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Combination Chemotherapy and Bevacizumab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer (TRIBE)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
bevacizumab
fluorouracil
irinotecan hydrochloride
leucovorin calcium
oxaliplatin
Sponsored by
Gruppo Oncologico del Nord-Ovest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV rectal cancer, stage IV colon cancer, stage III rectal cancer, stage III colon cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal cancer

    • Unresectable metastatic disease
  • Measurable disease, defined as ≥ 1 measurable lesion according to RECIST criteria
  • No prior chemotherapy for metastatic disease
  • No untreated brain metastases, spinal cord compression, or primary brain tumors
  • No history or evidence of CNS disease by physical examination unless adequately treated (e.g., uncontrolled seizure despite standard medical therapy or history of stroke)

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status (PS) 0-2 (≤ 70 years of age) OR ECOG PS 0 (71-75 years of age)
  • Life expectancy ≥ 12 weeks
  • Neutrophils ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin > 9 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if f liver metastases present)
  • Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present)
  • Creatinine clearance > 50 mL/min OR serum creatinine ≤ 1.5 times ULN
  • Proteinuria < 2+ by dipstick OR urine protein ≤ 1 g by 24-hr urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Exclusion criteria:

  • Serious, nonhealing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis or coagulopathy
  • Uncontrolled hypertension

  • Clinically significant (i.e., active) cardiovascular disease, including any of the following:

    • Cerebrovascular accidents within the past 6 months
    • Myocardial infarction within the past 6 months
    • Unstable angina
    • New York Heart Association class II-IV congestive heart failure
    • Serious cardiac arrhythmia requiring medication
  • Known allergy to Chinese hamster ovary cell proteins or any of the components of the study medications
  • Other co-existing malignancy or malignancy diagnosed within the past 5 years, except for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix
  • Symptomatic peripheral neuropathy ≥ grade 1 according to the NCI Common Toxicity Criteria
  • Lack of physical integrity of the upper gastrointestinal tract
  • Malabsorption syndrome
  • Inability to take oral medication
  • Significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • More than 10 days since prior and no concurrent ongoing treatment with anticoagulants for therapeutic purposes
  • More than 28 days since prior and no concurrent major surgical procedure
  • More than 28 days since prior open biopsy
  • More than 30 days since prior investigational agents
  • No concurrent chronic daily high-dose acetylsalicylic acid (> 325 mg/day)

