Colorectal CancerCORIOLANNCT01591590
Correlating the Tumoral Metabolic Progression Index to Patient's Outcome in Advanced Colorectal Cancer
A study testing FDG PET-CT, Diffusion MRI and Blood samples (plasma preparation and CTC) in people with Colorectal Cancer, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
The purpose of this study is to assess whether in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FDG PET-CT, Diffusion MRI and Blood samples (plasma preparation and CTC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2012to 25 Sep 2021
- Phase
- Interventional
- 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
- Participants must have histologically confirmed colorectal cancer that is metastatic or unresectable and for which standard treatments do not exist or are no longer effective.
- The tumor should be refractory to all standard chemotherapy agents (fluoropyrimidines, irinotecan, and oxaliplatin) and anti-EGFR monoclonal antibodies in case of wild type Kras (cetuximab or panitumumab) administered before study entry. Prior treatment with bevacizumab, regorafenib and/or aflibercept is allowed but not mandatory
- Participants should be candidate for a Phase I study
- Age equal or over 18 years.
- Life expectancy of greater than 12 weeks.
- ECOG performance status ≤ 1.
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- Participants must have normal organ and marrow function as defined below:
- Total bilirubin within 2 × normal institutional upper limits AST/ALT/Alk Phosphatase levels < 5 × normal institutional upper limits Creatinine within 2 × normal institutional upper limits or creatinine clearance > 35mL/min
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry during the assessment. For women of childbearing potential a pregnancy test (urinary or serum) must be performed within 7 days prior to inclusion and it must be negative. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately within one month.
- Signed written informed consent obtained prior to any study specific screening procedures).
Who cannot join
- Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:
- Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
- Participants who have had a major surgery or radiotherapy within 4 weeks prior to entering the study.
- Patients receiving any experimental agents during the assessment time period.
- Patients with uncontrolled brain metastases.
- Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
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- Participants who have had a major surgery or radiotherapy within 4 weeks prior to entering the study
- Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or any significant disease which, in the investigator's opinion, would exclude the patient from the study.
- Pregnancy or breastfeeding before the FDG PET-CT scan examinations
- Uncontrolled Diabetes.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
- Contra-indications to the use of MRI: cardiac stimulator, implanted cardiac wires, any implanted electronic devices, intra-ocular metallic foreign bodies.
- Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlating the Tumoral Metabolic Progression Index Measured by Serial FDG PET-CT and Apparent Diffusion Coefficient Measured by MRI to Patient's Outcome in Advanced Colorectal Cancer
The purpose of this study is to assess whether in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.
Read the detailed description
Natural history of tumors is a poorly studied subject, the clinical evidence of some tumors aggressiveness as opposed to some other's indolent behavior has never been formally assessed in daily practice or in clinical studies and remains largely unpredictable. The patient's populations are in fact a mix between different tumoral phenotypes that while carrying the same apparent disease evolve with different outcomes.
We hypothesize that,in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.
If the hypothesis is verified, this finding could:
- Allow to define therapeutic strategies according to the tumoral metabolic progression index.
- Limit the need for randomization in the early drug development phases as each patient could be considered as his own control.
- To stratify patients according to their baseline metabolic growth rate in randomized controlled trials with overall survival as an endpoint.
- Conditions
- Colorectal Cancer
- Being tested
- FDG PET-CT, Diffusion MRI, Blood samples (plasma preparation and CTC)
- Keywords
- Colorectal Cancer, Cancer, Colon Cancer, Rectal Cancer, PET, PET-CT, MRI, Diffusion MRI, Apparent Diffusion Coefficient, ADC, Metabolic Progression Index
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PET-CTOther
Also called Metabolic Investigation
All patients will undergo FDG PET-CT at inclusion and 2 weeks after
Diffusion MRIOther
Also called Metabolic Investigation
All patients will undergo Diffusion MRI at inclusion and 2 weeks later
Blood samples (plasma preparation and CTC)Other
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Experimental | This is an Interventional, Non Therapeutic arm Receives: Other: FDG PET-CT; Other: Diffusion MRI; Other: Blood samples (plasma preparation and CTC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 12 months
Secondary outcomes (1)
Tumour Progression
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2019
- Study completion25 Sep 2021
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amélie Deleporte, MD, Principal investigator, Jules Bordet Institute , Universite Libre De Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591590
- Sponsor's protocol ID
- CORIOLAN
- Other IDs
- 2011-006280-21
- Acronym
- CORIOLAN
- Status last verified
- Nov 2018
- First submitted
- 2 May 2012
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Deleporte A, Paesmans M, Garcia C, Vandeputte C, Lemort M, Engelholm JL, Hoerner F, Aftimos P, Awada A, Charette N, Machiels G, Piccart M, Flamen P, Hendlisz A. Correlating tumor metabolic progression index measured by serial FDG PET-CT, apparent diffusion coefficient measured by magnetic resonance imaging (MRI) and blood genomics to patient's outcome in advanced colorectal cancer: the CORIOLAN study. BMC Cancer. 2014 May 30;14:385. doi: 10.1186/1471-2407-14-385.
