CORSI O CONVEGNI Corso Didattico AIOM Le sperimentazioni cliniche: ottimizzazione della conduzione pratica svoltosi nei giorni febbraio 2003 a Napoli Convegno NSCLC nel 2011: Presente e Futuro svoltosi il 25 maggio 2011 a Napoli Corso Programma di Training sulla Sperimentazione Clinica per Medici, Infermieri e Collaboratori dell Unità Clinica di Fase I svoltosi a Napoli nei giorni 13,14,15 Dicembre 2011 Corso Aspetti regolatori delle sperimentazioni cliniche svoltosi a Napoli nei giorni novembre 2012 Segreteria Organizzativa del convegno Epatocarcinoma: Attualità e prospettive svoltosi a Napoli il 19 giugno 1998 Segreteria Organizzativa del convegno Prevention, screening, prognosis and treatment of hepatocellular carcinoma svoltosi a Napoli nei giorni 5-6 giugno 2000 Segreteria Organizzativa del convegno Riunione di aggiornamento sul trattamento del carcinoma polmonare svoltosi a Napoli il giorno 19 aprile 2001 PRINCIPALI ATTIVITA ORGANIZZATIVE - progettazione delle schede raccolta dati (CRF cartacee ed elettroniche), allestimento e gestione dei database, raccolta dati e monitoraggio di circa 100 sperimentazioni cliniche. - segreteria organizzativa del gruppo CLIP (Cancer of the Liver Italian Project) si tratta del più ampio gruppo cooperativo Italiano sullo studio dell epatocarcinoma, che ha condotto studi clinici pubblicati su Lancet, Hepatology e altre riviste di rilievo. - segreteria organizzativa del più ampio gruppo cooperativo Italiano per lo studio dei tumori del polmone il gruppo, coordinato in collaborazione scientifica con il Dr. Gridelli, primario oncologo dell Ospedale di Avellino, vede la partecipazione di oltre 80 centri e ha prodotto numerose pubblicazioni su riviste di rilievo, tra cui ripetutamente il Journal of the National Cancer Institute, il Journal of Clinical Oncology e Lancet Oncology segreteria organizzativa del gruppo MITO per lo studio dei tumori ginecologici il gruppo, coordinato in collaborazione con il Dr. Pignata, oncologo dell Istituto Nazionale Tumori di Napoli e attuale Presidente del gruppo, vede la partecipazione di oltre 100 centri, collabora con altri gruppi cooperativi internazionali ed ha prodotto numerose pubblicazioni su riviste di rilievo, tra cui il Journal of Clinical Oncology e il British Journal of Cancer. PUBBLICAZIONI Qui di seguito vengono riportate le pubblicazioni in extenso in cui il ruolo di data-manager svolto dalla sottoscritta è esplicitato e testimoniato in prima pagina o nelle opportune sezioni (acknowledgments, appendix, etc ) 51. A. Morabito et al. Randomized phase III trial of gemcitabine and cisplatin vs. gem with advanced non-small cell lung cancer and performance statu study. Lung Cancer 2013 (in press)

