Algunos de estas aportaciones desde una perspectiva de complejidad las encontramos en:
ESTRATEGIAS, RECURSOS
2. Justificación y discusión del problema
2.2 Justificación y discusión externa
28/04 Open label randomized, multicenter phase III study of adjuvant chemotherapy in radically resected adenocarcinoma of the stomach or gastroesophageal junction: comparison of sequential treatment (CPT11 + 5-FU/LV TXT + CDDP versus a 5-FU/LV regimen)
M. Di Bartolomeo
2005 21/01/13 III 71 Closed
accrual
54/06 Phase III, randomised, double-blind, stratified, comparative, placebo controlled, parallel group, multicentre study to assess the effect of deep subcutaneous injections of lanreotide autogel 120 mg administered every 28 days on tumour progression free survival in patients with non functioning entero-pancreatic endocrine tumour.
R. Buzzoni 2006 19/09/13 III 1 Closed
accrual
25/07 A study of the genetic polymorphisms of patients with gastrointestinal stromal tumors (GIST) and of their predictive value of clinical activity of tyrosin kinase inhibitors
P. Casali 2007 30/01/13 Observational 36 Closed accrual
Study Code
Title Coordinator Activated Closed Phase Total
patients
Patients enrolled in 2013 32/07 The Global Observational registry colllecting
Longitudinal Data on Advanced GIST patients (GOLD reGISTry)
P. Casali 2007 25/02/13 Observational 54 Closed accrual
69/07 A double-blind, randomised, multicenter, phase III study of bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin, as first- line therapy in patients with advanced gastric cancer
M. Di Bartolomeo
2007 22/01/13 III 9 Closed
accrual
17/04 A phase II, open label study of PTK787/ZK222584 in the treatment of metastatic Gastrointestinal Stromal Tumors (GISTs) resistant to imatinib mesylate
P. Casali 2005 II 22 Closed
accrual
75/06 A prospective randomized, open-label trial comparing Sirolimus-containing versus mTOR -inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma.
V. Mazzaferro
2006 II 39 Closed
accrual
09/07 LIVER MATCH. An Italian multicentric study to evaluate the impact of donor-recipient matching in the outcome of liver transplantation at short, medium and long term
E. Regalia 2007 - 54 Closed
accrual
08/08 Accrual of patients with colorectal cancer and of healthy sisters/brothers for studies on genetic risk factors
T. Dragani 2008 15/10/13 - 1258 106
52/07 A randomized trial investigating the role of FOLFOX-4 regimen duration (3 versus 6 months) and bevacizumab as adjuvant therapy for patients with stage II/III colon cancer
M. Di Bartolomeo
2007 III 131 Closed
accrual
27/08 Perioperative treatment with COI-E (capecetabine, oxaliplatin, irinotecan and cetuximab) of liver metastasis of colorectal carcinoma potentially resectable although at high risk of recurrences
R. Buzzoni 2008 II 34 6
38/08 A phase III randomized, double-blind, placebo- controlled study of sorafenib as adjuvant treatment for hepatocellular carcinoma after surgical resection or local ablation (STORM)
V. Mazzaferro
2008 III 46 Closed
accrual
01/09 Open label extension study of lanreotide autogel 120 mg in patients with non functioning entero- pancreatic endocrine tumour
R. Buzzoni 2009 III 1 Closed
accrual
21/09 A randomized, open-label, multicenter phase III study to evaluate the efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors
P. Casali 2009 III 1 Closed
accrual
12/09 Capecetabine in combination with oxaliplatin, irinotecan and bevacizumab (COI-B regime) as first. line therapy for metastatic colorectal cancer: a phase II ITMO study
M. Di Bartolomeo
2009 26/06/13 II 33 Closed
accrual
24/09 A randomized, double-blind, multicenter phase III study of brivanib plus best supportive care (BSC) versus placebo plus BSC in subjects with advanced hepatocellular carcinoma (HCC) who have failed or
V. Mazzaferro
2009 17/05/13 III 6 Closed
Study Code
Title Coordinator Activated Closed Phase Total
patients
Patients enrolled in 2013 79/09 Observational study of plasma levels of Imatinib in
patients with gastrointestinal stromal tumor
P. Casali 2010 Observational 80 7
80/09 Controlled extension of conventional criteria for liver tranplantation in hepatocellular carcinoma (HCC): a prospective validation study
V. Mazzaferro
2009 II 32 7
