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Tarceva Italian Lung Optimization tRial (TAILOR)

Primary Purpose

Non Small Cell Lung Cancer (NSCLC)

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Erlotinib
Docetaxel
Sponsored by
Fatebenefratelli and Ophthalmic Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer (NSCLC) focused on measuring Advanced NSCLC, EGFR, EGFR copy number, Kras mutations, EGRF mutations, Docetaxel, Erlotinib, Polymorphisms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or older
  • Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples may be included in the study
  • Absence of EGFR mutations of exons 19 or 21 (randomization)
  • Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
  • One prior platinum-based at adequate doses and taxane free regimen
  • Measurable (uni-dimensional) disease by RECIST in a lesion not previously irradiated or non-measurable disease
  • ECOG-PS 0-2
  • ANC greater than 1.5 x 109/L and platelets greater than 100 x 109/L
  • Bilirubin level either normal or <1.5xULN
  • AST (SGOT) and ALT (SGPT) <2.5xULN (≤5 x ULN if liver metastases are present)
  • Serum creatinine <1.5xULN
  • Effective contraception for both, male and female pts, if the risk of conception exists
  • Recovery from all acute toxicities of prior therapies
  • Provision of written informed consent to the analysis of biological markers (registration)
  • Provision of written informed consent to enter the randomized part of the study (randomization)

Exclusion Criteria:

  • Prior therapy with an experimental agent whose primary mechanism of action is inhibition of EGFR or its associated tyrosine kinase
  • Prior chemotherapy with taxanes
  • Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 daysLess than 14 days since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
  • Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion of the investigator, makes it inappropriate for the patient to be enrolled in the study Known severe hypersensitivity to erlotinib or any of the excipients of this product
  • Known hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated with polysorbate 80, or any of the excipients of docetaxel
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Unable to swallow tablets
  • Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangitic carcinomatosis need not be excluded)
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  • As judged by the investigator, any inflammatory changes of the surface of the eye
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Sites / Locations

  • Ospedale Civili Riuniti Giovanni Paolo II
  • Fabriano Hospital
  • Ospedali Riuniti Umberto I - Lancisi - Salesi
  • Oncologia A.S.L. AV1
  • Pesenti-Fenaroli HospitalRecruiting
  • Ospedale di Vipiteno
  • Oncologia Medica Azienda Spedali CiviliRecruiting
  • Pneumologia Azienda Spedali CiviliRecruiting
  • Ospedale centrale di BolzanoRecruiting
  • Policlinico Universitario di MonserratoRecruiting
  • Ospedale Santa Barbara
  • Renzetti HospitalRecruiting
  • Ospedale S. Elia
  • San Francesco Hospital
  • Ospedale Civile di Saluzzo Savigliano
  • Istituto Toscano Tumori Ospedale S. Giuseppe Antica SedeRecruiting
  • Monfalcone Hospital
  • Ospedale Civile Ferrari
  • Ospedale Civile di Casalpusterlengo
  • Ospedale S. Maria Goretti
  • B. Eustachio Hospital
  • San Vincenzo HospitalRecruiting
  • Azienda Ospedaliera Melegnano- P.O. GorgonzolaRecruiting
  • Legnano HospitalRecruiting
  • Ospedale Civile di Legnano -Presidio di Magenta
  • San Gerardo Hospital
  • Rho Hospital - Azienda Ospedaliera Salvini-Garbagnate
  • Policlinico San Donato
  • IRCCS MultimedicaRecruiting
  • Ospedale Civile di VimercateRecruiting
  • Vizzolo Predabissi Hospital
  • San Leonardo Hospital
  • Ospedale Civile Vigevano
  • Policlinico Universitario PalermoRecruiting
  • San Massimo Hospital
  • Centro di Riferimento Oncologico
  • Umberto I HospitalRecruiting
  • Ospedale Civile di Siderno - ASL n°9 Locri
  • S. Sebastiano HospitalRecruiting
  • Ospedale di Scandiano
  • S. Giovanni Evangelista HospitalRecruiting
  • ASL SA1 -P.O. Umberto IRecruiting
  • Presidio Ospedaliero San Luca
  • Ospedale Valdichiana "Nottola"Recruiting
  • Ospedale Valdelsa "Campostaggia"Recruiting
  • Ospedale di TerniRecruiting
  • Multimedia Santa MariaRecruiting
  • Azienda Ospedaliera Busto ArsizioRecruiting
  • Umberto I Hospital
  • Ospedale Mater SalutisRecruiting
  • Ospedale Policlinico G.B. Rossi
  • S. Giovanni di Dio Hospital
  • Ospedale San Donato
  • Azienda Ospedaliera Universitaria Consorziale Policlinico
  • Fatebenefratelli Hospital
  • G. Rummo HospitalRecruiting
  • Ospedali RiunitiRecruiting
  • Armando Businco Oncological HospitalRecruiting
  • Presidio Ospedaliero Cardarelli ASL 3
  • Sant'Anna Hospital
  • Mariano Santo Hospital
  • Ospedale Maggiore di Crema
  • S. Croce e Carle HospitalRecruiting
  • A.O.U. S. Anna
  • A.O.U. Careggi
  • Azienda Ospedaliero Universitaria Careggi
  • A.O. San Martino
  • Galliera HospitalRecruiting
  • F. Veneziale HospitalRecruiting
  • Azienda Ospedaliera di LeccoRecruiting
  • Fatebenefratelli and Ophthalmic HospitalRecruiting
  • Fondazione Ospedale Maggiore Policlinico - Mangiagalli e Regina ElenaRecruiting
  • San Paolo HospitalRecruiting
  • San Carlo Borromeo HospitalRecruiting
  • Azienda Ospedaliera Luigi Sacco Polo UniversitarioRecruiting
  • A.O. Monaldi
  • Cardarelli Hospital
  • D. Cotugno Hospital
  • San Gennaro Hospital - ASL NA 1
  • Ospedale Maggiore della CaritàRecruiting
  • Azienda Ospedaliera Universitaria Presidio "Paolo Giaccone"
  • Presidio Ospedaliero "M. Ascoli" ARNAS Civico
  • Centro Oncologico "La Maddalena"
  • S. Maria della Misericordia Hospital
  • Piacenza HospitalRecruiting
  • S. Maria degli Angeli HospitalRecruiting
  • Ospedale Civile Santa Maria delle CrociRecruiting
  • Arcispedale S. Maria Nuova
  • Ospedale San Pietro FatebenefratelliRecruiting
  • Pneumologia Oncologica II-San Camillo Forlanini Hospital
  • Oncologia Medica-San Camillo Forlanini HopsitalRecruiting
  • Università Campus Bio-Medico
  • Policlinico Umberto IRecruiting
  • Policlinico Umberto IRecruiting
  • S. Giovanni - Addolorata HospitalRecruiting
  • Azienda Ospedaliera S. Giovanni di Dio e Ruggi d'Aragona
  • Ospedale Civile SS. AnnunziataRecruiting
  • Universita' di Sassari Oncologia MedicaRecruiting
  • Ospedale MorelliRecruiting
  • Sondrio Hospital-Azienda Ospedaliera Valtellina e ValchiavennaRecruiting
  • A.O.U. San Giovanni Battista MolinetteRecruiting
  • Ospedale di Circolo
  • SS. Giovanni e Paolo Hospital
  • San Bartolo Hospital
  • Belcolle HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Erlotinib Arm

Docetaxel Arm

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progression Free Survival
Response assessed with RECIST criteria
Quality of Life assessed with QLQ-C30 and QLQ-LC13 questionnaires
Toxicity, graded according to the NCI-CTAE version 3.0
Frequency and nature of serious adverse reactions
Premature withdrawals

Full Information

First Posted
March 12, 2008
Last Updated
February 23, 2012
Sponsor
Fatebenefratelli and Ophthalmic Hospital
Collaborators
Mario Negri Institute for Pharmacological Research, Niguarda Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00637910
Brief Title
Tarceva Italian Lung Optimization tRial
Acronym
TAILOR
Official Title
Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatebenefratelli and Ophthalmic Hospital
Collaborators
Mario Negri Institute for Pharmacological Research, Niguarda Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to assess the superiority of docetaxel in comparison to erlotinib in second line in wild-type EGFR tumour patients.
