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    Summary
    EudraCT Number:2006-002241-37
    Sponsor's Protocol Code Number:2006/VCC/0039 (WCTU01)
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-002241-37
    A.3Full title of the trial
    A randomised phase II/III multi-centre clinical trial of definitive chemo-radiaiton, with or without cetuximab, in carcinoma of the oesophagus
    A.3.2Name or abbreviated title of the trial where available
    SCOPE 1
    A.4.1Sponsor's protocol code number2006/VCC/0039 (WCTU01)
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number47718479
    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 SponsorVelindre NHS 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 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 Yes
    D.2.1.1.1Trade name Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namecetuximab
    D.3.2Product code EMD271786
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCETUXIMAB
    D.3.9.1CAS number 205923564
    D.3.9.2Current sponsor codeEMD271786
    D.3.9.3Other descriptive namecetuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 typeMonoclonal 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
    in-operable carcinoma of the oesophagus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10030151
    E.1.2Term Oesophageal cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether the addition of cetuximab to definitive chemo-radiation (CRT) results in increased survivial, and is safe and feasible to use in the treatment of patients with non-metastatic carcinoma of the oesophagus.
    E.2.2Secondary objectives of the trial
    Toxicity
    Feasibility
    Health Economics
    Quality of Life
    Quality Assurance
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-studies in translational research are subject to a separate protocol in development.
    Radiotherapy quality assurance sub-study has a detailed protocol included with the main study protocol.
    E.3Principal inclusion criteria
    1. Older than 18 years of age.
    2. Have been selected to receive potentially curative definitive chemo-radiation by a specialist Upper GI MDT including a designated upper GI surgeon.
    3. Who are not suitable for surgery either for medical reasons or through patient choice.
    4. Histologically confirmed carcinoma of the oesophagus (adenocarcinoma, squamous cell or undifferentiated carcinoma) or Siewert Type 1 tumour of the gastro-oesophageal junction (GOJ) or Siewert Type 2 with no more than 2 cm mucosal extension into the stomach.
    5. Tumours staged with both endoscopic ultrasound (EUS) and spiral CT scan to be T1-4, N0-1 confirming localised, non-metastatic disease (both within 6 weeks prior to randomisation, but the most recent within 4 weeks).
    6. Total disease length (primary and lymph nodes) less than 10cm defined by EUS.
    7. Patients clear of previous malignancies for a period of 5 years prior to randomisation.
    8. WHO performance status 0-1.
    9. Adequate cardiovascular function for safe delivery of chemo-radiation in the opinion of the principal investigator.
    • Where there is clinical concern patients should have an adequate cardiac ejection fraction ≥ 40% as determined by MUGA scan or ECHO (within 4 weeks prior to randomisation).
    10. Adequate respiratory function for safe delivery of chemo-radiation in the opinion of the principal investigator.
    • Where there is clinical concern FEV1 ≥ 1 litre as determined by spirometry (within 4 weeks prior to randomisation).
    11. Adequate bone marrow and hepatic function (within 1 week prior to randomisation)
    • Absolute neutrophil count (ANC) ≥ 1.5x109/L
    • White blood cell count ≥ 3x109/L
    • Platelets ≥ 100x109/L
    • Haemoglobin (Hb) ≥ 10g/dL (patients Hb should be corrected to >10g/dl before treatment)
    • Adequate liver function (within 1 week prior to randomisation)
    • Serum bilirubin ≤ 1.5x ULN
    • ALT / AST ≤ 2.5x ULN
    • ALP ≤ 3x ULN
    12. Adequate renal function (within 1 week prior to randomisation)
    • Glomerular filtration rate (GFR) assessed by EDTA clearance to be > 40mL/min (or estimated by Cockcroft-Gault formula to be > 60 mL/min).
    13. Patients who are fit to receive all protocol treatment.
    14. Patients who are able and willing to administer capecitabine.
    15. Patients who are of child bearing age are willing to use contraception.
    16. Patients who have completed baseline quality of life questionnaires.
    17. Patients who have provided written informed consent prior to randomisation.
    E.4Principal exclusion criteria
    1. Patients who have had previous treatment for invasive oesophageal carcinoma or gastro-oesophageal junction carcinoma (not including PDT or laser therapy for high grade dysplasia/carcinoma in-situ).
    2. Patients with metastatic disease i.e. M1a or M1b according to UICC TNM version 6.
    3. Patients with previous treatment for malignancy which compromises the ability to deliver definitive mediastinal chemo-radiation or may compromise survival.
    4. patients who have had a previous malignancy during the previous 5 years
    5. Patients with significant (>2cm) extension of tumour into the stomach.
    6. Patients with unstable angina or uncontrolled hypertension or cardiac failure or other clinically significant cardiac disease.
    7. Patients who have had major surgery or major trauma in the 4 weeks prior to randomisation.
    8. Patients who have been treated with a monoclonal antibody in the 4 weeks prior to randomisation.
    9. Patients who have been treated with radiotherapy in the 3 months prior to randomisation.
    10. Patients who need continued treatment with a contraindicated concomitant medication or therapy.
    11. Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
    12. Patients with hearing impairment or sensory-motor neuropathy of WHO grade > 2.
    13. Women who are pregnant.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival. Overall survival is calculated from the date of randomisation, to death from any cause.
    Those still alive will be censored at the last time seen.
    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 Yes
    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) 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 Yes
    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
    routine clinical care of chemoradiotherapy
    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 concerned50
    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 trial will be considered closed to recruitment when the last patient has completed protocol treatment and the week 24 assessment which inlcudes EUS and CT scan.

    However further observational follow-up of all patients will continue for a minimum of 5 years. This will be done via the hospital but in the longer term this may be carried out via the Office of National Statistics or NHS Central Register.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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 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 state420
    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)
    As per normal clinical practice
    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 Decision2007-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-15
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