Colorectal CancerMORENCT01815879
Metastatic Colorectal Cancer Liver Metastases Outcomes After Resin 90Y Microsphere Radioembolization in the USA Evaluation Project
An observational study of Colorectal Cancer and Liver Metastases, run by Andrew Kennedy at 1 site in United States.
Trial summary
Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Metastases
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2013
- 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 colorectal liver metastases in the USA treated with 90Y resin microsphere radioembolization
Who may be able to join
- Patients who received 90Y resin microsphere radioembolization for metastatic colorectal cancer with liver metastases between November 2010 and March 2011 in the USA. Patients must have at least 12 weeks of follow up.
Who cannot join
- Patients who received glass 90Y microsphere radioembolization for metastatic colorectal liver metastases.
Trial locations and contacts
1 site in 1 country.
About this study
Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up.
Read the detailed description
Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up. Objectives:
Independent data collection and reporting of pre treatment and 12 week post treatment clinical, radiographic and radiation parameters and outcomes in patients treated in the USA from 2002-2010. Data beyond 12 weeks will be collected and highly desirable, however as a minimum all patients will have 12 week follow up.
- Conditions
- Colorectal Cancer, Liver Metastases
- Keywords
- metastatic colorectal cancer, liver metastases, 90Y resin microsphere radioembolization, retrospective data analysis
- 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 |
|---|---|---|
| Control Group | Retrospective review of clinical data on at least 1,000 evaluable US patients with 12+weeks follow up that were treated with 90Y resin microsphere radioembolization for metastatic colorectal liver metastases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria.
Multiple systems monitored for side effects possibly related to liver radiotherapy.
Measured: 3 months
Secondary outcomes (1)
Radiographic response rate at 90 days (+/- 45 days) from treatment day, compared to pretreatment scans.
Pretreatment planning scans (-45 to -1 day) compared to post radiotherapy scans of the liver, PET/CT not recommended, prefer MRI with Gd or CT with contrast, 3 phase, with rescanning in similar fashion at day 90 post treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2013 (estimated)
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Kennedy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sirtex Medical
- Responsible party
- Sponsor-investigator, Andrew Kennedy, Sarah Cannon
- Investigators
- Andrew S Kennedy, MD, FACRO, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815879
- Sponsor's protocol ID
- MORE
- Acronym
- MORE
- Status last verified
- Mar 2013
- First submitted
- 18 Dec 2012
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metastatic Colorectal Cancer Liver Metastases Outcomes After Resin 90Y Microsphere Radioembolization in the USA Evaluation Project
- ClinicalTrials.gov ID
- NCT01815879
- Acronym / sponsor ID
- MORE / MORE
- Conditions
- Colorectal Cancer, Liver Metastases
- Keywords
- metastatic colorectal cancer, liver metastases, 90Y resin microsphere radioembolization, retrospective data analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Andrew KennedyIndustry (pharma, biotech, devices)
- Collaborators
- Sirtex Medical
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (estimated)
- First posted
- 21 Mar 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.
Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up.
Detailed description
Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up. Objectives:
Independent data collection and reporting of pre treatment and 12 week post treatment clinical, radiographic and radiation parameters and outcomes in patients treated in the USA from 2002-2010. Data beyond 12 weeks will be collected and highly desirable, however as a minimum all patients will have 12 week follow up.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Retrospective review of clinical data on at least 1,000 evaluable US patients with 12+weeks follow up that were treated with 90Y resin microsphere radioembolization for metastatic colorectal liver metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal liver metastases in the USA treated with 90Y resin microsphere radioembolization
Key inclusion criteria (1 listed)
- Patients who received 90Y resin microsphere radioembolization for metastatic colorectal cancer with liver metastases between November 2010 and March 2011 in the USA. Patients must have at least 12 weeks of follow up.
Key exclusion criteria (1 listed)
- Patients who received glass 90Y microsphere radioembolization for metastatic colorectal liver metastases.
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
Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria.
Time frame: 3 months
Multiple systems monitored for side effects possibly related to liver radiotherapy.
1 secondary outcome
Radiographic response rate at 90 days (+/- 45 days) from treatment day, compared to pretreatment scans.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
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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.
Andrew S Kennedy, MD, FACRO principal investigator
SCRI Development Innovations, LLC
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 and Liver Metastases, run by Andrew Kennedy at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 21 Mar 2013. 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 United States. 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?
Results are not available in the source record.
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?
Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria. (time frame: 3 months). 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 21 Mar 2013.