Colorectal CancerNCT01591109
A Reversal in the Vascularity of Metastatic Liver Tumors From Colorectal Cancer After the Cessation of Anti-VEGF Therapy
An observational study of Colorectal Cancer, run by NHO - Matsumoto Medical Center.
Trial summary
Objective: To assess the effect of bevacizumab on tumor vessels, and the reversibility of the effect, using contrast-enhanced ultrasonography (CEUS) and histology in patients with metastatic liver tumors derived from colorectal cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Apr 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents cared by the institution this study was perfomed.
Who may be able to join
- patients who received chemotherapy (FOLFOX) including bevacizumab. The patients had an associated reduction in tumor vascularity as estimated by ultrasonography and consequently underwent surgical resection of the metastatic liver tumors for curative purposes.
Who cannot join
- none
About this study
Official title: A Reversal in the Vascularity of Metastatic Liver Tumors in Patients With Colorectal Cancer After the Cessation of Anti-VEGF Therapy: A Study Using Contrast-enhanced Ultrasonography and Histological Techniques.
Objective: To assess the effect of bevacizumab on tumor vessels, and the reversibility of the effect, using contrast-enhanced ultrasonography (CEUS) and histology in patients with metastatic liver tumors derived from colorectal cancer.
Background Data: Direct evidence on the reversibility of any change in tumor vascularity upon bevacizumab cessation in the clinical setting is lacking.
Methods: The study included 10 patients who received chemotherapy including bevacizumab, experienced a reduction in tumor vascularity as demonstrated by CEUS and consequently underwent liver resection. CEUS was performed before and immediately after 4 courses of chemotherapy and one day before surgery. The number of microvessels highlighted by anti-CD34 antibody in the viable tumor tissue was counted to quantify the microvessel density (MVD). As a control, 10 surgical specimens from 10 patients who had not received chemotherapy were examined.
- 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 |
|---|---|---|
| Bevacizumab including chemotherapy | Patients treated with bevacizumab including chemotherapy for metastatic liver tumor derived from colorectal cancer before metastasectomy. | |
| no adjuvant chemotherapy | Patients with no adjuvant chemotherapy including bevacizumab |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startJan 2010
- Primary completionApr 2012
- Study completionApr 2012
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.
- 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
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHO - Matsumoto Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hiroshi Kitamura, NHO - Matsumoto Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591109
- Sponsor's protocol ID
- 24-1
- Status last verified
- May 2012
- First submitted
- 2 May 2012
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reversal in the Vascularity of Metastatic Liver Tumors in Patients With Colorectal Cancer After the Cessation of Anti-VEGF Therapy: A Study Using Contrast-enhanced Ultrasonography and Histological Techniques.
- ClinicalTrials.gov ID
- NCT01591109
- Acronym / sponsor ID
- 24-1
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NHO - Matsumoto Medical CenterOther government
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 May 2012 (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.
Objective: To assess the effect of bevacizumab on tumor vessels, and the reversibility of the effect, using contrast-enhanced ultrasonography (CEUS) and histology in patients with metastatic liver tumors derived from colorectal cancer.
Background Data: Direct evidence on the reversibility of any change in tumor vascularity upon bevacizumab cessation in the clinical setting is lacking.
Methods: The study included 10 patients who received chemotherapy including bevacizumab, experienced a reduction in tumor vascularity as demonstrated by CEUS and consequently underwent liver resection. CEUS was performed before and immediately after 4 courses of chemotherapy and one day before surgery. The number of microvessels highlighted by anti-CD34 antibody in the viable tumor tissue was counted to quantify the microvessel density (MVD). As a control, 10 surgical specimens from 10 patients who had not received chemotherapy were examined.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab including chemotherapy | – | –Patients treated with bevacizumab including chemotherapy for metastatic liver tumor derived from colorectal cancer before metastasectomy. |
| no adjuvant chemotherapy | – | –Patients with no adjuvant chemotherapy including bevacizumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents cared by the institution this study was perfomed.
Key inclusion criteria (1 listed)
- patients who received chemotherapy (FOLFOX) including bevacizumab. The patients had an associated reduction in tumor vascularity as estimated by ultrasonography and consequently underwent surgical resection of the metastatic liver tumors for curative purposes.
Key exclusion criteria (1 listed)
- none
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
Not reported in the source record.
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 3 May 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by NHO - Matsumoto Medical Center.
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 1 inclusion and 1 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 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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 3 May 2012.