Detailed Description
Erlotinib is registered in all patients affected with NSCLC in second and subsequent lines with a small benefit on Overall Survival. Recent evidence suggest that patients with EGFR mutations have a clear benefit when they are treated with EGFR tyrosine kinase inhibitors, while the role of these drugs in wild-type EGFR patients, that are representing the large majority (about 85-90%), is still unclear and no properly planned trials assessed before this issue. Recently, indirect evidence on subgroup analyses on randomized trial suggest that chemotherapy might be superior to erlotinib in wild-type EGFR patients. Moreover, several authors do not recommend the use of EGFR determined with immunohistochemistry (IHC) or FISH because they do not reproducibly predict outcome. For these reasons the protocol was amended in May 2011 in a superiority trial of docetaxel versus erlotinib, while the first version was aimed to assess the interaction with biomarkers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer (NSCLC)
Keywords
Advanced NSCLC, EGFR, EGFR copy number, Kras mutations, EGRF mutations, Docetaxel, Erlotinib, Polymorphisms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erlotinib Arm
Arm Type
Experimental
Arm Title
Docetaxel Arm
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel 75 mg/mq on day 1, every 21 days (3-weekly schedule) or Docetaxel 35 mg/mq 0n day 1,8 and 15 every 28 days (weekly schedule). _Until disease progression or unacceptable toxicity develops
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
12 months after the last patient is randomized
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
with 4 years and 12 months after the last patient is randomized
Title
Response assessed with RECIST criteria
Time Frame
within 4 years
Title
Quality of Life assessed with QLQ-C30 and QLQ-LC13 questionnaires
Time Frame
within 4 years
Title
Toxicity, graded according to the NCI-CTAE version 3.0
Time Frame
within 4 years
Title
Frequency and nature of serious adverse reactions
Time Frame
within 4 years
Title
Premature withdrawals
Time Frame
within 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples may be included in the study Absence of EGFR mutations of exons 19 or 21 (randomization) Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy One prior platinum-based at adequate doses and taxane free regimen Measurable (uni-dimensional) disease by RECIST in a lesion not previously irradiated or non-measurable disease ECOG-PS 0-2 ANC greater than 1.5 x 109/L and platelets greater than 100 x 109/L Bilirubin level either normal or <1.5xULN AST (SGOT) and ALT (SGPT) <2.5xULN (≤5 x ULN if liver metastases are present) Serum creatinine <1.5xULN Effective contraception for both, male and female pts, if the risk of conception exists Recovery from all acute toxicities of prior therapies Provision of written informed consent to the analysis of biological markers (registration) Provision of written informed consent to enter the randomized part of the study (randomization) Exclusion Criteria: Prior therapy with an experimental agent whose primary mechanism of action is inhibition of EGFR or its associated tyrosine kinase Prior chemotherapy with taxanes Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 daysLess than 14 days since completion of prior radiotherapy or persistence of any radiotherapy related toxicity Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion of the investigator, makes it inappropriate for the patient to be enrolled in the study Known severe hypersensitivity to erlotinib or any of the excipients of this product Known hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated with polysorbate 80, or any of the excipients of docetaxel Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ Unable to swallow tablets Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangitic carcinomatosis need not be excluded) As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease) As judged by the investigator, any inflammatory changes of the surface of the eye Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina C Garassino, MD
Phone
+39 0263632223
Email
marina.garassino@fbf.milano.it
First Name & Middle Initial & Last Name or Official Title & Degree
Serena Girelli, Biologist
Phone
+39 0263632223
Email
datamanager@fbf.milano.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Scanni, MD
Organizational Affiliation
Fatebenefratelli and Ophthalmic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Civili Riuniti Giovanni Paolo II
City
Sciacca
State/Province
Agrigento
ZIP/Postal Code
92100
Country
Italy
Individual Site Status
Terminated
Facility Name
Fabriano Hospital
City
Fabriano
State/Province
Ancona
ZIP/Postal Code
60044
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Ospedali Riuniti Umberto I - Lancisi - Salesi
City
Torrette
State/Province
Ancona
ZIP/Postal Code
60020
Country
Italy
Individual Site Status
Terminated
Facility Name
Oncologia A.S.L. AV1
City
Ariano Irpino
State/Province
Avellino
ZIP/Postal Code
83031
Country
Italy
Individual Site Status
Terminated
Facility Name
Pesenti-Fenaroli Hospital
City
Alzano Lombardo
State/Province
Bergamo
ZIP/Postal Code
24022
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Nastasi, MD
Phone
+39 0354177235
Email
giuseppe.nastasi@bolognini.bg.it
First Name & Middle Initial & Last Name & Degree
Giuseppe Nastasi, MD
Facility Name
Ospedale di Vipiteno
City
Vipiteno
State/Province
Bolzano
ZIP/Postal Code
39049
Country
Italy
Individual Site Status
Terminated
Facility Name
Oncologia Medica Azienda Spedali Civili
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vittorio Ferrari, MD
Phone
+39 0303996583
Email
bscivile@numerica.it
First Name & Middle Initial & Last Name & Degree
Vittorio Ferrari, MD
Facility Name
Pneumologia Azienda Spedali Civili
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vittorio Ferrari, MD
Phone
+39 0303996583
Email
bscivile@numerica.it
First Name & Middle Initial & Last Name & Degree
Vittorio Ferrari, MD
Facility Name
Ospedale centrale di Bolzano
City
Bolzano
State/Province
BZ
ZIP/Postal Code
39100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuela Vattemi, MD
Phone
+39 0471908952
Email
emanuela.vattemi@asbz.it
First Name & Middle Initial & Last Name & Degree
Emanuela Vattemi, MD
Facility Name
Policlinico Universitario di Monserrato
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09042
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Massidda, MD
Phone
+39 07051096208
Email
masbru@pacs.unica.it
First Name & Middle Initial & Last Name & Degree
Bruno Massidda, MD
Facility Name
Ospedale Santa Barbara
City
Iglesias
State/Province
Carbonia Iglesias
ZIP/Postal Code
09016
Country
Italy
Individual Site Status
Terminated
Facility Name
Renzetti Hospital
City
Lanciano
State/Province
Chieti
ZIP/Postal Code
66034
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Nuzzo, MD
Phone
+39 0872706220
Email
nuzzo@oncologialanciano.it
First Name & Middle Initial & Last Name & Degree
Antonio Nuzzo, MD
Facility Name
Ospedale S. Elia
City
Caltanissetta
State/Province
CL
ZIP/Postal Code
93100
Country
Italy
Individual Site Status
Terminated
Facility Name
San Francesco Hospital
City
Paola
State/Province
Cosenza
ZIP/Postal Code
87027
Country
Italy
Individual Site Status
Terminated
Facility Name
Ospedale Civile di Saluzzo Savigliano
City
Saluzzo
State/Province
Cuneo
ZIP/Postal Code
12037
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Istituto Toscano Tumori Ospedale S. Giuseppe Antica Sede
City
Empoli
State/Province
Firenze
ZIP/Postal Code
50053
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianmaria Fiorentini, MD
Phone
+39 0571702284
Email
oncologiaempoli@usl11.toscana.it
First Name & Middle Initial & Last Name & Degree
Gianmaria Fiorentini, MD
Facility Name
Monfalcone Hospital
City
Monfalcone
State/Province
Gorizia
ZIP/Postal Code
34074
Country
Italy
Individual Site Status
Terminated
Facility Name
Ospedale Civile Ferrari
City
Casarano
State/Province
Lecce
ZIP/Postal Code
73042
Country
Italy
Individual Site Status
Terminated
Facility Name
Ospedale Civile di Casalpusterlengo
City
Casalpusterlengo
State/Province
Lodi
ZIP/Postal Code
26841
Country
Italy
Individual Site Status
Terminated
Facility Name
Ospedale S. Maria Goretti
City
Latina
State/Province
LT
ZIP/Postal Code
04100
Country
Italy
Individual Site Status