PubMed 24885112
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlating the Tumoral Metabolic Progression Index Measured by Serial FDG PET-CT and Apparent Diffusion Coefficient Measured by MRI to Patient's Outcome in Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01591590
- Acronym / sponsor ID
- CORIOLAN / CORIOLAN
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Cancer, Colon Cancer, Rectal Cancer, PET, PET-CT, MRI, Diffusion MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2019 (actual)
- Study completion
- 25 Sep 2021 (actual)
- First posted
- 4 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.
The purpose of this study is to assess whether in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.
Detailed description
Natural history of tumors is a poorly studied subject, the clinical evidence of some tumors aggressiveness as opposed to some other's indolent behavior has never been formally assessed in daily practice or in clinical studies and remains largely unpredictable. The patient's populations are in fact a mix between different tumoral phenotypes that while carrying the same apparent disease evolve with different outcomes.
We hypothesize that,in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.
If the hypothesis is verified, this finding could:
- Allow to define therapeutic strategies according to the tumoral metabolic progression index.
- Limit the need for randomization in the early drug development phases as each patient could be considered as his own control.
- To stratify patients according to their baseline metabolic growth rate in randomized controlled trials with overall survival as an endpoint.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Experimental | Other: FDG PET-CT, Other: Diffusion MRI, Other: Blood samples (plasma preparation and CTC)This is an Interventional, Non Therapeutic arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must have histologically confirmed colorectal cancer that is metastatic or unresectable and for which standard treatments do not exist or are no longer effective.
- The tumor should be refractory to all standard chemotherapy agents (fluoropyrimidines, irinotecan, and oxaliplatin) and anti-EGFR monoclonal antibodies in case of wild type Kras (cetuximab or panitumumab) administered before study entry. Prior treatment with bevacizumab, regorafenib and/or aflibercept is allowed but not mandatory
- Participants should be candidate for a Phase I study
- Age equal or over 18 years.
- Life expectancy of greater than 12 weeks.
Key exclusion criteria (13 listed)
- Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:
- Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
- Participants who have had a major surgery or radiotherapy within 4 weeks prior to entering the study.
- Patients receiving any experimental agents during the assessment time period.
- Patients with uncontrolled brain metastases.
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 |
|---|---|---|
| FDG PET-CTAlso: Metabolic InvestigationAll patients will undergo FDG PET-CT at inclusion and 2 weeks after | Other | All Patients |
| Diffusion MRIAlso: Metabolic InvestigationAll patients will undergo Diffusion MRI at inclusion and 2 weeks later | Other | All Patients |
| Blood samples (plasma preparation and CTC) | Other | All Patients |
Primary outcome
Mortality
Time frame: 12 months
1 secondary outcome
Tumour Progression
Time frame: 6 months
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 26 Oct 2021.
- Derived from this study: PubMed 24885112Deleporte A, Paesmans M, Garcia C, Vandeputte C, Lemort M, Engelholm JL, Hoerner F, Aftimos P, Awada A, Charette N, Machiels G, Piccart M, Flamen P, Hendlisz A. Correlating tumor metabolic progression index measured by serial FDG PET-CT, apparent diffusion coefficient measured by magnetic resonance imaging (MRI) and blood genomics to patient's outcome in advanced colorectal cancer: the CORIOLAN study. BMC Cancer. 2014 May 30;14:385. doi: 10.1186/1471-2407-14-385.
- Jules Bordet InstituteLink 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.
Amélie Deleporte, MD principal investigator
Jules Bordet Institute , Universite Libre De Bruxelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG PET-CT, Diffusion MRI and Blood samples (plasma preparation and CTC) in people with Colorectal Cancer, run by Jules Bordet Institute 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 10 inclusion and 13 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 26 Oct 2021. 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.
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?
Mortality (time frame: 12 months). 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 NCT01591590, 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 26 Oct 2021.