Metastatic Colorectal CancerNCT00828620
Positron Emission Tomography - Computed Tomography (PET-CT) Cetuximab Project
An observational study of Metastatic Colorectal Cancer, run by Universitaire Ziekenhuizen KU Leuven at 6 sites in Belgium.
Trial summary
Molecular imaging with positron emission tomography (PET) using [18F] fluorodeoxyglucose (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Imaging study
- Type of treatment
- Injection or infusion
- How many people
- 21 participants
- Where
- 6 sitesBelgium
- Study dates
- Jan 2009to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: unresectable stage IV colorectal cancer pathologically proven measurable disease (RECIST) K-RAS wild type Eligible for 3rd line Irinotecan + Cetuximab Able for tolerate PET/CT imaging Serum glucose < 200mg/dl
Who may be able to join
- Histologically or cytologically proven colorectal cancer
- Unresectable stage IV disease
- K-Ras wild type tumour
- Patients scheduled to undergo chemotherapy with irinotecan and cetuximab
Who cannot join
- Prior abdominal/pelvic radiotherapy, surgery or chemotherapy within 3 months prior to inclusion in the study
- Poorly controlled diabetes
- Concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled hypertension, infection
- Symptomatic brain metastases
- Pregnancy or participants of reproductive potential who are sexually active and not willing/able to use medically appropriate contraception
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites
ZNA Middelheim
Antwerp
AZ Groeninge
Kortrijk
UZLeuven
Leuven, 3000
H Hart Roeselare Campus menen
Menen
Stedelijk Ziekenhuis Roeselare
Roeselare
Sint Augustinus Ziekenhuis
Wilrijk
About this study
Official title: Imaging for Early Response Prediction to EGF-receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer
Molecular imaging with positron emission tomography (PET) using [18F] fluorodeoxyglucose (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be highly sensitive in detecting early response in other tumours. In this study, the investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6) in outcome prediction.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Imaging study
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging studyOther
PET-CT
| Study group | Role | What they receive |
|---|---|---|
| PET-CT | Patients with Unresectable stage IV colorectal cancer; eligible for 3rd line Irinotecan and Cetuximab Receives: Other: Imaging study |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET response on day 7
Measured: day 7
Secondary outcomes (5)
To determine whether the PET criteria for response on day 7 correlates with the CT criteria of minimum 10% decrease in tumour size (RECIST) at week 6
Measured: week 6
To define the optimal cutoff value of SUVmax and their predictive value
Measured: at day 7 and week 6
To explore the test/retest reliability of PET/CT in this setting
Measured: 2 weeks
To assess the value of PET/CT at day 7 in predicting overall survival
Measured: up to 1 year
To asses the correlations between biomarkers and PET changes after Cetuximab
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2011
- Study completionJun 2012
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Van Cutsem, Prof.Dr, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828620
- Sponsor's protocol ID
- s51276 - ML5241
- Status last verified
- Jun 2012
- First submitted
- 23 Jan 2009
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging for Early Response Prediction to EGF-receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00828620
- Acronym / sponsor ID
- s51276 - ML5241
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Jan 2009 (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.
Molecular imaging with positron emission tomography (PET) using [18F] fluorodeoxyglucose (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be highly sensitive in detecting early response in other tumours. In this study, the investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6) in outcome prediction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-CT | – | Other: Imaging studyPatients with Unresectable stage IV colorectal cancer; eligible for 3rd line Irinotecan and Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- unresectable stage IV colorectal cancer pathologically proven measurable disease (RECIST) K-RAS wild type Eligible for 3rd line Irinotecan + Cetuximab Able for tolerate PET/CT imaging Serum glucose < 200mg/dl
Key inclusion criteria (4 listed)
- Histologically or cytologically proven colorectal cancer
- Unresectable stage IV disease
- K-Ras wild type tumour
- Patients scheduled to undergo chemotherapy with irinotecan and cetuximab
Key exclusion criteria (5 listed)
- Prior abdominal/pelvic radiotherapy, surgery or chemotherapy within 3 months prior to inclusion in the study
- Poorly controlled diabetes
- Concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled hypertension, infection
- Symptomatic brain metastases
- Pregnancy or participants of reproductive potential who are sexually active and not willing/able to use medically appropriate contraception
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 |
|---|---|---|
| Imaging studyPET-CT | Other | PET-CT |
Primary outcome
PET response on day 7
Time frame: day 7
5 secondary outcomes
To determine whether the PET criteria for response on day 7 correlates with the CT criteria of minimum 10% decrease in tumour size (RECIST) at week 6
Time frame: week 6
To define the optimal cutoff value of SUVmax and their predictive value
Time frame: at day 7 and week 6
To explore the test/retest reliability of PET/CT in this setting
Time frame: 2 weeks
To assess the value of PET/CT at day 7 in predicting overall survival
Time frame: up to 1 year
To asses the correlations between biomarkers and PET changes after Cetuximab
Time frame: up to 6 months
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 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.
Eric Van Cutsem, Prof.Dr principal investigator
UZ Leuven
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Universitaire Ziekenhuizen KU Leuven at 6 sites 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 4 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: stopped early, as of the sponsor's last update on 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). 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?
PET response on day 7 (time frame: day 7). 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 10 Aug 2012; AzTrials last refreshed its copy on 31 Oct 2026.