Terminated
Facility Name
B. Eustachio Hospital
City
San Severino Marche
State/Province
Macerata
ZIP/Postal Code
62027
Country
Italy
Individual Site Status
Terminated
Facility Name
San Vincenzo Hospital
City
Taormina
State/Province
Messina
ZIP/Postal Code
98039
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Ferrau, MD
Phone
+39 0942579322331
Email
omtaormina@tin.it
First Name & Middle Initial & Last Name & Degree
Francesco Ferrau, MD
Facility Name
Azienda Ospedaliera Melegnano- P.O. Gorgonzola
City
Gorgonzola
State/Province
Milano
ZIP/Postal Code
20069
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciano Isa, MD
Phone
+39 0295707207
Email
luciano.isa@tiscalinet.it
First Name & Middle Initial & Last Name & Degree
Luciano Isa, MD
Facility Name
Legnano Hospital
City
Legnano
State/Province
Milano
ZIP/Postal Code
20025
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giambattista Roda, MD
Phone
+39 0331449306
Email
laelena75@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gianbattista Roda, MD
Facility Name
Ospedale Civile di Legnano -Presidio di Magenta
City
Magenta
State/Province
Milano
ZIP/Postal Code
20013
Country
Italy
Individual Site Status
Withdrawn
Facility Name
San Gerardo Hospital
City
Monza
State/Province
Milano
ZIP/Postal Code
20052
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Rho Hospital - Azienda Ospedaliera Salvini-Garbagnate
City
Rho
State/Province
Milano
ZIP/Postal Code
20017
Country
Italy
Individual Site Status
Terminated
Facility Name
Policlinico San Donato
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Individual Site Status
Terminated
Facility Name
IRCCS Multimedica
City
Sesto San Giovanni
State/Province
Milano
ZIP/Postal Code
20099
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ornella Gottardi, MD
Phone
+39 02 24209498
Email
ornella.gottardi@multimedica.it
First Name & Middle Initial & Last Name & Degree
Ornella Gottardi, MD
Facility Name
Ospedale Civile di Vimercate
City
Vimercate
State/Province
Milano
ZIP/Postal Code
20059
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Fagnani, MD
Phone
+39 0362383230
Email
daniele.fagnani@libero.it
First Name & Middle Initial & Last Name & Degree
Daniele Fagnani, MD
Facility Name
Vizzolo Predabissi Hospital
City
Vizzolo Predabissi
State/Province
Milano
ZIP/Postal Code
20070
Country
Italy
Individual Site Status
Terminated
Facility Name
San Leonardo Hospital
City
Gragnano
State/Province
Napoli
ZIP/Postal Code
80054
Country
Italy
Individual Site Status
Terminated
Facility Name
Ospedale Civile Vigevano
City
Vigevano
State/Province
Pavia
ZIP/Postal Code
27029
Country
Italy
Individual Site Status
Terminated
Facility Name
Policlinico Universitario Palermo
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Palmeri, MD
Phone
+39 0916552506
Email
sergiopalmeri@alice.it
First Name & Middle Initial & Last Name & Degree
Sergio Palmeri, MD
Facility Name
San Massimo Hospital
City
Penne
State/Province
Pescara
ZIP/Postal Code
65017
Country
Italy
Individual Site Status
Terminated
Facility Name
Centro di Riferimento Oncologico
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Umberto I Hospital
City
Lugo
State/Province
Ravenna
ZIP/Postal Code
48022
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgio Cruciani, MD
Phone
+39 0545214081
Email
g.cruciani@ausl.ra.it
First Name & Middle Initial & Last Name & Degree
Giorgio Cruciani, MD
Facility Name
Ospedale Civile di Siderno - ASL n°9 Locri
City
Siderno
State/Province
Reggio Calabria
ZIP/Postal Code
89946
Country
Italy
Individual Site Status
Terminated
Facility Name
S. Sebastiano Hospital
City
Correggio
State/Province
Reggio Emilia
ZIP/Postal Code
42015
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Zoboli, MD
Phone
+39 0522 630111
Email
zobolia@ausl.re.it
First Name & Middle Initial & Last Name & Degree
Alessandra Zoboli, MD
Facility Name
Ospedale di Scandiano
City
Scandiano
State/Province
Reggio Emilia
ZIP/Postal Code
42019
Country
Italy
Individual Site Status
Terminated
Facility Name
S. Giovanni Evangelista Hospital
City
Tivoli
State/Province
Roma
ZIP/Postal Code
00019
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Spremberg, MD
Phone
+39 07743164353
Email
franco.spremberg@libero.it
First Name & Middle Initial & Last Name & Degree
Franco Spremberg, MD
Facility Name
ASL SA1 -P.O. Umberto I
City
Nocera Inferiore
State/Province
Salerno
ZIP/Postal Code
84014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Grimaldi, MD
Phone
+39 0819213331
Email
gsgrimaldi@fastwebnet.it
First Name & Middle Initial & Last Name & Degree
Giuseppe Grimaldi, MD
Facility Name
Presidio Ospedaliero San Luca
City
Vallo della Lucania
State/Province
Salerno
ZIP/Postal Code
84078
Country
Italy
Individual Site Status
Terminated
Facility Name
Ospedale Valdichiana "Nottola"
City
Montepulciano
State/Province
Siena
ZIP/Postal Code
53045
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Crispino, MD
Phone
+39 0578713111
Email
dip.oncologico@usl7.toscana.it
First Name & Middle Initial & Last Name & Degree
Sergio Crispino, MD
Facility Name
Ospedale Valdelsa "Campostaggia"
City
Poggibonsi
State/Province
Siena
ZIP/Postal Code
53036
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Crispino, MD
Phone
+39 0577586927
Email
s.crispino@usl7.toscana.it
First Name & Middle Initial & Last Name & Degree
Sergio Crispino, MD
Facility Name
Ospedale di Terni
City
Terni
State/Province
TR
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fausto Roila, MD
Phone
+39 0744205584
Email
roila.fausto@libero.it
First Name & Middle Initial & Last Name & Degree
Fausto Roila, MD
Facility Name
Multimedia Santa Maria
City
Castellanza
State/Province
Varese
ZIP/Postal Code
21053
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ornella Gottardi, MD
Phone
+39 0331476111
Email
ornella.gottardi@multimedica.it
First Name & Middle Initial & Last Name & Degree
Ornella Gottardi, MD
Facility Name
Azienda Ospedaliera Busto Arsizio
City
Saronno
State/Province
Varese
ZIP/Postal Code
21047
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Verusio, MD
Phone
+39 029613576
Email
cverusio@aobusto.it
First Name & Middle Initial & Last Name & Degree
Claudio Verusio, MD
Facility Name
Umberto I Hospital
City
Mestre
State/Province
Venezia
ZIP/Postal Code
30174
Country
Italy
Individual Site Status
Terminated
Facility Name
Ospedale Mater Salutis
City
Legnago
State/Province
Verona
ZIP/Postal Code
37045
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Bonetti, MD
Phone
0039.0442632418
Email
andrea.bonetti@aulsslegnago.it
First Name & Middle Initial & Last Name & Degree
Andrea Bonetti, MD
Facility Name
Ospedale Policlinico G.B. Rossi
City
Verona
State/Province
VR
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Terminated
Facility Name
S. Giovanni di Dio Hospital
City
Agrigento
ZIP/Postal Code
92100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Ospedale San Donato
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Individual Site Status
Terminated
Facility Name
Azienda Ospedaliera Universitaria Consorziale Policlinico
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Fatebenefratelli Hospital
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Individual Site Status
Terminated
Facility Name
G. Rummo Hospital
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Daniele, MD
Phone
+39 082457724
Email
bruno.daniele@ao-rummo.it
First Name & Middle Initial & Last Name & Degree
Bruno Daniele, MD
Facility Name
Ospedali Riuniti
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Labianca, MD
Phone
+39 035 269724859
Email
rlabian@tin.it
First Name & Middle Initial & Last Name & Degree
Roberto Labianca, MD
Facility Name
Armando Businco Oncological Hospital
City
Cagliari
ZIP/Postal Code
09100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efisio Defraia, MD
Phone
+39 0706095332
Email
defraiae@alice.it
First Name & Middle Initial & Last Name & Degree
Efisio Defraia, MD
Facility Name
Presidio Ospedaliero Cardarelli ASL 3
City
Campobasso
ZIP/Postal Code
86100
Country
Italy
Individual Site Status
Terminated
Facility Name
Sant'Anna Hospital
City
Como
ZIP/Postal Code
22100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Mariano Santo Hospital
City
Cosenza
ZIP/Postal Code
87100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Ospedale Maggiore di Crema
City
Crema
ZIP/Postal Code
26013
Country
Italy
Individual Site Status
Terminated
Facility Name