Sites / Locations

  • Ospedale Civile Ss. Antonio E Biagio Di Alessandria - Alessandria (Al) Oncologia Medica
  • A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona - Ancona (An) Oncologia Medica
  • P.O. Zona Aretina - Ospedale S. Donato Di Arezzo - Arezzo (Ar) Oncologia Medica
  • Irccs Centro Di Riferimento Oncologico (Cro) - Aviano (Pn) Oncologia Medica
  • Ospedale S. Orsola F.B.F. - Brescia - Brescia (Bs) Oncologia Medica
  • Istituto Ospedaliero Fondazione Poliambulanza Di Brescia - Brescia (Bs) Oncologia Medica
  • Stabilimento "Perrino" - Brindisi - Brindisi (Br) Oncologia Medica
  • Azienda Ospedaliera S. Elia - Caltanissetta (Cl) Oncologia Medica
  • Ausl 1 Di Massa E Carrara - Carrara (Ms) Oncologia Medica
  • Ospedale Cecina - Cecina (Li) Oncologia Medica
  • Istituti Ospitalieri - Cremona - Cremona (Cr) Oncologia Medica
  • Azienda Ospedaliera S. Croce E Carle Di Cuneo - Cuneo (Cn) Oncoematologia
  • Ausl 11 Di Empoli (Fi) - Empoli (Fi) Oncologia Medica
  • U.S.L.N.6 -Ospedale Civile 'E.Profili'-F - Fabriano (An) Oncologia Medica
  • Ausl 10 Di Firenze - Firenze (Fi) Oncologia Medica
  • Irccs Istituto Nazionale Per La Ricerca Sul Cancro (Ist) - Genova (Ge) Oncologia Medica
  • Ausl Le Di Lecce - Lecce (Le) Oncologia Medica
  • Aulss 21 Di Legnago (Vr) - Legnago (Vr) Oncologia Medica
  • Ausl 12 Di Viareggio (Lu) - Lido Di Camaiore (Lu) Oncologia Medica
  • Ospedale Livorno - Livorno (Li), Oncologia Medica
  • Presidio Ospedaliero Piana Di Lucca - Lucca (Lu) Oncologia Medica
  • Irccs Fondazione Centro S. Raffaele Del Monte Tabor - Milano (Mi) Oncologia Medica
  • Ospedale Ca' Granda-Niguarda - Milano - Milano (Mi) Oncologia Medica
  • S.Gerardo - Monza - Monza (Mi) Oncologia Medica
  • A.O. Universitaria Federico Ii Di Napoli Oncologia Medica
  • A.O. Universitaria Maggiore Della Carita' Di Novara Oncologia Medica
  • A.O. Universitaria Di Parma Oncologia Medica
  • Asl 1 Di Citta' Di Castello (Pg) - Citta' Di Castello (Pg) Oncologia Medica
  • A.O. Di Perugia - Ospedale S. Maria Della Misericordia (Ex Silvestrini) - Perugia (Pg) Oncologia Medica
  • Azienda Ospedaliera San Salvatore - Pesaro (Pu) Oncologia Medica
  • Ospedale Della Valdinievole - Pescia (Pt) Oncologia Medica
  • Ospedale Piombino - Piombino (Li) Oncologia Medica
  • A.O. Universitaria Pisana Oncologia Medica
  • Ausl 5 Di Pisa - Pisa (Pi) Oncologia Medica
  • Alfredo Falcone A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica
  • Ausl 3 Di Pistoia - Pistoia (Pt) Oncologia Medica
  • Ausl 4 Di Prato - Prato (Po) Oncologia Medica
  • Ospedale Di S. Maria Nuova - Reggio Nell'Emilia (Re) Oncologia Medica
  • Policlinico Universitario Campus Bio-Medico Di Roma Oncologia Medica
  • Policlinico Umberto I Di Roma Oncologia Medica
  • Policlinico Universitario Gemelli Di Roma Oncologia Medica
  • A.O. Universitaria Senese Oncologia Medica
  • Ospedale Civile - Sondrio - Sondrio (So) Oncologia Medica
  • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Oncologia Medica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (FOLFOXIRI)

Arm II (FOLFIRI)

Arm Description

Patients receive irinotecan hydrochloride IV over 1 hour, oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV on day 1. Patients also receive fluorouracil IV continuously over 48 hours beginning on day 1.

Patients receive irinotecan hydrochloride IV over 1 hour, leucovorin calcium IV over 2 hours, and bevacizumab IV on day 1. Patients also receive fluorouracil IV continuously over 48 hours beginning on day 1.

Outcomes

Primary Outcome Measures

Progression free survival
To compare the progression free survival of bevacizumab in combination with oxaliplatin, irinotecan and infusional 5FU/LV ("GONO" FOLFOXIRI regimen) to bevacizumab in combination with irinotecan and infusional 5FU/LV (FOLFIRI regimen)

Secondary Outcome Measures

Overall response rate
Duration of response
Secondary R0 surgery rates of metastases
Overall survival
Surrogate markers predictive of bevacizumab activity

Full Information

First Posted
July 19, 2008
Last Updated
March 10, 2015
Sponsor
Gruppo Oncologico del Nord-Ovest
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1. Study Identification

