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Clinical Trials Coordinating Center

c/o Department of Oncology
AOU Careggi - Padiglione 17 San Damiano
Viale Pieraccini, 17
50139 FIRENZE
Phone: +39 055 7947553
luca.boni@ittumori.it

Principal Investigator: Dr. Luca Boni

The Clinical Trials Coordinating Center (CTCC), a research unit of the Core Research Laboratory of the Tumour Institute of Tuscany (ITT), operates to promote multi-institutional independent research through the development, management, and reporting of hypothesis-driven clinical trials.

For each trial, the CTCC provides to the oncological network of Tuscany comprehensive services that include:

  • developing protocols, forms, and manuals of operations
  • designing web-based randomization
  • implementing trial management and web-based data gathering systems
  • providing training
  • recruiting investigators and centers
  • monitoring recruitment
  • conducting reviews and evaluations
  • monitoring adverse effects and events
  • maintaining data bases and analyzing data
  • assuring quality control
  • providing annual and interim reports
  • collecting final data and producing final data sets and final reports
  • overseeing regulatory compliance
  • monitoring vital status
  • disseminating study information

Main Research Themes

  1. Cancer - prevention, detection, treatment and outcomes
  2. Stopping rules in clinical trials
  3. Bayesian approach to clinical trials
  4. New designs for phase I clinical trials

Clinical Trials

  • Prevention of Chemotherapy-induced Menopause by Temporary Ovarian Suppression with Triptorelin vs. Control in Young Breast Cancer Patients. A Randomized Phase III Multicenter Study. Promise Protocol.
  • 5-fluorouracile vs. 5-fluorouracile + Oxaliplatin in combination with pelvic radiotherapy as pre-operative treatment of resectable, locally-advanced rectal cancer: a multicenter randomized phase III study. STAR Protocol.
  • Randomized phase II study of pemetrexed versus pemetrexed and carboplatin as second line chemotherapy in advanced non-small-cell lung cancer (NSCLC) – GOIRC 02/2006.
  • An open-label, multicenter, randomized phase III study of second-line chemotherapy with or without bevacizumab in metastatic colorectal cancer patients who have received first-line chemotherapy plus bevacizumab. Bepyp Protocol.
  • A phase III randomized trial of folfoxiri + bevacizumab versus folfiri + bevacizumab as first-line treatment for metastatic colorectal cancer. Tribe Protocol.
  • Studio randomizzato placebo controllato di fase III con tamoxifen a basse dosi in donne con neoplasia intraepiteliale della mammella. Protocollo TAM-01.
  • Valutazione dell'Efficacia della Vinorelbina in sostituzione al Platino e dell’aggiunta di Ifosfamide ad un Regime Chemioterapico a due Farmaci in Pazienti con Carcinoma Polmonare non a Piccole Cellule in Stadio Avanzato o Metastatico: Studio Clinico Prospettico, Fattoriale, Multicentrico, Randomizzato, di Fase III. Protocollo FAST.
  • Studio di confronto per valutare l’efficacia e la tollerabilità di una nuova combinazione a dosaggio fisso di Glibenclamide (2,5 mg) + Metformina (850 mg) verso una combinazione standard a dosaggio fisso di Glibenclamide (2,5 mg) + Metformina (400 mg), verso monoterapia a base di Glibenclamide (5 mg) e verso monoterapia a base di Metformina (850 mg), nel trattamento del diabete di tipo 2. Studio GUID/02/Glm-Dia/001.
  • Randomized phase II trial of two sequential schedules of docetaxel and cisplatin followed by gemcitabine in patients with advanced non-small-cell lung cancer. XRP6976B/2506 Protocol.
  • Evaluation of accuracy of computerised tomography-colonography (CTC) as a test for surveillance in subjects at increased risk of colorectal carcinoma: a multicentre study. IMPACT Study.

