Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-006280-21
    Sponsor's Protocol Code Number:CORIOLAN
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-03
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-006280-21
    A.3Full title of the trial
    Correlating the tumoral metabolic progression index measured by serial FDG PET-CT and apparent diffusion coefficient measured by MRI to patient's outcome in advance colorectal cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The change in PET and MRI measurements over time as a predictor for metastatic colorectal cancer outcome.
    A.3.2Name or abbreviated title of the trial where available
    CORIOLAN
    A.4.1Sponsor's protocol code numberCORIOLAN
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJules Bordet Institute
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKing Baudouin Foundation
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportLes amis de l'Institut Bordet asbl
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJules Bordet Institute
    B.5.2Functional name of contact pointAmélie Deleporte
    B.5.3 Address:
    B.5.3.1Street Addressrue Heger Bordet, 1
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1000
    B.5.3.4CountryBelgium
    B.5.4Telephone number003225417209
    B.5.5Fax number003225380858
    B.5.6E-mailamelie.deleporte@bordet.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name[18F]Fluoro-2-Deoxy-D-Glucose
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN fludeoxyglucose (18F)
    D.3.9.3Other descriptive nameFDG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number185
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fludeoxyglucose (18F) – IBA
    D.2.1.1.2Name of the Marketing Authorisation holderIon Beam Application
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFludeoxyglucose (F-18)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN fludeoxyglucose (18F)
    D.3.9.3Other descriptive nameFDG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number185
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced colorectal cancer, refractory to all available medications
    E.1.1.1Medical condition in easily understood language
    Advanced colorectal cancer that do not respond to standard treatment.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10010035
    E.1.2Term Colorectal cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the spontaneous evolution of tumoral metabolic progression index measured by serial FDG PET-CT without any intercurrent antitumor therapy as a prognostic factor for overall survival in patients with advanced colorectal cancer.
    E.2.2Secondary objectives of the trial
    •Test TMPI as a prognostic marker for PFS.
    •Assess the prognostic value of baseline tumor FDG uptake on PFS and OS.
    •Compare TMPI to classical clinico-biologic assessment of prognosis (alkaline phosphatase, platelets count, LDH, tumor bulk)
    •Test the prognostic value of MRI based apparent diffusion coefficient (ADC) and variation of vADC based on voxel-based diffusion maps.
    •Translational research:
    -To identify and quantify tumor-specific rearrangements in plasma DNA using next-generation sequencing.
    -To characterize which of these tumor-specific rearrangements in plasma DNA form genomic and epigenetic determinants of tumoral metabolic progression guided by FDG-PET-CT metabolic imaging.
    -To identify these tumor-specific rearrangements in previous tumor tissue.
    -To analyze whether CTC levels correlate with tumoral metabolic progression guided by FDG PET-CT metabolic imaging.
    -To assess the prognostic value of CTCs on overall survival.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •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.
    •Participants should be candidate for a Phase I study
    •The tumor should be refractory to all standard chemotherapy agents (fluoropyrimidines, irinotecan, and oxaliplatin) and anti‐EGFR monoclonal antibodies in case of wild type K‐ras (cetuximab or panitumumab) administered before study entry. Prior treatment with bevacizumab, regorafenib and/or aflibercept is allowed but not mandatory
    •Age equal or over 18 years.
    •Life expectancy of greater than 12 weeks.
    •ECOG performance status ≤ 1.
    •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 and during the assessment. For women of child-bearing 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 within one month.
    •Signed written informed consent obtained prior to any study specific screening procedures.
    E.4Principal exclusion criteria
    Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:
    •Participants who have had chemotherapy or targeted therapy 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.
    •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 breast-feeding 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.
    •Medical, geographical, sociological, psychological or legal conditions that would not allow the patient to complete the study or sign informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the spontaneous evolution of tumoral metabolic progression index measured by serial FDG PET-CT without any intercurrent antitumor therapy as a prognostic factor for overall survival in patients with advanced colorectal cancer.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and after two weeks to be correlated with the patient overall survival.
    E.5.2Secondary end point(s)
    1. To test tumoral metabolic progression index as a prognostic marker for progression free survival.
    2. To assess the prognostic value of baseline tumor FDG uptake on progression free survival and overall survival.
    3. To compare tumoral metabolic progression index to classical clinico-biologic assessment of prognosis (alkaline phosphatase, platelets count, LDH, tumor bulk)
    4. To test the prognostic value of MRI based apparent diffusion coefficient (ADC) and variation of vADC based on voxel-based diffusion maps.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At baseline and after two weeks to be correlated with the patient progression free survival.
    2. At baseline and to be correlated with the patient progression free survival and overall survival.
    3. At baseline and after two weeks to be correlated with the patient overall survival.
    4. At baseline and after two weeks to be correlated with the patient progression free survival and overall survival.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    This is an interventional non-therapeutic study aiming to assess the spontaenous evolution of tumoral metabolic progression index measured by serial FDG PET-CT and MRI without any intercurrent antitumor therapy as a prognostic factor for overall survival in patients with advanced colorectal cancer.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Required number of evaluable patients with documented death will be 37 as required by the stat.analysis/Database is fully cleaned&frozen for the primary analysis&for the analysis of the 2nd endpoint/Number of events is not reached&a decision to stop accrual has been taken by the principal investigator/Participants will be followed for 1year or until 1of the following criteria applies/Withdrawal/Lost to follow-up/Death
    Required number of evaluable patients with documented death will be 37 as required by the stat.analysis/Database is fully cleaned&frozen for the primary analysis&for the analysis of the 2nd endpoint/Number of events is not reached&a decision to stop accrual has been taken by the principal investigator/Participants will be followed for 1year or until 1of the following criteria applies/Withdrawal/Lost to follow-up/Death
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state53
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participation to a phase I study or treatment at the Investigator discretion
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-25
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 02:07:11 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA