Colorectal AdenocarcinomaPhase 2NCT00168155
Study of 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
A Phase 2 study testing perioperative chemotherapy in people with Colorectal Adenocarcinoma and Liver Metastases, run by Alberta Health services at 1 site in Canada.
Trial summary
When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma, Liver Metastases
- What is being tested?
- perioperative chemotherapy
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2002to May 2009
- Phase
- Phase 2
- 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
Who may be able to join
- stage IV colorectal cancer isolated to the liver
- one measurable lesion
- metastases are completely resectable or amenable to ablation
- Karnofsky >70
- Adequate bone marrow function
- adequate hepatic function
- adequate renal function
- informed consent
Who cannot join
- primary tumor not controlled by locoregional treatments
- bilateral portal vein and/or hepatic artery involvement
- previous chemotherapy directed at treatment of metastatic colorectal cancer
- underlying acute or chronic liver disease
- Gilbert's disease
- patients receiving phenytoin or phenobarbital prophylaxis
Show all 10Show fewer
- presence of any concurrent medical or psychiatric condition that serves as a contraindication to surgery or chemotherapy
- pregnancy
- malignancy other than basal cell or squamous cell carcinoma of the skin within the preceding 5 years
- use of another investigational medication concurrently or within 4 months of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Neoadjuvant 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.
Read the detailed description
When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.
- Conditions
- Colorectal Adenocarcinoma, Liver Metastases
- Being tested
- perioperative chemotherapy
- Keywords
- resectable liver metastases, colorectal adenocarcinoma, survival, neoadjuvant chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perioperative chemotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenocarcinomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Oliver Bathe, MD, Principal investigator, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168155
- Sponsor's protocol ID
- CPTAIV-0020-357
- Status last verified
- Sep 2011
- First submitted
- 13 Sep 2005
- Last updated
- 19 Jan 2012
- Results posted
- No
Publications
Bathe OF, Ernst S, Sutherland FR, Dixon E, Butts C, Bigam D, Holland D, Porter GA, Koppel J, Dowden S. A phase II experience with neoadjuvant irinotecan (CPT-11), 5-fluorouracil (5-FU) and leucovorin (LV) for colorectal liver metastases. BMC Cancer. 2009 May 20;9:156. doi: 10.1186/1471-2407-9-156.
PubMed 19457245
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Neoadjuvant 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00168155
- Acronym / sponsor ID
- CPTAIV-0020-357
- Conditions
- Colorectal Adenocarcinoma, Liver Metastases
- Keywords
- resectable liver metastases, colorectal adenocarcinoma, survival, neoadjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2002
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 Sep 2005 (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.
When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.
Detailed description
When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- stage IV colorectal cancer isolated to the liver
- one measurable lesion
- metastases are completely resectable or amenable to ablation
- Karnofsky >70
- Adequate bone marrow function
Key exclusion criteria (10 listed)
- primary tumor not controlled by locoregional treatments
- bilateral portal vein and/or hepatic artery involvement
- previous chemotherapy directed at treatment of metastatic colorectal cancer
- underlying acute or chronic liver disease
- Gilbert's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perioperative chemotherapy | Drug | – |
Primary outcome
disease free survival
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 19 Jan 2012.
- Derived from this study: PubMed 19457245Bathe OF, Ernst S, Sutherland FR, Dixon E, Butts C, Bigam D, Holland D, Porter GA, Koppel J, Dowden S. A phase II experience with neoadjuvant irinotecan (CPT-11), 5-fluorouracil (5-FU) and leucovorin (LV) for colorectal liver metastases. BMC Cancer. 2009 May 20;9:156. doi: 10.1186/1471-2407-9-156.
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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.
Oliver Bathe, MD principal investigator
Alberta Health services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing perioperative chemotherapy in people with Colorectal Adenocarcinoma and Liver Metastases, run by Alberta Health services at 1 site in Canada.
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 8 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 19 Jan 2012. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
disease free survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00168155, which also lists 1 linked publication.
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 19 Jan 2012; AzTrials last refreshed its copy on 7 Nov 2026.