Unique Protocol Identification Number
NCT00719797
Brief Title
Combination Chemotherapy and Bevacizumab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
Acronym
TRIBE
Official Title
A PHASE III RANDOMIZED TRIAL OF FOLFOXIRI + BEVACIZUMAB VERSUS FOLFIRI + BEVACIZUMAB AS FIRST- LINE TREATMENT FOR METASTATIC COLORECTAL CANCER
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Oncologico del Nord-Ovest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens given together with bevacizumab to see how well they work as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES: Primary To compare the progression-free survival of bevacizumab in combination with oxaliplatin, irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFOXIRI) versus bevacizumab in combination with irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI) in patients with unresectable, metastatic colorectal cancer. Secondary To evaluate the safety profile, including long-term adverse events of these regimens in these patients. To compare the overall response rate, duration of response, and secondary R0 surgery rates of metastases and overall survival between treatment arms. To evaluate potential surrogate markers predictive of bevacizumab activity. OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1-2), prior adjuvant chemotherapy (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms. Arm I (FOLFOXIRI): Patients receive irinotecan hydrochloride IV over 1 hour, oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV on day 1. Patients also receive fluorouracil IV continuously over 48 hours beginning on day 1. Arm II (FOLFIRI): Patients receive irinotecan hydrochloride IV over 1 hour, leucovorin calcium IV over 2 hours, and bevacizumab IV on day 1. Patients also receive fluorouracil IV continuously over 48 hours beginning on day 1. In both arms, treatment repeats every 2 weeks for up to 12 courses. Treatment with bevacizumab, fluorouracil, and leucovorin calcium continues in the absence of disease progression or unacceptable toxicity. Patients undergo serum extraction and blood sample collection periodically for genotyping studies. Patients also undergo collection of tumoral sections from paraffin embedded primary and/or metastatic lesions periodically for immunohistochemical analyses. After completion of study treatment, patients are followed every 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV rectal cancer, stage IV colon cancer, stage III rectal cancer, stage III colon cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm I (FOLFOXIRI)
Arm Type
Experimental
Arm Description
Patients receive irinotecan hydrochloride IV over 1 hour, oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV on day 1. Patients also receive fluorouracil IV continuously over 48 hours beginning on day 1.
Arm Title
Arm II (FOLFIRI)
Arm Type
Experimental
Arm Description
Patients receive irinotecan hydrochloride IV over 1 hour, leucovorin calcium IV over 2 hours, and bevacizumab IV on day 1. Patients also receive fluorouracil IV continuously over 48 hours beginning on day 1.
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Progression free survival
Description
To compare the progression free survival of bevacizumab in combination with oxaliplatin, irinotecan and infusional 5FU/LV ("GONO" FOLFOXIRI regimen) to bevacizumab in combination with irinotecan and infusional 5FU/LV (FOLFIRI regimen)
Time Frame
up to 54 months
Secondary Outcome Measure Information:
Title
Overall response rate
Time Frame
up to 54 months
Title
Duration of response
Time Frame
up to 54 months
Title
Secondary R0 surgery rates of metastases
Time Frame
up to 54 months
Title
Overall survival
Time Frame
up to 54 months
Title
Surrogate markers predictive of bevacizumab activity
Time Frame
up to 54 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed colorectal cancer Unresectable metastatic disease Measurable disease, defined as ≥ 1 measurable lesion according to RECIST criteria No prior chemotherapy for metastatic disease No untreated brain metastases, spinal cord compression, or primary brain tumors No history or evidence of CNS disease by physical examination unless adequately treated (e.g., uncontrolled seizure despite standard medical therapy or history of stroke) PATIENT CHARACTERISTICS: Inclusion criteria: ECOG performance status (PS) 0-2 (≤ 70 years of age) OR ECOG PS 0 (71-75 years of age) Life expectancy ≥ 12 weeks Neutrophils ≥ 1.5 x 10^9/L Platelet count ≥ 100 x 10^9/L Hemoglobin > 9 g/dL Total bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if f liver metastases present) Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present) Creatinine clearance > 50 mL/min OR serum creatinine ≤ 1.5 times ULN Proteinuria < 2+ by dipstick OR urine protein ≤ 1 g by 24-hr urine