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    Summary
    EudraCT Number:2016-003306-13
    Sponsor's Protocol Code Number:CCR4557
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-003306-13
    A.3Full title of the trial
    CCR 4557: Peri-operative Immuno-Chemotherapy in Operable oesophageal aNd gastrIc Cancer (ICONIC Trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Peri-operative Immuno-Chemotherapy in Operable oesophageal aNd gastrIc Cancer
    A.3.2Name or abbreviated title of the trial where available
    ICONIC
    A.4.1Sponsor's protocol code numberCCR4557
    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 SponsorThe Royal Marsden NHS Foundation Trust
    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 supportMerck Serono Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Royal Marsden NHS Foundation Trust
    B.5.2Functional name of contact pointGI & Lymphoma Clinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Medicine, The Royal Marsden NHS Foundation Trust
    B.5.3.2Town/ citySutton, Surrey
    B.5.3.3Post codeSM2 5PT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02086613279
    B.5.5Fax number02089156731
    B.5.6E-mailangela.gillbanks@rmh.nhs.uk
    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.2.1.1.1Trade name Avelumab
    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 nameAvelumab
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNAVELUMAB
    D.3.9.1CAS number 1537032-82-8
    D.3.9.2Current sponsor codeMSB0010718C
    D.3.9.3Other descriptive nameAnti-PD-L1
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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 Information not present in EudraCT
    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 nameOxaliplatin
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for infusion
    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 INNOxaliplatin
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number85
    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 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 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: 3
    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 Information not present in EudraCT
    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 nameFluorouracil
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluorouracil
    D.3.9.1CAS number 51-21-8
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2800
    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 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 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: 4
    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 Information not present in EudraCT
    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 nameFolinic acid
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for infusion
    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 INNFolinic acid
    D.3.9.1CAS number 58-05-9
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Operable oesophageal and gastric cancer
    E.1.1.1Medical condition in easily understood language
    Cancers arising from the oesophagus or the stomach that the doctor thinks can be operated on
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10062878
    E.1.2Term Gastrooesophageal cancer
    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
    There are two parts to the trial: the first is the 'safety run-in' phase and the second is the 'main phase' or 'efficacy phase'. Each of these has different principal research objectives:
    - The 'safety run-in' phase will establish the safe and tolerated dose of Avelumab in combination with FOLFOX in the first 6 to 12 patients entered into the trial. This so called 'maximum administered dose' will then be used for all subsequent patients entered into the main phase.
    -The 'main phase' will assess the efficacy of FOLFOX-A in the peri-operative setting in patients with operable GOAs. We aim to increase the pathologic complete response rate from currently <5% with standard peri-operative chemotherapy to 20% with FOLFOX in combination with Avelumab. This would be an important achievement as patients who achieve a pathologic complete response with peri-operative therapy tend to have a better prognosis and are at much lower risk for subsequent distant disease recurrence.
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of peri-operative FOLFOX-A
    • To assess further efficacy measures including:
    - pathological regression grading
    - R0 resection rate (i.e. complete removal of the cancer at the time of surgery)
    - Progression free survival
    - Overall survival
    - Radiological responses in the pre-operative phase
    • To perform translational research analysis that may identify candidate predictive biomarkers, drug resistance mechanisms and biological rationals for more effective furture therapies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    i. Histologically confirmed gastric, gastro-oesophageal junction or oesophageal adenocarcinoma (referred to as gastro-oesophageal adenocarcinoma (GOA) in this protocol).
    ii. Oesophageal and gastric tumours should be TNM7 stage T1-3 and N0-N2, with no evidence of distant metastases (M0) where the MDT believes that an R0 resection can be achieved at the outset. T4 tumours will be excluded due to the variable need to prolong pre-operative chemotherapy or chemo-radiotherapy as part of locally advanced protocol to reduce margin involvement and improve resectability.
    iii. Absence of distant metastases on CT scan and PET scan and staging laparoscopy (where indicated) prior to study entry
    iv. No prior therapy for GOA
    v. Adequate cardio-pulmonary reserve as assessed by: Supervised Incremental Shuttle Walk threshold > 350 metres, or formal CPET testing with an anaerobic threshold ≥9 mls/min/kg.
    vi. Adequate bone marrow function:
    • Absolute neutrophil count (ANC) >1.5x10-9/L
    • White blood count >3x10-9/L
    • Platelets ≥100x10-9/L
    • Haemoglobin (Hb) >9g/dl (can be post-transfusion)
    viii. Adequate renal function: glomerular filtration rate (GFR) ≥30ml/min calculated (as per local practice) or measured. If the calculated GFR is <60ml/min then a measured GFR is required. The measured GFR should always take precedence over the calculated GFR
    ix. Adequate liver function
    • Serum bilirubin ≤1.5x ULN
    • ALT/AST ≤2.5x ULN
    x. Adequate coagulation profile
    • International Normalised Ratio (INR) < 1.5
    • Activated Prothrombin Time (APTT) < 1.5xULN
    xi. Patients on oral anticoagulation are advised to change to low molecular weight heparin prior to study entry, to be eligible
    xii. ECOG performance status 0 or 1
    xiii. BMI ≤35
    xiv. Patient is fit to undergo all protocol investigations and receive all protocol treatment based on the assessment in the surgical and oncology clinics
    xv. Male/female patients aged ≥18 years
    xvi. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.
    xvii. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans
    E.4Principal exclusion criteria
    Patients are not eligible for the trial if any of the exclusion criteria below are met:
    i. Any contraindication or known hypersensitivity reaction to any of the study drugs, or components of Folinic acid, Oxaliplatin, or 5FU
    ii. Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI CTCAE v 4.0), any history of anaphylaxis, or uncontrolled asthma (i.e., 3 or more features of partially controlled asthma)
    iii. Known dihydropyrimidine dehydrogenase (DPD) deficiency
    iv. Patients who have received chemotherapy, radiotherapy or immunotherapy for a previous malignancy
    v. Any previous malignancy, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
    vi. Patients recommended to have radiotherapy as part of routine management for their GOA are ineligible
    vii. Any immunodeficiency disorder
    viii. Any active, known or suspected autoimmune disease that might deteriorate when receiving immunostimulatory agent, with the following exceptions:
    • Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
    • Patients requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤10mg (or equivalent) of prednisolone per day
    • Administration of steroids through a route known to result in minimal systemic exposure (topical, intranasal intra-ocular, or inhalation) are acceptable
    ix. Prior organ transplantation, including allogeneic stem-cell transplantation
    x. History of inflammatory bowel disease
    xi. Patients with a history of interstitial lung disease or radiological evidence of pulmonary fibrosis
    xii. Cerebrovascular disease (including transient ischaemic attacks (TIA) and strokes) within the previous year
    xiii. Cardiovascular diseases as follows:
    • Myocardial infarction within the previous year
    • Serious cardiac arrhythmia requiring medication (for example,
    ventricular tachycardia, supraventricular tachycardia or atrial fibrillation with a resting heart rate > 110bpm)
    xiv. Current signs or symptoms of any other severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, respiratory or cardiac disease other than directly related to gastro-oesophageal adenocarcinoma, which in the opinion of the investigator, might impair the subject’s tolerance of trial treatment or procedures.
    xv. Major surgery, major trauma or open biopsy within 28 days prior to registration (not including staging laparoscopy)
    xvi. Evidence of bleeding diathesis or coagulopathy
    xvii. Active non-healing wound, ulcer or bone fracture requiring therapy
    xviii. Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis A or C virus, acute or chronic active hepatitis B infection
    xix. Known peripheral neuropathy > grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)
    xx. Use of live attenuated vaccine within 28 days of initiation of study therapy, or anticipation that a live attenuated vaccine will be required during the study
    xxi. Pregnancy must be excluded with a negative serum pregnancy test, within 7 days before initiation of therapy. Female patients must be surgically sterile or be postmenopausal or must agree to use highly effective contraception. Male patients must be surgically sterile or must agree to use highly effective contraception, defined as methods with a failure rate of <1% per year
    xxii. Any patient specific factors which are likely to interfere with compliance of trial specific procedures or treatment.
    E.5 End points
    E.5.1Primary end point(s)
    Safety run-in phase: The primary endpoint for the safety run-in phase will be to establish the maximum administered dose (MAD) of Avelumab in combination with FOLFOX that will be recommended for use in the main phase of the trial.