3 50. Di Maio et al. Quality of Life Analysis of TORCH, a Randomized Trial Testing First-Line Followed by Second-Line Cisplatin/Gemcitabine Chemotherapy in Advanc Cell Lung Cancer. Journal Thoracic Oncology 2012 Dec;7(12): PubMed PMID 49. Gridelli et al. First-Line Erlotinib Followed by Second-Line Cisplatin-Gemcitabine Chem Advanced Non-Small-Cell Lung Cancer : The TORCH Randomized Trial Journal of Clinical Oncology 2012 Aug 20;30(24): doi: /JCO Epub 2012 Jul 9.PubMed PMID: F. Nuzzo et al. Bone effect of adjuvant tamoxifen, letrozole or letrozole plus zoledronic ac stage breast cancer : the randomized phase 3 HOBOE study Annal of Oncology doi: /annonc/mdr600, 12 March Massimo Di Maio et al Prognostic impact of education level of patients with advanced n lung cancer enrolled in clinical trials Lung Cancer 2012 Jun;76(3): Epub 2012 Jan 31. PubMed PMID 46. Gridelli et al. Phase I-II Trial of Gemcitabine-Based First-Line Chemotherapies for Sma Cancer in Elderly Patients with Performance Status 0-2. The G-Step Trial J Thorac Oncol Jan;7(1): PubMed PMID: S. Pignata et al. Carboplatin plus Paclitaxel versus Carboplatin plus Pegylated Liposomal first-line treatment for patients with ovarian cancer: the MITO-2 randomize Journal of Clinical Oncology 2011 Sep 20;29(27): Epub 2011 A PMID: G. De Feo et al. Time spent for Activation of Non-Profit Studies in oncology in Italy PlosOne July 2010, vol 5, issue 7, e G. Colucc et al. Randomized phase III trial of gemcitabine plus cisplatin compared to sing gemcitabine as first-line treatment of patientswith advanced pancreatic ca (Gruppo Italiano Pancreas GOIM/GISCAD/GOIRC) study. Journal of Clinical Oncology, vol. 28 n april 1; Cesare Gridelli et al. Cetuximab and gemcitabine in elderly or adult PS2 patients with advance lung-cancer: The cetuximab in advanced lung cancer (CALC1-E and CAL randomized phase II trias. Lung Cancer (2010) 67, 86-92; 41. C. Pisano, A.Morabito, et al. A phase II study of capecitabine in the treatment of ovarian cancer resista to platinum therapy: a multicentre Italian trial in ovarian cancer (MITO-6) t Cancer Chemotherapy Pharmacology (2009):64: DOI /s00

4 40. E.Rossi et al. Endocrine effects of adjuvant letrozole compared with tamoxifen in Hormo Responsive postmenopausal patients with early breast cancer: The HOBO J Clin Oncol, 2009 April 20; S. Pignata et al. Carboplatin and Pegylated Liposomal Doxorubicin for Advanced Ovarian Preliminary Activity Results of the MITO-2 Phase III Trial. Oncology 2009; 76: Gebbia V. et al. Weekly docetaxel vs. docetaxel-based combination chemotherapy as sec treatment of advanced non-small-cell lung cancer patients. The DISTAL-2 trial. Lung Cancer (2009) 63: G. De Feo et al. B88 : Impact of the ministerial decree December 21 st, 2007 on the time re multicentre clinical trials. Session B: supportive care Annals of oncology 20 (supplement 8); viii40, ottobre G. De Feo et al. P1* Time required to start multicentre clinical trials : a case study session Organization and pharmacoeconomic aspects, patient care and elderly Annals of Oncology 19 (supplement 9) 2008; ix 118-ix Gridelli C, et al. The MILES-2G phase 2 study of single-agent gemcitabinewith prolonged infusion in advanced non-small cell lung cancer elderly patients. Lung Cancer (2008) 61, Pignata S et al. A phase II study of weekly carboplatin and paclitaxel as first-line treatmen patients with advanced ovarian cancer. A multicenter Italian Trial in Ovari (MITO-5) study. Crit Rev Oncol Hematol 66: , E.Rossi et al. Endocrine effects of adjuvant letrozole plus triptorelin versus tamoxifen pl premenopausal patients with early breast cancer. J Clin Oncol, 2008 Jan 10; 26(2): Gridelli C et al. Cisplatin plus gemcitabine or vinorelbine for elderly patients with advance lung cancer: the MILES-2P studies. J Clin Oncol 25: , Gridelli C et al. Factorial phase III randomised trial of rofecoxib and prolonged constant in gemcitabine in advanced non-small-cell lung cancer: the GEmcitabine-CO (GECO) study. Lancet Oncol Jun;8(6):500-12

