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CURRICULUM VITAE INFORMAZIONI PERSONALI
Cognome Nome
Data di nascita
Qualifica
Amministrazione
Incarico attuale
CRUDELE FEDERIKA
07/09/1967
COLLABORATORE ESTERNO
ISTITUTO NAZIONALE TUMORI DI NAPOLI – Unita’ sperimentazioni
cliniche
TRIAL MANAGER
Numero telefonico dell’ufficio
0815903571
Fax dell’ufficio
0817702938
E-mail istituzionale
[email protected]
TITOLO DI STUDIO E PROFESSIONALI ED ESPERIENZE LAVORATIVE Titolo di studio
Maturità classica
Altri titoli di studio e professionali
Esperienze professionali
(incarichi ricoperti)
Capacità linguistiche
Capacità nell’uso delle
tecnologie
- dal 1996 ad oggi
Trial manager presso la Struttura
Complessa
Sperimentazioni Cliniche dell’Istituto Nazionale
Tumori di Napoli “Fondazione G. Pascale”
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
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 27-28 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 26-27 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)
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):1830-1844. 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):3002-11. doi:
10.1200/JCO.2011.41.2056. Epub 2012 Jul 9.PubMed PMID: 22778317.
48.
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:10.1093/annonc/mdr600,
47.
12 March 2012
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):457-64. 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. 2012 Jan;7(1):233-42. PubMed PMID: 22031232
45.
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):3628-35.Epub 2011 A
PMID: 21844495.
44.
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 11864
43.
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.10 2010 april 1; 1645- 1651
42.
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: 1021-27 DOI 10.1007/s00
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; 1-9
39.
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: 49-54
38.
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: 251-258
37.
G. De Feo et al.
B88 : Impact of the ministerial decree December 21st , 2007 on the time re
multicentre clinical trials. Session B: supportive care
Annals of oncology 20 (supplement 8); viii40, ottobre 2008
36.
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 132
35.
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, 67-72
34.
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: 229-236, 2008
33.
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):1-7
32.
Gridelli C et al.
Cisplatin plus gemcitabine or vinorelbine for elderly patients with advance
lung cancer: the MILES-2P studies.
J Clin Oncol 25: 4663-4669, 2007
31.
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. 2007 Jun;8(6):500-12
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. 2007 Apr 10;25(11):1377-82
29.
De Maio E et al.
Vinorelbine plus 3-weekly trastuzumab in metastatic breast cancer: a sing
2 trial.
BMC Cancer. 2007 Mar 20;7:50
28.
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):243-9
27.
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: NCT00326456).
BMC Cancer 2006 Aug 1;6(1): 202
26.
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) : 1233-6
25.
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: 6865-6872
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 2005,6:669-77
22.
E. De Maio et al.
Compliance and toxicity of adjuvant CMF in elderly breast cancer patients
experience
.Bio Med Central Cancer 2004, 5:30
21.
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):5018-20;
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):1996-2004.
19.
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: 2635-2642.
18.
M.DiMaio et al.
Prevalence and management of pain in Italian patients with advanced non
cancer.
British Journal of Cancer 2004, 90: 2288-2296.
17.
M.DiMaio et al.
Supportive care in patients with advanced non-small-cell lung cancer.
British Journal of Cancer, 2003, 89:1013-1021.
16.
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, 21:3025-34. Epub 2003 July 01.
15.
F.Perrone et al.
Statistical design in phase II clinical trials and their application in breast ca
Lancet Oncology, 2003, 4:305–11.
14.
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;36:228–233.
13.
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, 95:362-372.
12.
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: 63–67.
11.
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); 895-901.
10.
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: 327-32.
9.
F.Perrone et al.
Tamoxifen in the treatment of hepatocellular carcinoma: 5-year results of
multicentre randomised controlled trial.
Current Pharmaceutical Design, 2002;8: 99-110.
8.
F. Perrone et al.
Survey of modalities of toxicity assessment and reporting in non-compara
studies of chemotherapy in breast cancer.
Journal of Clinical Oncology, 2002, 20: 52-57.
7.
R.Parasole et al.
Prognostic value of serum biological markers in patients with hepatocellul
Clinical Cancer Research, 2001, 7: 3504-3509
6.
C.Gridelli et al.
Carboplatin + epirubucin + VP-16 + Lenograstim followed by radiotherapy
as radiosensitizer in localized small cell lung cancer. A multicenter phase
Anticancer Research, 2001 21:4179-4184.
5.
C.Gridelli et al.
Activity and toxicity of gemcitabine and gemcitabine + vinorelbine in adva
cell lung cancer elderly patients. Phase II data from the MILES (Multicente
cancer in the Elderly Study) randomized trial.
Lung cancer, 2001, 31:277-284.
4.
C.Gridelli et al.
Carboplatin plus paclitaxel in extensive small cell lung cancer: a multicent
study.
British Journal of Cancer, 2001, 84:38-41.
3.
C. Gridelli et al.
Gemcitabine plus vinorelbine in advanced non-small cell lung cancer:a ph
three different doses.
British Journal of Cancer, 2000, 83(6), 707-714
2.
C.Gridelli et al.
Effects of vinorelbine on quality of life and survival of elderly patients with
small-cell lung cancer.
Journal of the National Cancer Institute, 91: 66-72, 1999.
1.
C.Gallo et al.
Tamoxifen in the treatment of hepatocellular carcinoma: a multicenter ran
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The Lancet, 352:17-20, 1998.