Publications

  1. Baldini E, Ardizzoni A, Prochilo T, Cafferata M, Boni L, Tibaldi C, Neumaier C, Conte P, Rosso R. Gemcitabine, ifosfamide and navelbine (GIN): activity and safety of a non platinum based triplet in advanced non small cell lung cancer (NSCLC). Br. J. Cancer, 85, 1452-1455, 2001
  2. Casciano I, Mazzocco K, Boni L et al. Expression of DNp73 is a molecular marker for adverse outcome in neuroblastoma patients. Cell Death and Differentiation, 9, 246 251, 2002
  3. Garaventa A, Boni L, Lo Piccolo MS et al. Localized unresectable neuroblastoma: results of treatment based on clinical prognostic factors. Annals of Oncology, 13, 956-964, 2002
  4. Gambini C, Sementa AR, Boni L et al. Expression of HER2/neu is uncommon in human neuroblastic tumors and is unrelated to tumor progression Cancer Immunol Immunother., 52(2), 116-120, 2003.
  5. De Bernardi B, Nicolas B, Boni L et al. Disseminated neuroblastoma in children older than one year at diagnosis: comparable results with three consecutive high-dose protocols adopted by the italian co-operative group for neuroblastoma (ICGNB). J Clin Oncol., 21(8), 1592-1601, 2003.
  6. Castagnola E, Boni L, Giacchino M et al. A multicenter, randomized, double blind placebo - controlled trial of amoxicillin / clavulanate for the prophylaxis of fever and infection in neutropenic children with cancer. Pediatr Infect Dis J., 22(4), 359-365, 2003.
  7. Costantini M, Higginson IJ, Boni L et al. Effect of a palliative home care team on hospital admissions among patients with advanced cancer. Palliative Medicine, 17, 315-321, 2003.
  8. Romani M, Tonini GP, Banelli B, Alemanni G, Mazzocco K, Scaruffi P, Boni L et al. Biological and clinical role of p73 in neuroblastoma. Cancer Lett., 18, 197(1-2):111-7, 2003. Review.
  9. Garaventa A, Luksch R, Lo Piccolo MS, Cavadini E, Montaldo PG, Pizzitola MR, Boni L et al. Phase I trial and pharmacokinetics of fenretinide in children with neuroblastoma. Clin Cancer Res., 9(6):2032-9, 2003.
  10. Grossi F, Loprevite M, Chiaramondia M, Ceppa P, Pera C, Ratto GB, Serrano J, Ferrara GB, Costa R, Boni L, Ardizzoni A. Prognostic significance of K-ras, p53, bcl-2, PCNA, CD34 in radically resected non-small cell lung cancers. Eur J Cancer, 39(9):1242-50, 2003.
  11. Ardizzoni A, Favaretto A, Boni L et al. Platinum-etoposide chemotherapy in elderly patients with small-cell lung cancer: results of a randomized multicenter phase II study assessing attenuated-dose or full-dose with lenograstim prophylaxis--a Forza Operativa Nazionale Italiana Carcinoma Polmonare and Gruppo Studio Tumori Polmonari Veneto (FONICAP-GSTPV) study. J Clin Oncol., 23(3):569-75, 2005.
  12. Lanciotti M, Coco S, Michele PD, Haupt R, Boni L et al. Glutathione S-transferase polymorphisms and susceptibility to neuroblastoma. Pharmacogenet Genomics, 15(6):423-426, 2005.
  13. London WB, Boni L, Simon T, Berthold F, Twist C, Schmidt ML, Castleberry RP, Matthay KK, Cohn SL, De Bernardi B. The role of age in neuroblastoma risk stratification: the German, Italian, and children's oncology group perspectives. Cancer Lett. 228(1-2):257-66, 2005.
  14. Tiseo M, Boni L, Ardizzoni A. Platinum-based versus non-platinum-based chemotherapy in advanced non-small-cell lung cancer: does cisplatin versus carboplatin make a difference ? J Clin Oncol. 23(25):6276-7, 2005.