5 30. Di Maio M et al. Individual patient data meta-analysis of docetaxel administered once ever compared with once every week second-line treatment of advanced non-s cancer. J Clin Oncol Apr 10;25(11): De Maio E et al. Vinorelbine plus 3-weekly trastuzumab in metastatic breast cancer: a sing 2 trial. BMC Cancer Mar 20;7: Pignata S et al. Characteristics at presentation and outcome of hepatocellular carcinoma elderly. A study of the Cancer of the Liver Italian Program (CLIP). Crit Rev Oncol Hematol 2006 Sep;59(3): Pignata S et al. Safety of a 3-weekly schedule of carboplatin plus pegylated liposomal dox line chemotherapy in patients with ovarian cancer: preliminary results of th randomized trial (ClinicalTrials.gov Identifier: NCT ). BMC Cancer 2006 Aug 1;6(1): Pacilio C et al. Is epirubicin effective in first line chemotherapy of metastatic breast cance epirubicin-containing adjuvant treatment? A single centre phase III trial. Br J Cancer 2006 May 8;94 (9) : S. Pignata et al. Residual neurotoxicity in ovarian cancer patients in clinical remission afte chemotherapy with carboplatin and paclitaxel: The Multicenter Italian Tria cancer (MITO-4) retrospective study. BMC Cancer, 2006, Jan 7; 6:5 24. P. Maione et al. Pretreatment Quality of Life and Functional Status Assessment Significan Survival of Elderly Patients With Advanced Non-Small-Cell Lung Cancer R Chemotherapy: A Prognostic Analysis of the Multicenter Italian Lung Can Elderly Study. Journal of Clinical Oncology, 2005, 23: M. Di Maio et al. Chemotherapy-induced neutropenia and treatment efficacy in advanced n lung cancer: a pooled analysis of three randomized trials. Lancet Oncology 2005,6: E. De Maio et al. Compliance and toxicity of adjuvant CMF in elderly breast cancer patients experience.bio Med Central Cancer 2004, 5: F. Perrone et al. Outcome of Patients With a Performance Status 2 in the Multicenter Italia in the Elderly Study (MILES). Journal of Clinical Oncology, 2004, Dec 15;22(24): ;

6 20. C.Gridelli et al. A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) i line treatment of non-small-cell lung cancer. The DISTAL 01 study. British Journal of Cancer 2004, Dec 13;91(12): S.De Placido et al. Topotecan compared with no therapy after response to surgery and Carboplatin/Paclitaxel in patients with ovarian cancer. The MITO-1 (Multic Trials in Ovarian cancer) randomized study. Journal of Clinical Oncology 2004, 22: M.DiMaio et al. Prevalence and management of pain in Italian patients with advanced non cancer. British Journal of Cancer 2004, 90: M.DiMaio et al. Supportive care in patients with advanced non-small-cell lung cancer. British Journal of Cancer, 2003, 89: C.Gridelli et al. Gemcitabine plus vinorelbine compared to cisplatin plus vinorelbine or cis gemcitabine for advanced non-small-cell lung cancer. A phase III trial of th GEMVIN Investigators and the National Cancer Institute of Canada - Clini Group. Journal of Clinical Oncology, 2003, 21: Epub 2003 July F.Perrone et al. Statistical design in phase II clinical trials and their application in breast ca Lancet Oncology, 2003, 4: B.Daniele et al. First-Line Chemotherapy With Fluorouracil and Folinic Acid for Advanced Cancer in Elderly Patients. A Phase II Study. Journal of Clinical Gastroenterology, 2003;36: C.Gridelli et al. Chemotherapy for elderly patients with advanced non-small cell lung canc (Multicenter Italian Lung cancer in the Elderly Study) phase 3 randomized Journal of the National Cancer Institute, 2003, 95: B.Daniele et al. Hepatic resection and percutaneous ethanol injection as treatments of sm hepatocellular carcinoma. A Cancer of the Liver Italian Program (CLIP 08 case-control study. Journal of Clinical Gastroenterology, 2003, 36: A.deMatteis et al. Docetaxel plus Epidoxorubicin as neoadjuvant treatment of large operable advanced breast cancer. A single-center phase II study. Cancer, 2002,feb 15; 94(4); C.Gridelli, et al. Carboplatin plus vinorelbine plus G-CSF support in elderly patients with e small-cell lung cancer: a poorly tolerated regimen. Results of a multicentre Lung Cancer, 2002, 36:

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