Clinical trials coordinating center

ITT Core Research Laboratory (CRL)

c/o Department of Oncology (Padiglione 17 - San Damiano)
Azienda Ospedaliero Universitaria Careggi (AOU Careggi)
Via delle Oblate 1 - 50141 Firenze
Tel: 055-7947553
Fax: 055-7947553

Principal investigator: Luca Boni, Epidemiologist

Team members
Elisa Bianchini statistician
Michele Andreuccetti clinical trials administrator
Daniela Baldari clinical trials administrator
Sandra Biancanelli clinical trials administrator

Introduction

The Clinical Trials Coordinating Center (CTCC), a Research Unit of the CRL of the Istituto Toscano Tumori (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 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

  • Cancer - prevention, detection, treatment and outcomes
  • Stopping rules in clinical trials
  • Bayesian approach to clinical trials
  • New designs for phase I clinical trials

Clinical trials

Description Year Sponsor Number of patients
recruited to date
High-Intensity Focused Ultrasound (HIFU) in association with surgery and chemotherapy in patients with operable breast cancer Planning phase AUSL 7 Siena 0
Clinical activity of DNA damaging and nondamaging chemotherapy regimens in advanced breast cancer patients with different biological sub-types defined by biomarker evaluation on circulating tumor cells Planning phase AUSL 4 Prato 0
Multicenter phase III randomized study of cisplatin and etoposide with or without bevacizumab as first-line treatment in extensive stage small-cell lung cancer 2009 Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC) and Agenzia Italiana del Farmaco (AIFA) 6
Phase II study of cetuximab in combination with cisplatin-docetaxel in the first-line treatment of patients with advanced NSCLC: a biomarkerbased assessment of activity. Protocol GOIRC 03/2008 2009 GOIRC 3
Phase II randomized trial of an oral chemotherapy combination of capecitabine + vinorelbine and their sequential single agent use in metastatic breast cancer 2009 GOIRC 3
Randomised placebo controlled phase III study with low doses of tamoxifen in women with intraepithelial neoplasia of the breast 2008 Ente Ospedaliero Ospedali "Galliera" 20
A phase III randomized trial of FOLFOXIRI + bevacizumab versus FOLFIRI + bevacizumab as first-line treatment for metastatic colorectal cancer 2008 Gruppo Oncologico del Nord Ovest (GONO) 240
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 2008 GONO 70
Randomized phase II study of pemetrexed versus pemetrexed and carboplatin as second line chemotherapy in advanced Non-Small Cell Lung Cancer (NSCLC) 2007 GOIRC 241
A multicenter randomized phase III study: 5-fluorouracile versus 5-fluorouracile + oxaliplatin in combination with pelvic radiotherapy as preoperative treatment of resectable, locally-advanced rectal cancer 2003 University of Pisa 752
A randomized phase III multicenter study: prevention of chemotherapy-induced menopause by temporary ovarian suppression with triptorelin versus controls in young breast cancer patients 2003 Istituto Nazionale per la Ricerca sul Cancro (IST) 282

Research grants

Year Funding Agency Amount
2009 GlaxoSmithKline € 15,000
2009 University of Modena € 25,000

Main collaborations

With units within ITT

  • University of Florence
  • Azienda Ospedaliero Universitaria Pisana

With other Italian and foreign units

  • Istituto Nazionale per la Ricerca sul Cancro (IST), Genova
  • Ente Ospedaliero Ospedali "Galliera", Genova
  • University of Genoa
  • Istituto Giannina Gaslini, Ospedale Pediatrico, Genova
  • GOIRC
  • GONO

Publications

  1. De Bernardi B, Gerrard M, Boni L, et al: Excellent outcome with reduced treatment for infants with disseminated neuroblastoma without MYCN gene amplification. J Clin Oncol 2009; 27: 1034-40.
  2. Regge D, Laudi C, Galatola G, et al: Diagnostic accuracy of computed tomographic colonography for the detection of advanced neoplasia in individuals at increased risk of colorectal cancer. JAMA 2009; 301: 2453-61.
  3. Vasile E, Masi L, Fornaro G, et al: A multicenter phase II study of the combination of oxaliplatin, irinotecan and capecitabine in the first-line treatment of metastatic colorectal cancer. Br J Cancer 2009; 100: 1720-4.
  4. Masi G, Loupakis F, Pollina L, et al: Long-term outcome of initially unresectable metastatic colorectal cancer patients treated with 5-fluorouracil/leucovorin, oxaliplatin and irinotecan (FOLFOXIRI) followed by radical surgery of metastases. Ann Surg 2009; 249: 420-5.
  5. Tiseo M, Capelletti M, De Palma G, et al: Epidermal growth factor receptor intron-1 polymorphism predicts gefitinib outcome in advanced non-small cell lung cancer. J Thorac Oncol 2008; 3: 1104-11.
  6. Tibaldi C, Vasile E, Bernardini I, Orlandini C, Andreuccetti M, Falcone A: Baseline elevated leukocyte count in peripheral blood is associated with poor survival in patients with advanced non-small cell lung cancer: a prognostic model. J Cancer Res Clin Oncol 2008; 134: 1143-9.
  7. Tibaldi C, Vasile E, Antonuzzo A, et al: First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study. Br J Cancer 2008; 98: 558-63.
  8. Ardizzoni A, Boni L, Tiseo M, et al: 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; 99: 847-57.
  9. Falcone A, Ricci S, Brunetti I, et al: Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: The Gruppo Oncologico Nord-Ovest (GONO). J Clin Oncol 2007; 13: 1670-6.
  10. Del Mastro L, Catzeddu T, Boni L, et al: Prevention of chemotherapy-induced menopause by temporary ovarian suppression with goserelin in young, early breast cancer patients. Ann Oncol 2006; 17: 74-8.
  11. Miglietta L, Franzone P, Centurioni MG, 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 2006; 70: 19-24.
  12. Benasso M, Ponzanelli A, Merlano M, et al: 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 2006; 45: 168-74.
  13. Masi G, Marcucci L, Loupakis F, et al: First-line 5-fluorouracil/folinic acid, oxaliplatin and irinotecan (FOLFOXIRI) does not impair the feasibility and the activity of second line treatments in metastatic colorectal cancer. Ann Oncol 2006; 17:1249-54.
  14. 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 (FONICAPGSTPV) study. J Clin Oncol 2005; 23: 569-75.
  15. Lanciotti M, Coco S, Michele PD, et al: Glutathione S-transferase polymorphisms and susceptibility to neuroblastoma. Pharmacogenet Genomics 2005; 15: 423-6.
  16. London WB, Boni L, Simon T, et al: The role of age in neuroblastoma risk stratification: the German, Italian, and children's oncology group perspectives. Cancer Lett 2005; 228: 257-66.
  17. 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 2005; 23: 6276-7.
  18. 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 2003; 52: 116-20.
  19. 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 2003; 21: 1592-1601.
  20. 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 2003; 22:359-65.
  21. Romani M, Tonini GP, Banelli B, et al: Biological and clinical role of p73 in neuroblastoma. Cancer Lett 2003; 197: 111-7.
  22. Garaventa A, Luksch R, Lo Piccolo MS, et al: Phase I trial and pharmacokinetics of fenretinide in children with neuroblastoma. Clin Cancer Res 2003; 9: 2032-9.
  23. Grossi F, Loprevite M, Chiaramondia M, et al: Prognostic significance of K-ras, p53, bcl-2, PCNA, CD34 in radically resected non-small cell lung cancers. Eur J Cancer 2003; 39: 1242-50.
  24. 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 2002; 9: 246-51.
  25. Garaventa A, Boni L, Lo Piccolo MS, et al: Localized unresectable neuroblastoma: results of treatment based on clinical prognostic factors. Ann Oncol 2002; 13: 956-64.
  26. Baldini E, Ardizzoni A, Prochilo T, et al: 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 2001; 85: 1452-5.

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