Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-06 @ 5:37 PM
Study NCT ID:
NCT02076594
Status:
TERMINATED
Last Update Posted:
2019-10-09
First Post:
2013-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'whyStopped': 'The interim analysis performed on 09 November 2018, showed the failure to achieve the primary objective of effectiveness of the experimental treatment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-07', 'studyFirstSubmitDate': '2013-08-20', 'studyFirstSubmitQcDate': '2014-02-26', 'lastUpdatePostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Measured as the time from randomization to the date of local or regional progression, distant metastasis, second primary malignancy or death, assessed up to 18 months of follow up', 'description': 'To determine the progression free survival (PFS) of patients with locally advanced unresectable or metastatic gastric cancer treated with Docetaxel plus Oxaliplatin plus Capecitabine (Arm A) or with Epirubicin plus Oxaliplatin plus Capecitabine (Arm B)'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Measured as the time from randomization to the date of death from any cause, assessed up to 18 months of follow up', 'description': 'To assess overall survival (OS) of patients with locally advanced unresectable or metastatic gastric cancer treated with Docetaxel plus Oxaliplatin plus Capecitabine (Arm A) or with Epirubicin plus Oxaliplatin plus Capecitabine (Arm B)'}, {'measure': 'Objective Response Rate (CR + PR) according to RECIST 1.1 guideline', 'timeFrame': 'Measured as the time from randomization, assessed up to 18 months of follow up', 'description': 'To assess objective response rate (CR+PR)of patients with locally advanced unresectable or metastatic gastric cancer treated with Docetaxel plus Oxaliplatin plus Capecitabine (Arm A) or with Epirubicin plus Oxaliplatin plus Capecitabine (Arm B)'}, {'measure': 'Disease control rate: CR + PR + SD lasting > 12 weeks', 'timeFrame': 'Measured as the time from randomization, assessed up to 18 months of follow up', 'description': 'To assess disease control rate of patients with locally advanced unresectable or metastatic gastric cancer treated with Docetaxel plus Oxaliplatin plus Capecitabine (Arm A) or with Epirubicin plus Oxaliplatin plus Capecitabine (Arm B)'}, {'measure': 'Tolerability of the treatments evaluated in term of occurrence of: side effects graded according to the NCI-CTCAE scale (version 4.0); serious adverse reactions, expected and unexpected', 'timeFrame': 'Measured as the time from randomization, assessed up to 18 months of follow up', 'description': 'To assess tolerability of the treatments of patients with locally advanced unresectable or metastatic gastric cancer treated with Docetaxel plus Oxaliplatin plus Capecitabine (Arm A) or with Epirubicin plus Oxaliplatin plus Capecitabine (Arm B)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Locally Advanced Unresectable Gastric Cancer', 'Metastatic Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This is a randomized, parallel group, non-blinded phase III trial. Patients with advanced (locoregional or metastatic) gastric cancer not previously treated with chemotherapy for this stage will be randomized in a 1:1 ratio to receive low-TOX (arm A) or EOX (arm B). Randomization will be stratified by performance status (ECOG 0, 1 and 2).', 'detailedDescription': 'Although the incidence of the adenocarcinoma of the stomach is slowly decreasing, gastric cancer represents the second worldwide cause of cancer death after lung cancer. In patients with advanced disease, chemotherapy improves survival and quality of life. Combinations of two or three drugs including a platin derivative (cisplatin or oxaliplatin), a fluoropyrimidine (5FU or capecitabine) and an anthracycline (usually epirubicin) have demonstrated superiority compared to single or double agent therapy and are the current standard. As of today there are no published studies comparing anthracycline-based to taxane-based three-drug regimens. The objective of the present study is to compare EOX as evaluated in REAL-2 to the low-TOX regimen consisting of docetaxel, oxaliplatin and capecitabine. Low-TOX is expected to be better tolerated than the original DCF regimen. The study will be performed in the HER2 negative patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent prior to beginning protocol specific procedures\n* Male or female \\> 18 years of age\n* Histologically proven diagnosis of adenocarcinoma of the stomach\n* HER2 negative tumor or HER2+ tumors not qualifying for herceptin therapy\n* Locally advanced (non resectable) or metastatic gastric cancer\n* Presence of measurable disease with at least one measurable lesion by means of CT scan or MRI in not previously irradiated area(s) (according to RECIST criteria (version 1.1)\n* Life expectancy of \\>/= 3 months\n* ECOG performance status of 0-2 at study entry\n* Neutrophils \\>/= 2.0 x 1000000000/L, platelets \\>/= 100 x 1000000000/L, and hemoglobin \\>/= 10 g/dL\n* Bilirubin level either normal or \\</= 1.5 x ULN\n* AST and ALT \\</= 2.5 X UNL (\\</= 5 x ULN if liver metastasis are present\n* Alkaline phosphatase (ALP) \\</= 2.5 X ULN; patients with alkaline phosphatase \\> 2.5x ULN and AST and ALT \\</= 1.5 x ULN are equally eligible\n* Serum creatinine \\< 1.5 x ULN. In presence border-line values, the calculated creatinine clearance should be \\>/= 60 mL/min\n* Negative pregnancy test (if female in reproductive years)\n* Effective contraception prior to study entry and for the duration of the study participation, for both male and female patients of child producing potential\n* Able and willing to comply with scheduled visits, therapy plans and laboratory tests required in this protocol\n\nExclusion Criteria:\n\n* Previous chemotherapy, except adjuvant treatment administered at least 1 year before study entry\n* Concurrent chronic systemic immune therapy\n* Any investigational agent(s) 4 weeks prior to entry\n* Clinically relevant coronary artery disease or a history of a myocardial infarction or a history of hypertension not controlled by therapy within the last 12 months\n* Known hypersensitivity to study drugs. Known grade 3 or 4 allergic reaction to any of the components of the treatment\n* Known drug abuse/ alcohol abuse\n* Acute or subacute intestinal occlusion and any other significant chronic gastrointestinal disease that might interfere with absorption of oral treatment\n* History of clinically relevant psychiatric disability precluding informed consent\n* Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Pregnant or breastfeeding women\n* Active uncontrolled infection(s)\n* Positive for HIV serology and/or viral hepatitis B or C\n* Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial)'}, 'identificationModule': {'nctId': 'NCT02076594', 'briefTitle': 'Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente"}, 'officialTitle': 'A Randomized Phase III Study Of Low-Docetaxel Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin And Capecitabine (Eox) In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer', 'orgStudyIdInfo': {'id': 'LEGA'}, 'secondaryIdInfos': [{'id': '2011-005537-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Docetaxel & Oxaliplatin & Capecitabine', 'description': 'Patients will receive cycles every 3 weeks of Docetaxel (35 mg/ m2, intravenous at days 1 and 8 by 1-hour infusion)and Oxaliplatin (80 mg/ m2, intravenous at day 1 by 2-hour infusion) and Capecitabine (750 mg/ m2, oral tablets of 500 and 150 mg, x2 daily for 2 weeks)', 'interventionNames': ['Drug: Docetaxel', 'Drug: Oxaliplatin', 'Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Epirubicin & Oxaliplatin & Capecitabine', 'description': 'Patients will receive cycles every 3 weeks of Epirubicin (50 mg/ m2, intravenous on day 1 by 2-hour infusion)and Oxaliplatin (130 mg/ m2, intravenous on day 1 by 2-hour infusion) and Capecitabine (625 mg/ m2,oral tablets of 500 and 150 mg, x2 daily for 3 weeks)', 'interventionNames': ['Drug: Epirubicin', 'Drug: Oxaliplatin', 'Drug: Capecitabine']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere 20 mg/mL'], 'description': 'Powder for solution for infusion', 'armGroupLabels': ['Docetaxel & Oxaliplatin & Capecitabine']}, {'name': 'Epirubicin', 'type': 'DRUG', 'otherNames': ['Farmorubicina 2mg/mL'], 'description': 'Solution for infusion', 'armGroupLabels': ['Epirubicin & Oxaliplatin & Capecitabine']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['Eloxatin 5 mg/mL'], 'description': 'Powder for solution for infusion', 'armGroupLabels': ['Docetaxel & Oxaliplatin & Capecitabine', 'Epirubicin & Oxaliplatin & Capecitabine']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda 150 mg', 'Xeloda 500 mg'], 'description': 'Film coated tablets', 'armGroupLabels': ['Docetaxel & Oxaliplatin & Capecitabine', 'Epirubicin & Oxaliplatin & Capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'state': 'BA', 'country': 'Italy', 'facility': 'Istituto Tumori', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '24127', 'city': 'Bergamo', 'state': 'BG', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '24047', 'city': 'Treviglio', 'state': 'BG', 'country': 'Italy', 'facility': 'A.O. Treviglio-Caravaggio', 'geoPoint': {'lat': 45.52081, 'lon': 9.59102}}, {'zip': '09042', 'city': 'Monserrato', 'state': 'CA', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria di Cagliari', 'geoPoint': {'lat': 39.25642, 'lon': 9.1444}}, {'zip': '22020', 'city': 'Como', 'state': 'CO', 'country': 'Italy', 'facility': "Azienda Ospedaliera Sant'Anna", 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'zip': '23900', 'city': 'Lecco', 'state': 'LC', 'country': 'Italy', 'facility': 'Ospedale di Circolo A. Manzoni', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}, {'zip': '04100', 'city': 'Latina', 'state': 'LT', 'country': 'Italy', 'facility': 'Ospedale Santa Maria Goretti Latina', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}, {'zip': '55041', 'city': 'Camaiore', 'state': 'LU', 'country': 'Italy', 'facility': 'A.O. Ospedale Versilia', 'geoPoint': {'lat': 43.94265, 'lon': 10.29754}}, {'zip': '98039', 'city': 'Taormina', 'state': 'ME', 'country': 'Italy', 'facility': 'P.O. "San Vincenzo" Taormina', 'geoPoint': {'lat': 37.85358, 'lon': 15.28851}}, {'zip': '20064', 'city': 'Gorgonzola', 'state': 'MI', 'country': 'Italy', 'facility': 'Osped. Di Circolo Serbelloni-Gorgonzola', 'geoPoint': {'lat': 45.53069, 'lon': 9.40531}}, {'zip': '20133', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20141', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'IRCCS Istituto Europeo di Oncologia (IEO)', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20142', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Azienda Ospedaliera San Paolo', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20157', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Ospedale L. Sacco', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '41012', 'city': 'Carpi', 'state': 'MO', 'country': 'Italy', 'facility': 'Ospedale di Carpi', 'geoPoint': {'lat': 44.78237, 'lon': 10.8777}}, {'zip': '29100', 'city': 'Piacenza', 'state': 'PC', 'country': 'Italy', 'facility': 'AUSL di Piacenza', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'zip': '61122', 'city': 'Pesaro', 'state': 'PE', 'country': 'Italy', 'facility': 'A.O. Ospedali Riuniti Marche Nord - Presidio S. Salvatore Muraglia', 'geoPoint': {'lat': 43.90921, 'lon': 12.9164}}, {'zip': '65124', 'city': 'Pescara', 'state': 'PE', 'country': 'Italy', 'facility': 'A. O. di Pescara - Ospedale Civile Spirito Santo', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'zip': '59100', 'city': 'Prato', 'state': 'PO', 'country': 'Italy', 'facility': 'Ospedale Misericordia e Dolce', 'geoPoint': {'lat': 43.8805, 'lon': 11.09699}}, {'zip': '85100', 'city': 'Potenza', 'state': 'PZ', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Ospedale San Carlo', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}, {'zip': '42100', 'city': 'Reggio Emilia', 'state': 'RE', 'country': 'Italy', 'facility': 'Ospedale di S. Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '00186', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Ospedale Fatebenefratelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '21100', 'city': 'Varese', 'state': 'VA', 'country': 'Italy', 'facility': 'Ospedale di Circolo e Fondazione Macchi di Varese', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '37024', 'city': 'Negrar', 'state': 'VR', 'country': 'Italy', 'facility': 'Ospedale Sacro Cuore Don Calabria di Negrar', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'IRCCS Istituto Nazionale Tumori Fondazione Pascale', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'overallOfficials': [{'name': 'Roberto Labianca, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'A.O. Papa Giovanni XXIII di Bergamo, Oncologia Medica'}, {'name': 'Enrico Cortesi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico Umbero I di Roma, UOC Oncologia Medica B'}, {'name': 'Domenico Cristiano Corsi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Fatebenefratelli di Roma, Oncologia'}, {'name': 'Pietro Sozzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale degli Infermi di Biella, Oncologia'}, {'name': 'Luigi Cavanna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AUSL di Piacenza, Oncologia Medica'}, {'name': 'Domenico Bilancia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. Ospedale San Carlo di Potenza, Oncologia Medica'}, {'name': 'Rosa Rita Silva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASUR Zona 6 di Fabriano, Oncologia'}, {'name': 'Nicola Fazio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Istituto Europeo di Oncologia di Milano, Tumori digestivi superiori e Neuroendocrini'}, {'name': 'Monica Giordano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "A. O. Sant'Anna di Como, Oncologia"}, {'name': 'Alessandro Bertolini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Civile di Sondrio, Oncologia Medica'}, {'name': 'Giovanni Ucci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. Ospedale Maggiore di Lodi, Oncologia'}, {'name': 'Donato Natale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. di Pescara - Oncologia'}, {'name': 'Daris Ferrari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. San Paolo di Milano, Oncologia Medica'}, {'name': 'Graziella Pinotti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale di Circolo e Fondazione Macchi di Varese, Oncologia'}, {'name': 'Ermanno Rondini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale di S. Maria Nuova di Reggio Emilia, Oncologia Medica'}, {'name': 'Massimo Cirillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Sacro Cuore Don Calabria di Negrar, Oncologia Medica'}, {'name': 'Rosario Vincenzo Iaffaioli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Istituto Nazionale Tumori Fondazione Pascale di Napoli, Oncologia Medica Addominale'}, {'name': 'Andrea Ciarlo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Misericordia e Dolce di Prato, Oncologia Medica'}, {'name': 'Elena Piazza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale L. Sacco di Milano, Oncologia'}, {'name': 'Libero Ciuffreda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera Città della Salute e della Scienza di Torino, Oncologia Medica'}, {'name': "Stefania Dell'Oro, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale di Circolo A. Manzoni di Lecco, Oncologia Medica'}, {'name': 'Fabrizio Artioli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale di Carpi, Medicina Oncologica'}, {'name': 'Claudio Verusio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Generale Provinciale di Saronno, Oncologia Medica'}, {'name': 'Vincenzo Catalano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. Ospedali Riuniti Marche Nord - Presidio S. Salvatore Muraglia, Oncologia'}, {'name': 'Claudio Graiff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASDAA Bolzano, Oncologia Medica'}, {'name': 'Domenico Amoroso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. Ospedale Versilia di Camaiore, Oncologia Medica'}, {'name': 'Maria Di Bartolomeo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Medicina Oncologica 1'}, {'name': 'Nicola Silvestris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Tumori di Bari, Oncologia Medica'}, {'name': 'Maria C. Zavettieri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSPED. DI CIRCOLO SERBELLONI-GORGONZOLA - GORGONZOLA (MI)'}, {'name': 'Enzo Veltri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSPEDALE SANTA MARIA GORETTI LATINA'}, {'name': 'Francesco Ferraù, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'P.O. "SAN VINCENZO" TAORMINA - TAORMINA (ME)'}, {'name': 'Giampaolo Tortora, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSPEDALE POLICLINICO G.B. ROSSI (BORGO ROMA) DI VERONA'}, {'name': 'Sandro Barni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. TREVIGLIO-CARAVAGGIO - TREVIGLIO (BG)'}, {'name': 'Mario Scartozzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O.U. di Cagliari - Presidio di Monserrato'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente", 'class': 'OTHER'}, 'collaborators': [{'name': 'Regione Lombardia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}