collection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Exclusion criteria: Serious, nonhealing wound, ulcer, or bone fracture Evidence of bleeding diathesis or coagulopathy Uncontrolled hypertension Clinically significant (i.e., active) cardiovascular disease, including any of the following: Cerebrovascular accidents within the past 6 months Myocardial infarction within the past 6 months Unstable angina New York Heart Association class II-IV congestive heart failure Serious cardiac arrhythmia requiring medication Known allergy to Chinese hamster ovary cell proteins or any of the components of the study medications Other co-existing malignancy or malignancy diagnosed within the past 5 years, except for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix Symptomatic peripheral neuropathy ≥ grade 1 according to the NCI Common Toxicity Criteria Lack of physical integrity of the upper gastrointestinal tract Malabsorption syndrome Inability to take oral medication Significant traumatic injury within the past 28 days PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 4 weeks since prior radiotherapy More than 10 days since prior and no concurrent ongoing treatment with anticoagulants for therapeutic purposes More than 28 days since prior and no concurrent major surgical procedure More than 28 days since prior open biopsy More than 30 days since prior investigational agents No concurrent chronic daily high-dose acetylsalicylic acid (> 325 mg/day)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo Falcone, MD
Organizational Affiliation
Presidio Ospedaliero di Livorno
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Civile Ss. Antonio E Biagio Di Alessandria - Alessandria (Al) Oncologia Medica
City
Alessandria
ZIP/Postal Code
15100
Country
Italy
Facility Name
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona - Ancona (An) Oncologia Medica
City
Ancona
ZIP/Postal Code
60100
Country
Italy
Facility Name
P.O. Zona Aretina - Ospedale S. Donato Di Arezzo - Arezzo (Ar) Oncologia Medica
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Irccs Centro Di Riferimento Oncologico (Cro) - Aviano (Pn) Oncologia Medica
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Ospedale S. Orsola F.B.F. - Brescia - Brescia (Bs) Oncologia Medica
City
Brescia
ZIP/Postal Code
25122
Country
Italy
Facility Name
Istituto Ospedaliero Fondazione Poliambulanza Di Brescia - Brescia (Bs) Oncologia Medica
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Facility Name
Stabilimento "Perrino" - Brindisi - Brindisi (Br) Oncologia Medica
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Facility Name
Azienda Ospedaliera S. Elia - Caltanissetta (Cl) Oncologia Medica
City
Caltanissetta
ZIP/Postal Code
93100
Country
Italy
Facility Name
Ausl 1 Di Massa E Carrara - Carrara (Ms) Oncologia Medica
City
Carrara
ZIP/Postal Code
54033
Country
Italy
Facility Name
Ospedale Cecina - Cecina (Li) Oncologia Medica
City
Cecina
ZIP/Postal Code
57023
Country
Italy
Facility Name
Istituti Ospitalieri - Cremona - Cremona (Cr) Oncologia Medica
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Azienda Ospedaliera S. Croce E Carle Di Cuneo - Cuneo (Cn) Oncoematologia
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Ausl 11 Di Empoli (Fi) - Empoli (Fi) Oncologia Medica
City
Empoli
ZIP/Postal Code
50053
Country
Italy
Facility Name
U.S.L.N.6 -Ospedale Civile 'E.Profili'-F - Fabriano (An) Oncologia Medica
City
Fabriano
ZIP/Postal Code
60044
Country
Italy
Facility Name
Ausl 10 Di Firenze - Firenze (Fi) Oncologia Medica
City
Firenze
ZIP/Postal Code
50122
Country
Italy
Facility Name
Irccs Istituto Nazionale Per La Ricerca Sul Cancro (Ist) - Genova (Ge) Oncologia Medica
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ausl Le Di Lecce - Lecce (Le) Oncologia Medica
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Aulss 21 Di Legnago (Vr) - Legnago (Vr) Oncologia Medica
City
Legnano
ZIP/Postal Code
37045
Country
Italy
Facility Name
Ausl 12 Di Viareggio (Lu) - Lido Di Camaiore (Lu) Oncologia Medica
City
Lido di Camaiore
ZIP/Postal Code
55053
Country
Italy
Facility Name
Ospedale Livorno - Livorno (Li), Oncologia Medica
City
Livorno
ZIP/Postal Code
57100
Country
Italy
Facility Name
Presidio Ospedaliero Piana Di Lucca - Lucca (Lu) Oncologia Medica
City
Lucca
ZIP/Postal Code
25124
Country
Italy
Facility Name
Irccs Fondazione Centro S. Raffaele Del Monte Tabor - Milano (Mi) Oncologia Medica
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ospedale Ca' Granda-Niguarda - Milano - Milano (Mi) Oncologia Medica
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
S.Gerardo - Monza - Monza (Mi) Oncologia Medica
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
A.O. Universitaria Federico Ii Di Napoli Oncologia Medica
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O. Universitaria Maggiore Della Carita' Di Novara Oncologia Medica
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
A.O. Universitaria Di Parma Oncologia Medica
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Asl 1 Di Citta' Di Castello (Pg) - Citta' Di Castello (Pg) Oncologia Medica
City
Perugia
ZIP/Postal Code
06012
Country
Italy
Facility Name
A.O. Di Perugia - Ospedale S. Maria Della Misericordia (Ex Silvestrini) - Perugia (Pg) Oncologia Medica
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Azienda Ospedaliera San Salvatore - Pesaro (Pu) Oncologia Medica
City
Pesaro
ZIP/Postal Code
61100
Country
Italy
Facility Name
Ospedale Della Valdinievole - Pescia (Pt) Oncologia Medica
City
Pescia
ZIP/Postal Code
51017
Country
Italy
Facility Name
Ospedale Piombino - Piombino (Li) Oncologia Medica
City
Piombino
ZIP/Postal Code
57100
Country
Italy
Facility Name
A.O. Universitaria Pisana Oncologia Medica
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Ausl 5 Di Pisa - Pisa (Pi) Oncologia Medica
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Alfredo Falcone A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ausl 3 Di Pistoia - Pistoia (Pt) Oncologia Medica
City
Pistoia
ZIP/Postal Code
51100
Country
Italy
Facility Name
Ausl 4 Di Prato - Prato (Po) Oncologia Medica
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
Ospedale Di S. Maria Nuova - Reggio Nell'Emilia (Re) Oncologia Medica
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico Di Roma Oncologia Medica
City
Rome
ZIP/Postal Code
00155
Country
Italy
Facility Name
Policlinico Umberto I Di Roma Oncologia Medica
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Policlinico Universitario Gemelli Di Roma Oncologia Medica
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O. Universitaria Senese Oncologia Medica
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Ospedale Civile - Sondrio - Sondrio (So) Oncologia Medica
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Facility Name
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Oncologia Medica
City
Torino
ZIP/Postal Code
10134
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
35594613
Citation
Rossini D, Germani MM, Lonardi S, Pietrantonio F, Dell'Aquila E, Borelli B, Allegrini G, Maddalena G, Randon G, Marmorino F, Zaniboni A, Buonadonna A, Boccaccino A, Conca V, Antoniotti C, Passardi A, Masi G, Cremolini C. Treatments after second progression in metastatic colorectal cancer: A pooled analysis of the TRIBE and TRIBE2 studies. Eur J Cancer. 2022 Jul;170:64-72. doi: 10.1016/j.ejca.2022.04.019. Epub 2022 May 17.
Results Reference
derived
PubMed Identifier
35366570
Citation
Antoniotti C, Germani MM, Rossini D, Lonardi S, Pietrantonio F, Santini D, Marmorino F, Allegrini G, Daniel F, Raimondi A, Borelli B, Zaniboni A, Conca V, Abraham J, Spetzler D, Maiello E, Boccaccino A, Passardi A, Giordano M, Tamburini E, Korn MW, Masi G, Cremolini C. FOLFOXIRI and bevacizumab in patients with early-onset metastatic colorectal cancer. A pooled analysis of TRIBE and TRIBE2 studies. Eur J Cancer. 2022 May;167:23-31. doi: 10.1016/j.ejca.2022.02.031. Epub 2022 Mar 30.
Results Reference
derived
PubMed Identifier
32816630
Citation
Cremolini C, Antoniotti C, Stein A, Bendell J, Gruenberger T, Rossini D, Masi G, Ongaro E, Hurwitz H, Falcone A, Schmoll HJ, Di Maio M. Individual Patient Data Meta-Analysis of FOLFOXIRI Plus Bevacizumab Versus Doublets Plus Bevacizumab as Initial Therapy of Unresectable Metastatic Colorectal Cancer. J Clin Oncol. 2020 Aug 20:JCO2001225. doi: 10.1200/JCO.20.01225. Online ahead of print.
Results Reference
derived
PubMed Identifier
30293873
Citation
Tokunaga R, Cao S, Naseem M, Lo JH, Battaglin F, Puccini A, Berger MD, Soni S, Millstein J, Zhang W, Stintzing S, Loupakis F, Cremolini C, Heinemann V, Falcone A, Lenz HJ. Prognostic Effect of Adenosine-related Genetic Variants in Metastatic Colorectal Cancer Treated With Bevacizumab-based Chemotherapy. Clin Colorectal Cancer. 2019 Mar;18(1):e8-e19. doi: 10.1016/j.clcc.2018.09.003. Epub 2018 Sep 13.
Results Reference
derived
PubMed Identifier
29873679
Citation
Cremolini C, Antoniotti C, Lonardi S, Bergamo F, Cortesi E, Tomasello G, Moretto R, Ronzoni M, Racca P, Loupakis F, Zaniboni A, Tonini G, Buonadonna A, Marmorino F, Allegrini G, Granetto C, Masi G, Zagonel V, Sensi E, Fontanini G, Boni L, Falcone A. Primary tumor sidedness and benefit from FOLFOXIRI plus bevacizumab as initial therapy for metastatic colorectal cancer. Retrospective analysis of the TRIBE trial by GONO. Ann Oncol. 2018 Jul;29(7):1528-1534. doi: 10.1093/annonc/mdy140. Epub 2018 Apr 20.
Results Reference
derived
PubMed Identifier
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Combination Chemotherapy and Bevacizumab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

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