An Observational Study of Avastin (Bevacizumab) in Patien... | NCT01266564

Studies
An Observational Study of Avastin (Bevacizumab) in Patients With Colorectal Cancer

NCT01266564

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Aug 11, 2017Actual

Enrollment

205Actual

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Not provided

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 3, 2010Actual

Primary Completion Date

Jul 10, 2015Actual

Completion Date

Jul 10, 2015Actual

First Submitted Date

Dec 20, 2010

First Submission Date that Met QC Criteria

Dec 20, 2010

First Posted Date

Dec 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2017

Last Update Posted Date

Aug 11, 2017Actual

Description Module

Brief Summary

This observational study will assess the progression-free survival, overall response and safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in patients with metastatic colorectal cancer. Data will be collected from patients for approximately 2 years.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

205Actual

Label	Type	Description	Intervention Names
Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival in a real life setting assessed by computer tomography		Approximately 2 years

Secondary Outcomes

Measure	Description	Time Frame
Overall response rate assessed by computer tomography		Approximately 2 years
Response of Avastin according to the sites of metastases assessed by computer tomography		Approximately 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients, age >/=18 years
Proven metastatic colorectal carcinoma
Patients have measurable disease
Patients are eligible to receive first-line Avastin
Patients have signed data release form

Exclusion Criteria:

Contra-indication to receive Avastin according to the local labeling
Participation in a clinical study within 30 days prior to enrolment
Patients have any other primary cancer
Concomitant treatment with other biologics
History of other malignant disease in the past 5 years except basal cell carcinoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Colorectal cancer patients receiving Avastin in combination with chemotherapy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
American University of Beirut - Medical Center		Beirut		11-236	Lebanon
Saint George Hospital; Haematology-Oncology

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided