Advanced Colorectal CancerPhase 2NCT00286000
High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study
A Phase 2 study testing Administration of high dose simplified folfiri in people with Advanced Colorectal Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- Administration of high dose simplified folfiri
- How many people
- 106 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2004to Dec 2005
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven adenocarcinoma of the colon or rectum
- Documented progressive metastatic disease
- Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to response evaluation criteria in solid tumours (RECIST)
- WHO performance status of 0 or 1
- Adequate laboratory values of haematology, liverfunction and renal function
- No previous chemotherapy for metastatic colorectal cancer
Who cannot join
- Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated cancer free of disease for more than 10 years.
- Bowel obstruction or sub-obstruction. Crohn's disease, or ulcerative colitis.
- Other severe illness or medical condition such as unstable cardiac disease under treatment, myocardial infarction within 6 months before inclusion.
- Active uncontrolled infection
- Other concomitant anticancer agent
Trial locations and contacts
1 site in 1 country.
About this study
A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer
- Conditions
- Advanced Colorectal Cancer
- Being tested
- Administration of high dose simplified folfiri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of high dose simplified folfiriDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Secondary outcomes (3)
Resectability
Safety
TTP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startJun 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Marc Peeters, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286000
- Sponsor's protocol ID
- 2004/195
- Status last verified
- Dec 2007
- First submitted
- 1 Feb 2006
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study
- ClinicalTrials.gov ID
- NCT00286000
- Acronym / sponsor ID
- 2004/195
- Conditions
- Advanced Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- Dec 2005 (actual)
- First posted
- 2 Feb 2006 (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.
A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically proven adenocarcinoma of the colon or rectum
- Documented progressive metastatic disease
- Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to response evaluation criteria in solid tumours (RECIST)
- WHO performance status of 0 or 1
- Adequate laboratory values of haematology, liverfunction and renal function
Key exclusion criteria (5 listed)
- Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated cancer free of disease for more than 10 years.
- Bowel obstruction or sub-obstruction. Crohn's disease, or ulcerative colitis.
- Other severe illness or medical condition such as unstable cardiac disease under treatment, myocardial infarction within 6 months before inclusion.
- Active uncontrolled infection
- Other concomitant anticancer agent
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 |
|---|---|---|
| Administration of high dose simplified folfiri | Drug | – |
Primary outcome
Response rate
3 secondary outcomes
Resectability
Safety
TTP
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 28 Dec 2007.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Marc Peeters, MD, PhD principal investigator
University Hospital, Ghent
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 Administration of high dose simplified folfiri in people with Advanced Colorectal Cancer, run by University Hospital, Ghent at 1 site in Belgium.
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 5 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 28 Dec 2007. 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 Belgium. 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?
Response rate. 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 28 Dec 2007.