    Main (efficacy) phase: The primary endpoint is the pathologic complete response rate (pCR rate).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety run in:
    Once 6-12 patients have been treated, each for at least 28 days. We anticipate this part to complete within 6 months.


    Main efficacy phase:
    Once 38 patients have been treated at the dose level recommended in the safety run in phase and have undergone surgery. This phase is expected to complete within 2 years
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    1) Safety of peri-operative FOLFOX-A in patients with operable gastro-oesophageal adenocarcinoma
    2) To assess further efficacy measures including:
    - Mandard pathological regression grading assessed in the resection specimen
    - Radiological response rate assessed at the pre-operative scan using RECIST 1.1 criteria, additional radiological response criteria may also be applied
    - R0 resection rate
    - PFS
    - OS
    - Heterogeneity of regression grading of the primary cancer in comparison to lymph node metastatic cancer

    E.5.2.1Timepoint(s) of evaluation of this end point
    The following endpoints will be reported after ~2 y, when 38 patients have undergone surgery:
    -Safety of peri-operative FOLFOX-A in patients with operable gastro-oesophageal adenocarcinoma
    -Mandard pathological regression grading assessed in the resection specimen
    -Radiological response rate assessed at the pre-operative scan using RECIST 1.1 criteria, additional radiological response criteria may also be applied
    -R0 resection rate
    -Heterogeneity of regression grading of the primary cancer in comparison to lymph node metastatic cancer
    Survival endpoints will be reported as 1 year and 2 year PFS/OS, approximately 3 and 4 y after study start. Kaplan Meier analysed will be performed once sufficient events have occurred and when the last patient had the last follow visit (~y 7).
    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 No
    E.6.11Pharmacogenomic No
    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) 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 No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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)
    Trial participants will only receive FOLFOX-A for a fixed period of time. At present there is no indication/known benefit to continue it beyond a fixed period of 4 cycles pre-op and, in those who are fit enough, 4 cycles post op.
    However, participants will be advised by their treating oncologist if any further treatment is necessary and what these treatments could be.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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