S. Croce e Carle Hospital
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida Colantonio, MD
Phone
+39 0171616739
Email
i.colantonio@libero.it
First Name & Middle Initial & Last Name & Degree
Ida Colantonio, MD
Facility Name
A.O.U. S. Anna
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Individual Site Status
Terminated
Facility Name
A.O.U. Careggi
City
Firenze
ZIP/Postal Code
50130
Country
Italy
Individual Site Status
Terminated
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Firenze
ZIP/Postal Code
50130
Country
Italy
Individual Site Status
Terminated
Facility Name
A.O. San Martino
City
Genova
ZIP/Postal Code
16100
Country
Italy
Individual Site Status
Terminated
Facility Name
Galliera Hospital
City
Genova
ZIP/Postal Code
16128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Decensi, MD
Phone
+39 010 5634501
Email
andrea.decensi@galliera.it
First Name & Middle Initial & Last Name & Degree
Andrea Decensi, MD
Facility Name
F. Veneziale Hospital
City
Isernia
ZIP/Postal Code
86170
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liberato Di Lullo, MD
Phone
+39 0865442212
Email
oncologia.is@infinito.it
First Name & Middle Initial & Last Name & Degree
Liberato Di Lullo, MD
Facility Name
Azienda Ospedaliera di Lecco
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Ardizzoia, MD
Phone
+39 0341489900
Email
antonio.ardizoia@tin.it
First Name & Middle Initial & Last Name & Degree
Antonio Ardizzoia, MD
Facility Name
Fatebenefratelli and Ophthalmic Hospital
City
Milano
ZIP/Postal Code
20121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriella Farina, MD
Phone
+39 0263632223
Email
gabriella.farina@fbf.milano.it
First Name & Middle Initial & Last Name & Degree
Marina C Garassino, MD
Phone
+39 0263632223
Email
marina.garassino@fbf.milano.it
First Name & Middle Initial & Last Name & Degree
Gabriella Farina, MD
Facility Name
Fondazione Ospedale Maggiore Policlinico - Mangiagalli e Regina Elena
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Tomirotti, MD
Phone
+39 0255034670
Email
mtomirotti@policlinico.mi.it
First Name & Middle Initial & Last Name & Degree
Maurizio Tomirotti, MD
Facility Name
San Paolo Hospital
City
Milano
ZIP/Postal Code
20142
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Foa, MD
Phone
+39 0250323085
Email
paolo.foa@unimi.it
First Name & Middle Initial & Last Name & Degree
Paolo Foa, MD
Facility Name
San Carlo Borromeo Hospital
City
Milano
ZIP/Postal Code
20153
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Cristina Locatelli, MD
Phone
+39 0240222270
Email
locatellimc@hotmail.com;
First Name & Middle Initial & Last Name & Degree
Maria Cristina Locatelli Locatelli, MD
Facility Name
Azienda Ospedaliera Luigi Sacco Polo Universitario
City
Milano
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Piazza, MD
Phone
+39 0239042493
Email
e.piazza@hsacco.it
First Name & Middle Initial & Last Name & Degree
Elena Piazza, MD
Facility Name
A.O. Monaldi
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Terminated
Facility Name
Cardarelli Hospital
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Terminated
Facility Name
D. Cotugno Hospital
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Terminated
Facility Name
San Gennaro Hospital - ASL NA 1
City
Napoli
ZIP/Postal Code
80136
Country
Italy
Individual Site Status
Terminated
Facility Name
Ospedale Maggiore della Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Alabiso, MD
Phone
+39 03213733984
Email
alabiso@med.unipmn.it
First Name & Middle Initial & Last Name & Degree
Oscar Alabiso, MD
Facility Name
Azienda Ospedaliera Universitaria Presidio "Paolo Giaccone"
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Terminated
Facility Name
Presidio Ospedaliero "M. Ascoli" ARNAS Civico
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Terminated
Facility Name
Centro Oncologico "La Maddalena"
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Individual Site Status
Terminated
Facility Name
S. Maria della Misericordia Hospital
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Individual Site Status
Terminated
Facility Name
Piacenza Hospital
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Cavanna, MD
Phone
+39 0523302697
