Colorectal CancerNCT01830647
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 1 site in Montenegro.
Trial summary
This prospective observational study will evaluate the safety and efficacy of first-line Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice in patients with metastatic cancer of the colon and/or rectum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 35 participants
- Where
- 1 siteMontenegro
- Study dates
- Apr 2013to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic cancer of the colon and/or rectum
Who may be able to join
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases
- At least one measurable metastatic lesion (as per RECIST criteria)
- Life expectancy of > 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematological, renal and liver function
Who cannot join
- Prior chemotherapy for metastatic disease
- Clinically significant cardiovascular disease
- Ongoing treatment with aspirin (325 mg/day) or other medications known to predispose for gastrointestinal ulceration
- Participation in an investigational trial in the previous 3 months
- Pregnant or lactating women
- History of thrombotic or haemorrhagic disorders
Show all 10Show fewer
- Evidence of bleeding diathesis or coagulopathy
- Uncontrolled hypertension
- Known hypersensitivity to Avastin and any of its excipients, or any of the chemotherapies
- Evidence of any disease or disorder that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Bevacizumab in Combination With Standard Chemotherapy Regimens as First Line in Patients With Metastatic Cancer of the Colon or the Rectum
This prospective observational study will evaluate the safety and efficacy of first-line Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for the duration of their treatment and a 30-day follow-up after the last dose of study drug.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: approximately 3.5 years
Secondary outcomes (1)
Efficacy: Time to disease progression
Measured: approximately 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830647
- Sponsor's protocol ID
- ML28411
- Status last verified
- Nov 2016
- First submitted
- 10 Apr 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Bevacizumab in Combination With Standard Chemotherapy Regimens as First Line in Patients With Metastatic Cancer of the Colon or the Rectum
- ClinicalTrials.gov ID
- NCT01830647
- Acronym / sponsor ID
- ML28411
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study will evaluate the safety and efficacy of first-line Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for the duration of their treatment and a 30-day follow-up after the last dose of study drug.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic cancer of the colon and/or rectum
Key inclusion criteria (6 listed)
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases
- At least one measurable metastatic lesion (as per RECIST criteria)
- Life expectancy of > 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (10 listed)
- Prior chemotherapy for metastatic disease
- Clinically significant cardiovascular disease
- Ongoing treatment with aspirin (325 mg/day) or other medications known to predispose for gastrointestinal ulceration
- Participation in an investigational trial in the previous 3 months
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety: Incidence of adverse events
Time frame: approximately 3.5 years
1 secondary outcome
Efficacy: Time to disease progression
Time frame: approximately 3.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 1 site in Montenegro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Montenegro. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence of adverse events (time frame: approximately 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.