21/10 A phase II, open label study to evaluate the activity and safety of Everolimus in association to Imatinib in PDGFRA-D842V unresectable or metastatic gastrointestinal stromal tumours (GISTs) as first line treatment
P. Casali 2010 II 5 2
80/10 A randomized, double-blind, placebo-controlled phase III of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib
P. Casali 2011 III 10 Closed
accrual
14/11 ITACA-S- 2 (Intergroup trial in adjuvant
chemotherapy for adenocarcinoma of the stomach) comparison of the efficacy of a peri-operative versus a post-operative chemotherapy treatment in patients with operable gastriic cancer and assessment of the benefit op a post-operative chemo-radiotherapy
R. Buzzoni 2011 III 1 Closed
accrual
30/11 Phase 2 placebo-controlled double-blind trial of dasatinib added to gemcitabinae for subjects with locally-advanced pancreatic cancer
R. Buzzoni 2011 II 5 Closed
accrual
75/11 DOVIGIST: Phase II trial to evaluate the efficacy and safety of Dovitinib (TKI258) in patients with gastrointestinal stromal tumors refractory and/or intolerant to imatinib
P. Casali 2011 II 3 Closed
accrual
85/11 Phase I dose escalation study of S. 78454 (HDACi) in combination with FOLFOX in patients with locally advanced or metastatic digestive cancer
F. de Braud 2011 I 8 2
94/11 Evaluation of diagnostic accuracy of diffusion- weighted magnetic resonance (DW-MRI) and perfusion magnetic resonance (DCE-MRI) in the dilation of mesorectal lymph nodes in colorectal cancer
D. Scaramuzza
2011 Observational 32 0
100/11 A randomized, open-label, multicenter phase IIIb study comparing two trastuzumab dosing regimens, each in combination with cisplatin/capecitabine chemotherapy, as first-line therapy in patients with HER 2-positive metastatic gastric or gastro- esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease
M. Di Bartolomeo
2011 III 7 1
06/12 Efficacy of tandem treatment with [90Y-DOTA, Tyr(3)] Octreotate and [177LuDOTA, Tyr(3)] Octreotate in patients with neuroendocrine tumour overexpressing somatostatin receptors and refractory to conventional therapy
Study Code
Title Coordinator Activated Closed Phase Total
patients
Patients enrolled in 2013 15/12 Pseudomixoma peritonei: prognostic analysis of
micro-RNA and other factors using tissue
M. Deraco 2012 Observational 24 11
16/12 Multicenter Italian study on the CEUS assessment of Response of colorectal cancer metastasis Treated with Avastin
R. Lanocita 2012 IV 2 0
22/12 A randomized, double-blind, multicenter, Phase III study of everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in the treatment of patients with advanced NET of GI or lung origin - RADIANT-4
R. Buzzoni 2012 III 23 Closed
accrual
31/12 Peritoneal Mesothelioma: Optimize Outcomes by the Integration of new Prognostic Factors and Potential Therapeutic Targets in a Individualized Treatment based on Molecular Characterization and Chemosensitivity Profile on Primary Cultures
M. Deraco 2012 II 16 12
42/12 A multi-center, open-label study to assess pharmacokinetics of TKI258 in adult cancer patients with normal and impaired hepatic function
F. de Braud 2012 I 8 2
60/12 "A Randomized, Open-label, Two-Arm Phase II Trial Comparing the Efficacy of Sequential Ipilimumab versus Best Supportive Care Following First-line Chemotherapy in Subjects with Unresectable Locally Advanced/Metastatic Gastric or Gastro- Esophageal Junction Cancer”
Maria Di Bartolomeo
2012 II 16 8
73/12 Identification of circulating tumor cells in blood of patients with advanced colorectal cancer and assessment of their modifications during treatment with cetuximab or panitumumab, alone or associated with chemotherapy
F. de Braud 2012 Observational 52 25
74/12 A Multicenter, Single arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients with Metastatic Colorectal Cancer (mCRC) Previously Treated with an Oxaliplatin-Containing Regimen
Maria Di Bartolomeo
2012 III 15 Closed
Accrual
97/12 A randomized, phase III, multicenter, double- blid, placebo-controlled study evaluating the efficacy and safety of onartuzumab (MetMab) in combination with metastatic HER2 negative, MET- Positive Gastriesophageal cancer
Maria Di Bartolomeo
2012 III 18 17
99/12 An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy
M. Di Bartolomeo
2013 III 15 Closed
accrual
102/12 A multicenter, two stage, phase II study, evaluating the efficacy of oral BEZ235 plus best supportive care (BSC) versus placebo plus BSC in the treatment of patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy
R. Buzzoni 2013 II 6 Closed
Study Code
Title Coordinator Activated Closed Phase Total
patients
Patients enrolled in 2013 107/12
Randomized, couble-blind, phase 3 study of TAS- 102 plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic colorectal cancer refractory to standard chemotherapies
M. Di Bartolomeo
2013 III 9 Closed
accrual
117/12 Identification of circulating biomarkers of resistance to antiangiogenic treatment in patients with advanced colorectal cancer and assessment of their modification during therapy with antiangiogenic drugs (bevacizumab, aflibercept and regorafenib)
F. de Braud 2012 Observational 56 55
139/12 A phase II, multicenter, open-label, randomized study evaluating the efficacy and safety of Folfiri + MEHD7945A versus Folfiri + Cetuximab in second line in patients with KRAS Wild type metastatic colorectal cancer
M. Di Bartolomeo
2013 II 4 Closed
accrual
149/12 The EGF rs4444903 AG polymorphism in relationship to detection rate and tumour size at diagnosis in patients undergoing surveillance for HCC and to HCC doubling time
V. Mazzaferro
2013 01/07/13 Observational 58 58
03/13 Identification of Genetic Circulating Biomarkers for the Early Diagnosis of Colorectal Cancer
M. A. Pierotti 2013 Observational 115 115
07/13 A Phase III, Randomized, Double-Blind Study of Tivantinib (ARQ 197) in Subjects with MET Diagnostic-High Inoperable Hepatocellular Carcinoma (HCC) Treated with One Prior Systemic Therapy
V. Mazzaferro
2013 III 9 9
35/13 Prospective randomized phase II trial comparing mandatory second-look surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and cytoreductive surgery, vs. standard postoperative follow-up in patients at high risk of developing colorectal cancer peritoneal metastases
D. Baratti 2013 - 3 3
36/13 Identification of Genetic Circulating Biomarkers for monitoring and early detection of recurrence in surgically treated colorectal Cancer patients.
M. Gariboldi 2013 Observational 65 65
50/13 Perioperative treatment with COI-B (Capecitabine, Oxaliplatin, Irinotecan and Bevacizumab) of high risk or borderline resectable colorectal cancer liver metastases
F. De Braud 2013 II 7 7
79/13 A multicenter, stratified, open, randomized, comparator-controlled, parallelgroup phase III study comparing treatment with 177Lu-DOTA0- Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive midgut carcinoid tumours
E. Seregni 2013 III 1 1
87/13 Retrospective-prospective observational study on the natural history of brain metastases from colorectal cancer
F. De Braud 2013 Observational 39 39
110/13 IL-6-related inflammation signatures as a predictive marker of recurrence in liver cancer patients
V. Mazzaferro
Study Code
Title Coordinator Activated Closed Phase Total
patients
Patients enrolled in 2013 126/13 Prospective observational study on the impact
of genetic polymorphisms on the occurrence of chemotherapy-induced toxicity in gastrointestinal epithelial neoplasms
F. De Braud 2013 Observational 9 9
137/13 A Single-Arm, Open Label Study of Aflibercept as Maintenance Therapy Following Induction with Aflibercept in Combination with XELOX, as First- Line Treatment for Metastatic Colorectal Cancer Patient
M. Di Bartolomeo
2013 I-II 2 2
141/13 "A prospective, single-arm, multicenter,
uncontrolled, open-label Phase II trial of refametinib (BAY 86-9766) in patients with RAS mutant Hepatocellular Carcinoma
141/13 A prospective, single-arm, multicenter, uncontrolled, open-label Phase II trial of refametinib (BAY 86- 9766) in patients with RAS mutant Hepatocellular Carcinoma (HCC)
V. Mazzaferro
2013 II 8 8
159/13 DNA-seq analysis for prediction of outcome to first line irinotecan versus oxaliplatin-based regimens in advanced colorectal cancer patients enrolled in a randomized phase II, prospective study
M. Gariboldi 2013 Observational 43 43
61/09 An uncontrolled open label multicenter phase II safety study of BAY73-4506 in patients with hepatocellular carcinoma (HCC)
V. Mazzaferro
2010 09/07/13 II 2 Closed
accrual
64/10 The role of natural fluorescence of plasma in colorectal cancer patients
E. Leo 2010 30/04/13 - 200 Closed
accrual
14/12 Post-traumatic growth and psycho-social adaptation in patients submitted to liver transplant
C. Borreani 2012 12/11/13 Observational 233 10