Email
l.cavanna@ausl.pc.it
First Name & Middle Initial & Last Name & Degree
Luigi Cavanna, MD
Facility Name
S. Maria degli Angeli Hospital
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Tumolo, MD
Phone
+39 0434399464
Email
salvatore.tumolo@aopn.fvg.it
First Name & Middle Initial & Last Name & Degree
Salvatore Tumolo, MD
Facility Name
Ospedale Civile Santa Maria delle Croci
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgio Cruciani, MD
Phone
0039.054428530
Email
g.cruciani@ausl.ra.it
First Name & Middle Initial & Last Name & Degree
Giorgio Cruciani, MD
Facility Name
Arcispedale S. Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Ospedale San Pietro Fatebenefratelli
City
Roma
ZIP/Postal Code
00100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida Pavese, MD
Phone
0039.0633582831
Email
idapavese@yahoo.it
First Name & Middle Initial & Last Name & Degree
Ida Pavese, MD
Facility Name
Pneumologia Oncologica II-San Camillo Forlanini Hospital
City
Roma
ZIP/Postal Code
00149
Country
Italy
Individual Site Status
Terminated
Facility Name
Oncologia Medica-San Camillo Forlanini Hopsital
City
Roma
ZIP/Postal Code
00152
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cora N Sternberg, MD
Phone
+39 0658704317
Email
csternberg@scamilloforlanini.rm.it
First Name & Middle Initial & Last Name & Degree
Cora N Sternberg, MD
Facility Name
Università Campus Bio-Medico
City
Roma
ZIP/Postal Code
00155
Country
Italy
Individual Site Status
Terminated
Facility Name
Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrico Cortesi, MD
Phone
+39 064462982
Email
enricocortesi@uniroma1.it
First Name & Middle Initial & Last Name & Degree
Enrico Cortesi, MD
Facility Name
Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia Longo, MD
Phone
+39 0649970273
Email
flavia.longo@uniroma1.it
First Name & Middle Initial & Last Name & Degree
Flavia Longo, MD
Facility Name
S. Giovanni - Addolorata Hospital
City
Roma
ZIP/Postal Code
00184
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Mauri, MD
Phone
+39 0677052929
Email
mariella.mauri@libero.it
First Name & Middle Initial & Last Name & Degree
Maria Mauri, MD
Facility Name
Azienda Ospedaliera S. Giovanni di Dio e Ruggi d'Aragona
City
Salerno
ZIP/Postal Code
84122
Country
Italy
Individual Site Status
Terminated
Facility Name
Ospedale Civile SS. Annunziata
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Contu, MD
Phone
+39 0792061638
Email
antoncontu@tiscali.it
First Name & Middle Initial & Last Name & Degree
Antonio Contu, MD
Facility Name
Universita' di Sassari Oncologia Medica
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Farris, MD
Phone
0039.079228382
Email
afarris@uniss.it
First Name & Middle Initial & Last Name & Degree
Antonio Farris, MD
Facility Name
Ospedale Morelli
City
Sondrio
ZIP/Postal Code
23035
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Valmadre, MD
Phone
0039.0342808322
Email
giuseppe.valmadre@aovv.it
First Name & Middle Initial & Last Name & Degree
Giuseppe Valmadre, MD
Facility Name
Sondrio Hospital-Azienda Ospedaliera Valtellina e Valchiavenna
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Bertolini, MD
Phone
+39 0342521594
Email
abertolini@tiscalinet.it
First Name & Middle Initial & Last Name & Degree
Alessandro Bertolini, MD
Facility Name
A.O.U. San Giovanni Battista Molinette
City
Torino
ZIP/Postal Code
10134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Libero Ciuffreda, MD
Phone
0039.0116334250
Email
lciuffreda@molinette.piemonte.it
First Name & Middle Initial & Last Name & Degree
Libero Ciuffreda, MD
Facility Name
Ospedale di Circolo
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Terminated
Facility Name
SS. Giovanni e Paolo Hospital
City
Venezia
ZIP/Postal Code
30122
Country
Italy
Individual Site Status
Terminated
Facility Name
San Bartolo Hospital
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Belcolle Hospital
City
Viterbo
ZIP/Postal Code
01100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Moscetti, MD
Phone
+39 0761339040
Email
l.moscetti@asl.vt.it
First Name & Middle Initial & Last Name & Degree
Luca Moscetti, MD

12. IPD Sharing Statement

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