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A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Chemotherapy
Bevacizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients, >=18 years of age
  • Metastatic colorectal cancer and disease progression
  • Previously treated with first-line chemotherapy plus Avastin
  • Eastern Cooperative Oncology Group (ECOG) performance status <=2.

Exclusion Criteria:

  • Diagnosis of progression of disease more than 3 months after last Avastin administration
  • First-line patients with progression-free survival in first-line of <3 months
  • Patients receiving less than 3 consecutive months of Avastin in first-line therapy
  • Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix
  • Clinically significant cardiovascular disease within 6 months prior to start of study treatment
  • Known central nervous system (CNS) disease, except for treated CNS metastases as defined by protocol

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemotherapy

Chemotherapy + Bevacizumab

Arm Description

Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal

Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal

Outcomes

Primary Outcome Measures

Overall Survival: Time From Randomization to Death From Any Cause

Secondary Outcome Measures

Overall Survival: Months From Time of First Line Therapy
Participants With Progression Free Survival Event
Progression Free Survival: Time to Event
Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria
Response Rate: Participants With Response Status Based on RECIST Criteria
Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.

Full Information

First Posted
June 17, 2008
Last Updated
July 2, 2015
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00700102
Brief Title
A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
Official Title
A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
Arm Title
Chemotherapy + Bevacizumab
Arm Type
Experimental
Arm Description
Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
As prescribed
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.
Primary Outcome Measure Information:
Title
Overall Survival: Time From Randomization to Death From Any Cause
Time Frame
within 6.5 years
Secondary Outcome Measure Information:
Title
Overall Survival: Months From Time of First Line Therapy
Time Frame
within approximately 9.6 years
Title
Participants With Progression Free Survival Event
Time Frame
within 6.5 years
Title
Progression Free Survival: Time to Event
Time Frame
within 6.5 years
Title
Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria
Time Frame
within 6.5 years
Title
Response Rate: Participants With Response Status Based on RECIST Criteria
Description
Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
Time Frame
within 6.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients, >=18 years of age Metastatic colorectal cancer and disease progression Previously treated with first-line chemotherapy plus Avastin Eastern Cooperative Oncology Group (ECOG) performance status <=2. Exclusion Criteria: Diagnosis of progression of disease more than 3 months after last Avastin administration First-line patients with progression-free survival in first-line of <3 months Patients receiving less than 3 consecutive months of Avastin in first-line therapy Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix Clinically significant cardiovascular disease within 6 months prior to start of study treatment Known central nervous system (CNS) disease, except for treated CNS metastases as defined by protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Dornbirn
ZIP/Postal Code
6850
Country
Austria
City
Fürstenfeld
ZIP/Postal Code
8280
Country
Austria
City
Graz
ZIP/Postal Code
8020
Country
Austria
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Hall in Tirol
ZIP/Postal Code
6060
Country
Austria
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Krems
ZIP/Postal Code
3500
Country
Austria
City
Leoben
ZIP/Postal Code
8700
Country
Austria
City
Linz
ZIP/Postal Code
4020
Country
Austria
City
Rankweil
ZIP/Postal Code
6830
Country
Austria
City
Ried-innkreis
ZIP/Postal Code
4910
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
St Pölten
ZIP/Postal Code
3100
Country
Austria
City
St Veit An Der Glan
ZIP/Postal Code
9300
Country
Austria
City
Steyr
ZIP/Postal Code
4400
Country
Austria
City
Villach
ZIP/Postal Code
9500
Country
Austria
City
Waidhofen A D Thaya
ZIP/Postal Code
3830
Country
Austria
City
Wels
ZIP/Postal Code
4600
Country
Austria
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria
City
Wien
ZIP/Postal Code
