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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   43202   clinical trials with a EudraCT protocol, of which   7150   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-001879-37
    Sponsor's Protocol Code Number:ArtscanIII
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-12-19
    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 number2012-001879-37
    A.3Full title of the trial
    A randomized multicenter phase III study of cisplatin plus radiotherapy compared to cetuximab plus radiotherapy in locally advanced head and neck cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized study of cisplatin plus radiotherapy compared to cetuximab plus radiotherapy in locally advanced head and neck cancer
    A.3.2Name or abbreviated title of the trial where available
    ARTSCANIII
    A.4.1Sponsor's protocol code numberArtscanIII
    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 SponsorDepartment of Oncology, Skåne University Hospital Lund
    B.1.3.4CountrySweden
    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 supportCancerfonden
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaria Gebre-Medhin
    B.5.2Functional name of contact pointCoordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Oncology, Skåne University Hospital Lund
    B.5.3.2Town/ cityLund
    B.5.3.3Post codeSe-211 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+464617 00 00
    B.5.6E-mailmaria.gebre-medhin@skane.se
    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 AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical 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 INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    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) 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 Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Cisplatin
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Concentrate for 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 INNCISPLATIN
    D.3.9.1CAS number 15663-27-1
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stage III and IV head and neck squamous cell cancer (HNSCC) without radiographic signs of distant metastases aimed for radiotherapy with curative intent
    E.1.1.1Medical condition in easily understood language
    Stage III and IV head and neck squamous cell cancer (HNSCC) without radiographic signs of distant metastases aimed for radiotherapy with curative intent
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10071536
    E.1.2Term Head and neck 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 14.1
    E.1.2Level PT
    E.1.2Classification code 10071537
    E.1.2Term Head and neck cancer stage III
    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 study whether overall survival is improved by treatment with radiotherapy + cetuximab compared to treatment with radio radiotherapy + cisplatin in the treatment of patients with locally advanced (stage III-IV) head and neck squamous cell carcinoma (HNSCC).
    E.2.2Secondary objectives of the trial
    •To study whether local control is enhanced with dose-escalated radiotherapy + cetuximab/cisplatin compared to treatment with standard-dose radiotherapy + cetuximab/cisplatin in locally advanced (T3 and T4) tumours
    •To describe early and late side effects of the treatment arms
    •To compare local and regional tumour control between the treatment arms
    •To determine pattern of failure
    •To evaluate quality of life
    •To determine if HPV and p16 positivity can consist a prognostic marker
    •To compare normal tissue sparing and normal tissue complications with different treatment techniques (3D-CRT vs. IMRT/VMAT/HTT) and radiotherapy only vs. radiochemotherapy by comparison with the results from the first ARTSCAN study
    •To make a health economic comparison between treatment with radiotherapy and cisplatin and treatment with radiotherapy and cetuximab
    •To find biomarkers that can guide therapy decisions
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The study has a separate translational part, with investigation of blood cells as well as tumour tissue, in order to study prognostic and predictive biomarkers. This part requires a separate informed consent.
    E.3Principal inclusion criteria
    1.The patient must be over 18 years old.
    2.Histologically or cytologically confirmed HNSCC of the oropharynx, hypopharynx, larynx or of the oral cavity aimed for unimodal treatment with radiotherapy with curative intent.
    3.Tumour stage III and IV according to the UICC TNM classification, but with no evidence of distant metastases beyond the regional nodes in the neck.
    4.WHO/ECOG performance status 0-2
    5.The patient must be expected to withstand radiotherapy combined with cisplatin or cetuximab.
    6.The patient must be able to understand the information about the treatment and give a written informed consent to participate in the trial.
    7.Adequate follow-up study must be possible; this will exclude a patient who is uncooperative.
    8.Adequate renal function, creatinine clearance > 50 mL/min/1.73 estimated according to local practise at each study centre
    E.4Principal exclusion criteria
    1.Previous malignant disease in the head and neck region, with exception for basal cell carcinoma or curatively treated squamous cell carcinoma of the skin with follow-up time of at least 3 years.

    2.Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix uteri, or other previous malignancy with a disease-free interval of at least 5 years.

    3.Two or more synchronous primary HNSCC at time of diagnosis

    4.Co-existing disease prejudicing survival (expected survival >6 months).

    5.Absolute neutrophil count (ANC) < 1.5 x 109/L.

    6. Platelet count < 100 x 109/L.

    7. Bilirubin > 1.5 times upper limit of normal (ULN)

    8. Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) >3 times ULN

    9. Pregnancy or lactation

    10. Allergy to study drug or to the excipients in their formulation.

    11. Peripheral neuropathy > grade 2 according to CTCAE v4.0, grade 2 = moderate symptoms limiting instrumental ADL)

    12. Hearing loss / tinnitus is a relative exclusion criteria;

    13. Severe cardiac illness
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Follow up by the protocol ends at five years after end of treatment
    E.5.2Secondary end point(s)
    •Differences in local control between treatment with dose-escalated radiotherapy + cetuximab/cisplatin compared to treatment with standard-dose radiotherapy + cetuximab/cisplatin in locally advanced (T3 and T4) tumours
    •Early and late side effects
    •Local and regional tumour control
    •Pattern of failure
    •Quality of life
    •Prognostic value of HPV and p16 positivity
    •Normal tissue sparing and normal tissue complications
    •Cost-utility analysis
    •Exploratory, biomarker investigations (separate informed consent required)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Five years after end of treatment
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Two different doses of radiotherapy
    E.8.2.4Number of treatment arms in the trial4
    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 concerned10
    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
    The last patients last vist
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years11
    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 years11
    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.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 218
    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 state618
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 618
    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)
    Treatment according to clinical routines
    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 Decision2013-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-05
    P. End of Trial
    P.End of Trial StatusOngoing
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