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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2007-001987-55
    Sponsor's Protocol Code Number:87163246
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-18
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2007-001987-55
    A.3Full title of the trial
    Fluoropyrimidine, Oxaliplatin & Targeted Receptor pre-Operative Therapy for colon cancer: A randomised trial assessing whether preoperative chemotherapy and/or an anti-EGFR monoclonal antibody improve outcome in high-risk operable colon cancer
    A.3.2Name or abbreviated title of the trial where available
    FOxTROT
    A.4.1Sponsor's protocol code number87163246
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN87163246
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Of Birmingham
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namePanitumumab
    D.3.2Product code AMG954
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeIg-G2 monoclonal antibody
    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
    Patients with high-risk, operable colon cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10009955
    E.1.2Term Colon cancer stage III
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10009956
    E.1.2Term Colon cancer stage IV
    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
    A high-quality, multi-centre randomised controlled trial to determine if giving the first 6 weeks of an optimum combination chemotherapy regimen prior to surgery, as opposed to 24 weeks post-surgery, can reduce the risk of recurrence in patients with high-risk operable colon cancer. The effect of the addition of the monoclonal antibody, EGFR, with demonstated results in later stage disease, will also be evaluated.

    The pilot phase of the study (150 patients recruited) will also investigate the accuracy of pre-treatment CT scan staging and assess the tolerability and feasibility of the treatments.

    The main objective of the trial is to establish:
    • Does neoadjuvant chemotherapy±panitumumab, an anti-EGFR monoclonal antibody, followed by deferred surgery and completion of chemotherapy post-operatively reduce 2-year recurrence as compared to surgery and postoperative chemotherapy±panitumumab?
    • Does adding panitumumab reduce 2-year recurrence?
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial are:
    • Is there down-staging of tumours following neoadjuvant therapy, in terms of:
    - reduced nodal involvement?
    - reduced margin involvement in the resected tumour, serosa or mesentery?
    - Improved quality of resection specimen (completeness of mesenteric envelope)?
    •What are the nature and frequency of adverse events associated with surgery following neoadjuvant therapy?
    •What impact does neoadjuvant therapy have on the quality of life of patients?
    •Are there health economic benefits for neoadjuvant chemotherapy?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. Histologically proven colon cancer with a radiological staging of greater than or equal to T3, NX, M0.
    2. Patients who have been fully staged radiologically by CT scanning and are poor prognosis (ref to protocol for further info).
    3. Fit for the neoadjuvant treatments; (details in protocol)
    4. Patients who have presented with acute colonic obstruction may enter the trial only if a successful defunctioning or stent procedure has been performed.
    5. Patients able and willing to provide written informed consent for the study.
    E.4Principal exclusion criteria
    Exclusion criteria:
    1. Patients with evidence of disseminated disease.
    2. Patients with tumour with rectal cancer
    3. Patients with peritonitis (secondary to perforated tumour)
    4. Patients with obstruction, who are not defunctioned or stented.
    5. Patients unable to give informed consent.
    6. Patients with serious medical comorbidity
    7. Patients with an indication for radiotherapy
    8. Patients under the age of 18 or pregnant.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for the comparison of pre- plus post-operative versus post-operative chemotherapy alone will be freedom from recurrence (or persistent disease) two years following randomisation. This includes failure of macroscopic disease clearance at primary surgery as well as colon cancer recurrence.

    The rationale for choosing two-year recurrence as primary outcome is to maximise statistical power as almost all of the effect of chemotherapy on recurrence is concentrated in this period. For example, in the QUASAR study adjuvant fluorouracil/ folinic acid chemotherapy reduced the risk of recurrence by 36% (99% CI 16%-51%) in the first two years following surgery with no further benefit or loss of benefit subsequently.

    The primary outcome measure for the comparison of preoperative chemotherapy with and without panitumumab will be pathological down-staging following chemotherapy as measured by depth of extramural spread.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No panitumumab
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of the trial is defined as the time when the last patient recruited has their 24-month follow-up (24 month as the primary outcome is disease free recurrence at 2 years).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1050
    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 Decision2013-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-21
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