NCT01674907

Brief Summary

This observational study will evaluate the use in clinical practice and the efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer who have not received prior chemotherapy treatment in the metastatic setting. Patients for whom the treating physician has decided to initiate therapy with Avastin will be followed for 10 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Typical duration for all trials

Geographic Reach
1 country

5 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

March 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

August 22, 2012

Last Update Submit

November 1, 2016

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

  • Dosage/schedule of 1st-line Avastin

    approximately 3 years

  • Duration of treatment

    approximately 3 years

  • Chemotherapy regimens used in clinical practice

    approximately 3 years

  • Clinical/demographic patient characteristics at baseline

    approximately 3 years

Secondary Outcomes (2)

  • Progression-free survival

    approximately 3 years

  • Relationship between termination of Avastin treatment and time point of progression

    approximately 3 years

Study Arms (1)

Cohort

Eligibility Criteria

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

Patients with metastatic colorectal cancer without prior chemotherapy in the metastatic setting

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Histologically confirmed metastatic colorectal cancer without prior chemotherapy in the metastatic setting

You may not qualify if:

  • Contraindications for Avastin according to the locally approved package insert (version 7 April 2006)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Cape Town, 7500, South Africa

Location

Unknown Facility

George, 6529, South Africa

Location

Unknown Facility

Port Elizabeth, 6045, South Africa

Location

Unknown Facility

Pretoria, 0001, South Africa

Location

Unknown Facility

Vereeniging, 1939, South Africa

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 22, 2012

First Posted

August 29, 2012

Study Start

March 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

ZA(5)