NCT01399190

Brief Summary

This prospective observational study will evaluate the efficacy and safety of bevacizumab in combination with capecitabine and oxaliplatin as first-line treatment in participants with colorectal cancer. Data will be collected from each participant until disease progression occurs (for up to 30 months).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

September 28, 2016

Completed
Last Updated

September 28, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

July 20, 2011

Results QC Date

August 4, 2016

Last Update Submit

August 4, 2016

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival

    Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.

    From randomization to progression or death during the study (up to approximately 30 months)

Secondary Outcomes (2)

  • Response Rate (Tumor Assessments According to RECIST)

    Up to approximately 30 months

  • Percentage of Participants With Adverse Events

    Up to approximately 30 months

Study Arms (1)

Bevacizumab

Participants will receive bevacizumab in combination with capecitabine and oxaliplatin.

Biological: BevacizumabBiological: CapecitabineDrug: Oxaliplatin

Interventions

BevacizumabBIOLOGICAL

Bevacizumab administered according to prescribing information and normal clinical practice.

Also known as: Avastin®
Bevacizumab
CapecitabineBIOLOGICAL

Capecitabine administered according to prescribing information and normal clinical practice.

Also known as: Xeloda®
Bevacizumab
OxaliplatinDRUG

Capecitabine administered according to prescribing information and normal clinical practice.

Also known as: Eloxatin™
Bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with colorectal cancer on first-line treatment with bevacizumab in combination with capecitabine and oxaliplatin.

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Metastatic colorectal cancer
  • Treatment in accordance with current Summary of Product Characteristics and local guidelines

You may not qualify if:

  • Contraindications according to current Summary of Product Characteristics and local guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Banská Bystrica, 975 17, Slovakia

Location

Unknown Facility

Bratislava, 812 50, Slovakia

Location

Unknown Facility

Bratislava, 833 10, Slovakia

Location

Unknown Facility

Košice, 04001, Slovakia

Location

Unknown Facility

Martin, 036 59, Slovakia

Location

Unknown Facility

Nitra, 950 01, Slovakia

Location

Unknown Facility

Poprad, 058 01, Slovakia

Location

Unknown Facility

Prešov, 081 81, Slovakia

Location

Unknown Facility

Ružomberok, 03426, Slovakia

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

BevacizumabCapecitabineOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic Chemicals

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800 821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2011

First Posted

July 21, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

September 28, 2016

Results First Posted

September 28, 2016

Record last verified: 2016-08

Locations

SL(9)