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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2007-004603-35
    Sponsor's Protocol Code Number:REACH
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-01-14
    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 ConcernedGermany - PEI
    A.2EudraCT number2007-004603-35
    A.3Full title of the trial
    Radiotherapy (IMRT), Erbitux And Chemotherapy For Unresectable Carcinomas Of Head and Neck.
    REACH-Study
    A.3.2Name or abbreviated title of the trial where available
    REACH
    A.4.1Sponsor's protocol code numberREACH
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number87356938
    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 Heidelberg
    B.1.3.4CountryGermany
    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, Germany
    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 nameErbitux
    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.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) Yes
    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 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
    Histologically confirmed locally advanced (stage III or IV), non-metastatic squamous cell carcinoma of oro-, hypopharynx or larynx (T2-4, NX, M0).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10041849
    E.1.2Term Squamous cell carcinoma of the hypopharynx
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10023856
    E.1.2Term Laryngeal squamous cell carcinoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031112
    E.1.2Term Oropharyngeal squamous cell carcinoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the therapeutic efficacy of a combination of radiochemotherapy (IMRT + 5-fluorouracil and carboplatin) and cetuximab on the basis of Local-Regional Control (LRC).
    E.2.2Secondary objectives of the trial
    To investigate the therapeutic efficacy and safety of a combination of radiochemotherapy (IMRT + 5-fluorouracil and carboplatin) and cetuximab on the basis of:
    -Disease-free Survival,
    -Progression-free Survival,
    -Overall Survival,
    -Acute Radiation Effects,
    -Late Radiation Effects,
    -Adverse Events,
    -Proteomics and Genomics.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent,
    2. Age of 18 to 70 years,
    3. Life expectancy of at least 6 month,
    4. Ability of subject to understand character and individual consequences of clinical trial,
    5. Histologically confirmed locally advanced (stage III or IV), non-metastatic squamous cell carcinoma of the oro-, hypopharynx or larynx (T2-4, NX,M0),
    6. Oral cavity or oro- or hypopharynx as the primary tumor site,
    7. At least one uni-measurable lesion according to the RECIST criteria,
    8. Karnofsky Performances Status > 70%,
    9. Adequate bone marrow function: neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 10.0 g/dL,
    10. Adequate liver function: Bilirubin < 2.0 g/dL, SGOT, SGPT, AP, G-GT < 3 x ULN,
    11. Adequate renal function: serum creatinine < 1.5 mg/dL,
    12. Negative serum/urine Beta-HCG test in women of childbearing potential,
    13. Women of childbearing potential: willingness to use effective contraceptive method,
    14. Men of procreative potential: willingness for effective prevention of procreation,
    15. Subject’s consent to collect blood samples for proteomics and genomics analysis. (If a patient does not consent, no blood samples for proteomics and genomics will be taken).
    E.4Principal exclusion criteria
    1. Previous chemotherapy, radiotherapy or surgery for carcinoma of the head and neck,
    2. Nasopharyngeal Carcinoma,
    3. Prior exposure to EGFR pathway targeting therapy,
    4. Other serious illness or medical conditions:
    Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4,
    Significant neurologic or psychiatric disorders including dementia or seizures,
    Active disseminated intravascular coagulation,
    Other serious underlying medical conditions which in the opinion of investigator could impair the ability of the patient to participate in the study,
    Symptomatic peripheral neuropathy Common Toxicity Criteria (CTC) grade 2 or higher,
    Ototoxicity CTC grade 2 or higher, except if due to trauma or mechanical impairment due to tumor mass,
    5. Participation in other interventional trial within the last 30 days§§,
    6. Surgery within the last 30 days,
    7. Known allergic/hypersensitivity reaction to any drugs scheduled for the study treatment,
    8. Women: pregnant or breast-feeding,
    9. Known drug abuse,
    10. Other previous malignancy within 5 years, with exception of a history of a previous, adequately treated, basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix,
    11. Legal incapacity or limited legal capacity,
    12. Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    Local Regional Control:
    The time to event for local regional control will be calculated with a Cox proportional hazard model. The two-year event rate will be derived from the intercept estimate of the model, along with a 95 per cent confidence interval.
    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 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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned2
    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
    For each individual subject, the trial will consist of three phases, i.e. screening, treatment and follow-up phase:
    Screening: within four weeks prior to the first administration of IMP
    Treatment: 45 day of administration of chemoradiotherapy and cetuximab (according to the schedule given in the study protocol)
    Follow-up: 60 months after first administration of IMP (individual trial duration between 36 and 60 months).
    The clinical phase ends with the last visit in the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-01-14. Yes
    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 state60
    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)
    Study subjects will receive one study specific treatment, i.e. combination of cetuximab and radiochemotherapy. The study specific treatment will last for 45 consecutive days according to the schedule given in the study protocol. Thereafter, each subject will be given the best medically established therapy, if required (i.e. in case of disease progression).
    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 Decision2009-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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