1160
Country
Austria
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
City
Assebroek
ZIP/Postal Code
8310
Country
Belgium
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
City
Brno
ZIP/Postal Code
656 53
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
City
Praha
ZIP/Postal Code
180 81
Country
Czech Republic
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
City
Herning
ZIP/Postal Code
7400
Country
Denmark
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark
City
København
ZIP/Postal Code
2100
Country
Denmark
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
City
Oulu
ZIP/Postal Code
90029
Country
Finland
City
Tampere
ZIP/Postal Code
33520
Country
Finland
City
Turku
ZIP/Postal Code
20520
Country
Finland
City
Vaasa
ZIP/Postal Code
65130
Country
Finland
City
Agen
ZIP/Postal Code
47000
Country
France
City
Albi
ZIP/Postal Code
81030
Country
France
City
Amiens
ZIP/Postal Code
80090
Country
France
City
Amilly
ZIP/Postal Code
45200
Country
France
City
Antibes
ZIP/Postal Code
06600
Country
France
City
Antony
ZIP/Postal Code
92166
Country
France
City
Arras
ZIP/Postal Code
62000
Country
France
City
Avignon
ZIP/Postal Code
84918
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Beziers
ZIP/Postal Code
34525
Country
France
City
Bordeaux
ZIP/Postal Code
33075
Country
France
City
Bordeaux
ZIP/Postal Code
33077
Country
France
City
Bourgoin Jallieu
ZIP/Postal Code
38317
Country
France
City
Caen
ZIP/Postal Code
14033
Country
France
City
Cahors
ZIP/Postal Code
46005
Country
France
City
Chambray Les Tours
ZIP/Postal Code
37171
Country
France
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
City
Colmar
ZIP/Postal Code
68024
Country
France
City
Compiegne
ZIP/Postal Code
60321
Country
France
City
Dechy
ZIP/Postal Code
59187
Country
France
City
Dijon
ZIP/Postal Code
21079
Country
France
City
Grenoble
ZIP/Postal Code
38000
Country
France
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
City
La Seyne Sur Mer
ZIP/Postal Code
83500
Country
France
City
Lagny Sur Marne
ZIP/Postal Code
77405
Country
France
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
City
Le Mans
ZIP/Postal Code
72037
Country
France
City
Libourne
ZIP/Postal Code
33505
Country
France
City
Lille
ZIP/Postal Code
59020
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Limoges
ZIP/Postal Code
87042
Country
France
City
Lliie
ZIP/Postal Code
59003
Country
France
City
Longjumeau
ZIP/Postal Code
91161
Country
France
City
Lyon
ZIP/Postal Code
69317
Country
France
City
Lyon
ZIP/Postal Code
69337
Country
France
City
Lyon
ZIP/Postal Code
69373
Country
France
City
Macon
ZIP/Postal Code
71000
Country
France
City
Marseille
ZIP/Postal Code
13273
Country
France
City
Marseille
ZIP/Postal Code
13274
Country
France
City
Marseille
ZIP/Postal Code
13285
Country
France
City
Meaux
ZIP/Postal Code
77104
Country
France
City
Metz
ZIP/Postal Code
57038
Country
France
City
Mont De Marsan
ZIP/Postal Code
40024
Country
France
City
Montbeliard
ZIP/Postal Code
25209
Country
France
City
Montfermeil
ZIP/Postal Code
93370
Country
France
City
Montpellier
ZIP/Postal Code
34298
Country
France
City
Mougins
ZIP/Postal Code
6250
Country
France
City
Nancy
ZIP/Postal Code
54100
Country
France
City
Nantes
ZIP/Postal Code
44093
Country
France
City
Nantes
ZIP/Postal Code
44202
Country
France
City
Neuilly Sur Seine
ZIP/Postal Code
92200
Country
France
City
Nevers
ZIP/Postal Code
58033
Country
France
City
Nice
ZIP/Postal Code
06189
Country
France
City
Orleans
ZIP/Postal Code
45100
Country
France
City
Paris
ZIP/Postal Code
75571
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
Paris
ZIP/Postal Code
75674
Country
France
City
Paris
ZIP/Postal Code
75877
Country
France
City
Paris
ZIP/Postal Code
75908
Country
France
City
Paris
ZIP/Postal Code
75970
Country
France
City
Perigueux
ZIP/Postal Code
24000
Country
France
City
Pessac
ZIP/Postal Code
33604
Country
France
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
City
Pontoise
ZIP/Postal Code
95300
Country
France
City
Reims CEDEX
ZIP/Postal Code
51056
Country
France
City
Reims
ZIP/Postal Code
51092
Country
France
City
Rennes
ZIP/Postal Code
35033
Country
France
City
Rodez
ZIP/Postal Code
12027
Country
France
City
Rouen
ZIP/Postal Code
76031
Country
France
City
Saint Gregoire
ZIP/Postal Code
35768
Country
France
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
City
Senlis
ZIP/Postal Code
60309
Country
France
City
St Brieuc
ZIP/Postal Code
22027
Country
France
City
St Cloud
ZIP/Postal Code
92210
Country
France
City
Strasbourg
ZIP/Postal Code
67010
Country
France
City
Strasbourg
ZIP/Postal Code
67065
Country
France
City
Strasbourg