  15. Del Mastro L, Catzeddu T, Boni L, Bell C, Sertoli MR, Bighin C, Clavarezza M, Testa D, Venturini M. Prevention of chemotherapy-induced menopause by temporary ovarian suppression with goserelin in young, early breast cancer patients. Ann Oncol. 17(1):74-8, 2006.
  16. Miglietta L, Franzone P, Centurioni MG, Boni L et al. A phase II trial with cisplatin/paclitaxel cytotoxic treatment and concurrent external and endocavitary radiation therapy in locally advanced or recurrent cervical cancer. Oncology 70:19-24, 2006.
  17. Benasso M, Ponzanelli A, Merlano M, Numico G, Ricci I, Vigo V, Grossi F, Amadori D, Cavallo G, Capaccetti B, Taveggia P, Boni L, Rosso R. Paclitaxel, cisplatin and 5-fluorouracil in recurrent squamous cell carcinoma of the head and neck: a phase II trial from an Italian cooperative group. Acta Oncol. 45(2):168-74, 2006.
  18. Catania G, Costantini M, Lambert A, Luzzani M, Marceca F, Tridello G, Boni L, Bernardi M. [Testing an instrument measuring Italian nurses' knowledge and attitudes regarding pain] Assist Inferm Ric. 2006 Jul-Sep;25(3):149-56. Italian.
  19. Tarantini G, Scrutinio D, Bruzzi P, Boni L, Rizzon P, Iliceto S. Metabolic Treatment with L-Carnitine in Acute Anterior ST Segment Elevation Myocardial Infarction. A Randomized Controlled Trial. Cardiology. 2006;106(4):215-23. Epub 2006 May 9.
  20. Ardizzoni A, Boni L, Tiseo M, Fossella FV, Schiller JH, Paesmans M, Radosavljevic D, Paccagnella A, Zatloukal P, Mazzanti P, Bisset D, Rosell R Cisplatin- versus carboplatin-based chemotherapy in first-line treatment of advanced non-small-cell lung cancer: an individual patient data meta-analysis. J Natl Cancer Inst. 2007 Jun 6;99(11):847-57.
  21. Catania G, Poirè I, Dozin B, Bernardi M, Boni L. Validating a measure to delineate the clinical trials nursing role in Italy. Cancer Nurs. 2008 Sep-Oct;31(5):E11-5.
  22. Tiseo M, Capelletti M, De Palma G, Franciosi V, Cavazzoni A, Mozzoni P, Alfieri RR, Goldoni M, Galetti M, Bortesi B, Bozzetti C, Loprevite M, Boni L, Camisa R, Rindi G, Petronini PG, Ardizzoni A. Epidermal growth factor receptor intron-1 polymorphism predicts gefitinib outcome in advanced non-small cell lung cancer. J Thorac Oncol. 2008 Oct;3(10):1104-11.
  23. De Bernardi B, Gerrard M, Boni L, Rubie H, Cañete A, Di Cataldo A, Castel V, Forjaz de Lacerda A, Ladenstein R, Storm-Mathisen I, Brichard B, Couturier J, Ellershaw C, Munzer C, Bruzzi P, Michon J and Pearson ADJ. Excellent Outcome With Reduced Treatment For Infants With Disseminated Neuroblastoma Without MYCN Gene Amplification. Results Of Two Siopen Studies. J Clin Oncol (in press).

Collaborations

  • Università degli Studi (Firenze)
  • GONO - Gruppo Oncologico del Nord-Ovest
  • GOIRC - Gruppo Oncologico Italiano di Ricerca Clinica
  • Istituto Nazionale per la Ricerca sul Cancro (Genova)
  • Azienda Ospedaliero Universitaria Pisana (Pisa)
  • Ente Ospedaliero Ospedali Galliera (Genova)
  • Institute for Cancer Research and Treatment (Candiolo)
  • Università degli Studi (Genova)
  • Istituto Giannina Gaslini – Ospedale Pediatrico IRCCS (Genova)

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