ZIP/Postal Code
67098
Country
France
City
Suresnes
ZIP/Postal Code
92151
Country
France
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
City
Verdun
ZIP/Postal Code
55107
Country
France
City
Aachen
ZIP/Postal Code
52064
Country
Germany
City
Aachen
ZIP/Postal Code
52074
Country
Germany
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
City
Bergisch Gladbach
ZIP/Postal Code
51429
Country
Germany
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Berlin
ZIP/Postal Code
10707
Country
Germany
City
Berlin
ZIP/Postal Code
13125
Country
Germany
City
Berlin
ZIP/Postal Code
13585
Country
Germany
City
Berlin
ZIP/Postal Code
14195
Country
Germany
City
Bietigheim
ZIP/Postal Code
74321
Country
Germany
City
Bochum
ZIP/Postal Code
44791
Country
Germany
City
Bochum
ZIP/Postal Code
44892
Country
Germany
City
Bonn
ZIP/Postal Code
53113
Country
Germany
City
Bremen
ZIP/Postal Code
28325
Country
Germany
City
Chemnitz
ZIP/Postal Code
09119
Country
Germany
City
Darmstadt
ZIP/Postal Code
64295
Country
Germany
City
Dessau-Roßlau
ZIP/Postal Code
06847
Country
Germany
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
City
Dresden
ZIP/Postal Code
01127
Country
Germany
City
Dresden
ZIP/Postal Code
01307
Country
Germany
City
Duisburg
ZIP/Postal Code
47166
Country
Germany
City
Erlangen
ZIP/Postal Code
97054
Country
Germany
City
Eschweiler
ZIP/Postal Code
52249
Country
Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
City
Flensburg
ZIP/Postal Code
24939
Country
Germany
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
City
Frechen
ZIP/Postal Code
50226
Country
Germany
City
Fulda
ZIP/Postal Code
36043
Country
Germany
City
Geilenkirchen
ZIP/Postal Code
52511
Country
Germany
City
Gifhorn
ZIP/Postal Code
38518
Country
Germany
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
City
Gummersbach
ZIP/Postal Code
51643
Country
Germany
City
Halle
ZIP/Postal Code
06120
Country
Germany
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
City
Hamburg
ZIP/Postal Code
22457
Country
Germany
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
City
Hannover
ZIP/Postal Code
30449
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
Heidenheim
ZIP/Postal Code
89522
Country
Germany
City
Hildesheim
ZIP/Postal Code
31135
Country
Germany
City
Hof
ZIP/Postal Code
95028
Country
Germany
City
Homburg/Saar
ZIP/Postal Code
66424
Country
Germany
City
Kassel
ZIP/Postal Code
34119
Country
Germany
City
Kassel
ZIP/Postal Code
34131
Country
Germany
City
Kronach
ZIP/Postal Code
96317
Country
Germany
City
Köln
ZIP/Postal Code
50677
Country
Germany
City
Köln
ZIP/Postal Code
50924
Country
Germany
City
Köln
ZIP/Postal Code
51103
Country
Germany
City
Köthen
ZIP/Postal Code
06366
Country
Germany
City
Laatzen
ZIP/Postal Code
30880
Country
Germany
City
Leer
ZIP/Postal Code
26789
Country
Germany
City
Lehrte
ZIP/Postal Code
31275
Country
Germany
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
City
Lemgo
ZIP/Postal Code
32657
Country
Germany
City
Leverkusen
ZIP/Postal Code
51375
Country
Germany
City
Limburg
ZIP/Postal Code
65549
Country
Germany
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
City
Magdeburg
ZIP/Postal Code
39130
Country
Germany
City
Magedburg
ZIP/Postal Code
39104
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Mannheim
ZIP/Postal Code
68165
Country
Germany
City
Marburg
ZIP/Postal Code
35043
Country
Germany
City
Marktredwitz
ZIP/Postal Code
95615
Country
Germany
City
Marl
ZIP/Postal Code
45768
Country
Germany
City
Moers
ZIP/Postal Code
47441
Country
Germany
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
City
Muenster
ZIP/Postal Code
48149
Country
Germany
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
City
Mülheim
ZIP/Postal Code
45468
Country
Germany
City
Neunkirchen/Saar
ZIP/Postal Code
66538
Country
Germany
City
Neustadt
ZIP/Postal Code
01844
Country
Germany
City
Nordhausen
ZIP/Postal Code
99734
Country
Germany
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
City
Olpe
ZIP/Postal Code
57462
Country
Germany
City
Pinneberg
ZIP/Postal Code
25421
Country
Germany
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
City
Remscheid
ZIP/Postal Code
42859
Country
Germany
City
Rostock
ZIP/Postal Code
18055
Country
Germany
City
Rostock
ZIP/Postal Code
18107
Country
Germany
City
Rotenburg
ZIP/Postal Code
27356
Country
Germany
City
Rötha
ZIP/Postal Code
04571
Country
Germany
City
Schwerin
ZIP/Postal Code
19057
Country
Germany
City
Schönebeck
ZIP/Postal Code
39218
Country
Germany
City
Stade
ZIP/Postal Code
21680
Country
Germany
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
City
Suhl
ZIP/Postal Code
98527
Country
Germany
City
Troisdorf
ZIP/Postal Code
53840
Country
Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
City
Velbert
ZIP/Postal Code
42551
Country
Germany
City
Wernigerode
ZIP/Postal Code
38855
Country
Germany
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
City
Wuerselen
ZIP/Postal Code
52146
Country
Germany
City
Amersfoort
ZIP/Postal Code
3818 ES
Country
Netherlands
City
Capelle a/d IJssel
ZIP/Postal Code
NL 2900 AR
Country
Netherlands
City
Leiden
ZIP/Postal Code
2334 CK
Country
Netherlands
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
City
Bergen
ZIP/Postal Code
5021
Country
Norway
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
City
Lorenskog
ZIP/Postal Code
1478
Country
Norway
City
Oslo
ZIP/Postal Code
0407
Country
Norway
City
Ålesund
ZIP/Postal Code
6026
Country
Norway
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
City
Lisboa
ZIP/Postal Code
1495-005
Country
Portugal
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
City
Dammam
ZIP/Postal Code
31444
Country
Saudi Arabia
City
Jeddah
ZIP/Postal Code
21497
Country
Saudi Arabia
City
Jeddah
ZIP/Postal Code
21589
Country
Saudi Arabia
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
City
Elda
State/Province
Alicante
ZIP/Postal Code
03600
Country
Spain
City
Torrevieja
State/Province
Alicante
ZIP/Postal Code
03186
Country
Spain
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Sant Cugat Del Valles
State/Province
Barcelona
ZIP/Postal Code
28981
Country
Spain
City
Cádiz
State/Province
Cadiz
ZIP/Postal Code
11009
Country
Spain
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20080
Country
Spain
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
City
Parla
State/Province
Madrid
ZIP/Postal Code
28981
Country
Spain
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
City
Alicante
ZIP/Postal Code
3010
Country
Spain
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
City
Barcelona
ZIP/Postal Code
08227
Country
Spain
City
Barcelona
ZIP/Postal Code
08906
Country
Spain
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
City
Burgos
ZIP/Postal Code
09006
Country
Spain
City
Castellon
ZIP/Postal Code
12002
Country
Spain
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
City
Girona
ZIP/Postal Code
17007
Country
Spain
City
Granada
ZIP/Postal Code
18014
Country
Spain
City
Huelva
ZIP/Postal Code
21005
Country
Spain
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
City
Lerida
ZIP/Postal Code
25198
Country
Spain
City
Madrid
ZIP/Postal Code
28002
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28943
Country
Spain
City
Murcia
ZIP/Postal Code
30008
Country
Spain
City
Navarra
ZIP/Postal Code
31008
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Valencia
ZIP/Postal Code
41014
Country
Spain
City
Valencia
ZIP/Postal Code
46015
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Valencia
ZIP/Postal Code
46026
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
City
Lund
ZIP/Postal Code
22185
Country
Sweden
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
City
Vaxjo
ZIP/Postal Code
35185
Country
Sweden
City
Aarau
ZIP/Postal Code
5000
Country
Switzerland
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Bern
ZIP/Postal Code
3011
Country
Switzerland
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
City
Luzern
ZIP/Postal Code
6004
Country
Switzerland
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
City
Zürich
ZIP/Postal Code
8038
Country
Switzerland
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23852309
Citation
Kubicka S, Greil R, Andre T, Bennouna J, Sastre J, Van Cutsem E, von Moos R, Osterlund P, Reyes-Rivera I, Muller T, Makrutzki M, Arnold D; ML18147 study investigators including AIO, GERCOR, FFCD, UNICANCER GI, TTD, BGDO, GEMCAD, and AGMT groups. Bevacizumab plus chemotherapy continued beyond first progression in patients with metastatic colorectal cancer previously treated with bevacizumab plus chemotherapy: ML18147 study KRAS subgroup findings. Ann Oncol. 2013 Sep;24(9):2342-9. doi: 10.1093/annonc/mdt231. Epub 2013 Jul 12.
Results Reference
derived
PubMed Identifier
23168366
Citation
Bennouna J, Sastre J, Arnold D, Osterlund P, Greil R, Van Cutsem E, von Moos R, Vieitez JM, Bouche O, Borg C, Steffens CC, Alonso-Orduna V, Schlichting C, Reyes-Rivera I, Bendahmane B, Andre T, Kubicka S; ML18147 Study Investigators. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol. 2013 Jan;14(1):29-37. doi: 10.1016/S1470-2045(12)70477-1. Epub 2012 Nov 16.
Results Reference
derived

Learn more about this trial

A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.

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