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    Summary
    EudraCT Number:2014-003833-24
    Sponsor's Protocol Code Number:AGMT_HNO_PN
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-06-28
    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 ConcernedAustria - BASG
    A.2EudraCT number2014-003833-24
    A.3Full title of the trial
    Randomized phase III study: Supplemental parenteral nutrition for patients with locally advanced inoperable tumors of the head and neck, receiving definitive radiotherapy with Cetuximab or Cisplatin
    Randomisierte Phase III Studie: Ergänzende parenterale Ernährung bei Patienten mit lokal fortgeschrittenen, inoperablen Kopf-Hals Tumoren, die definitiv eine Radiotherapie mit Cetuximab oder Cisplatin erhalten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized phase III study: Supplemental parenteral (applied through veins) nutrition for patients with locally advanced inoperable tumors of the head and neck, receiving definitive radiotherapy with Cetuximab or Cisplatin
    Randomisierte Phase III Studie: Ergänzende parenterale (durch Venen zugeführte) Ernährung bei Patienten mit lokal fortgeschrittenen, inoperablen Kopf-Hals Tumoren, die definitiv eine Radiotherapie mit Cetuximab oder Cisplatin erhalten
    A.3.2Name or abbreviated title of the trial where available
    AGMT_HNO_PN
    A.4.1Sponsor's protocol code numberAGMT_HNO_PN
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02236936
    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 SponsorAGMT – Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
    B.1.3.4CountryAustria
    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 supportBaxter Healthcare GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAGMT – Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
    B.5.2Functional name of contact pointDr. Judith Schuster
    B.5.3 Address:
    B.5.3.1Street AddressWolfsgartenweg 31
    B.5.3.2Town/ citySalzburg
    B.5.3.3Post code5020
    B.5.3.4CountryAustria
    B.5.4Telephone number+436649688870
    B.5.5Fax number+436626404414
    B.5.6E-mailj.schuster@agmt.at
    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 ZentroOLIMEL 5,7% mit Elektrolyten
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare GmbH, A-1020 Wien
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Emulsion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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: 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 Yes
    D.2.1.1.1Trade name Cernevit
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare, Wien
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Powder for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    D.2.1.1.1Trade name Nutryelt
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire Aguettant, Frankreich
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.11 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 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.3.4Pharmaceutical 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/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) 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 No
    D.IMP: 5
    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.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.9.2Current sponsor codeAGMT_HNO_PN
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    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: 6
    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 Addel-Trace
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire Aguettant, Frankreich
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.11 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
    Locally advanced inoperable tumors of the head and neck under definitive radiotherapy with Cetuximab or Cisplatin
    Lokal fortgeschrittene, inoperable Kopf-Hals-Tumore unter definitiver Radiotherapie mit Cetuximab oder Cisplatin
    E.1.1.1Medical condition in easily understood language
    Head and neck tumors which are locally advanced and inoperable and patients are defenitely receiving radiotherapy combined with antibody or chemotherapy
    Kopf-Hals-Tumore, welche lokal fortgeschrichten und nicht operierbar sind und die Patienten sicher eine Bestrahlungstherapie mit Antikörper oder Chemotherapie erhalten.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10031117
    E.1.2Term Oropharyngeal squamous cell carcinoma stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10041862
    E.1.2Term Squamous cell carcinoma of the oral cavity stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10041863
    E.1.2Term Squamous cell carcinoma of the oral cavity stage IV
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10031103
    E.1.2Term Oropharyngeal cancer stage unspecified
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10041855
    E.1.2Term Squamous cell carcinoma of the hypopharynx stage IV
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023860
    E.1.2Term Laryngeal squamous cell carcinoma stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10041854
    E.1.2Term Squamous cell carcinoma of the hypopharynx stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023861
    E.1.2Term Laryngeal squamous cell carcinoma stage IV
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Loss of body weight by more than 5% at the end of radiotherapy, compared with weight at the beginning of therapy, will be scored as an event of critical weight loss
    Gewichtsverlust von mehr als 5% am Ende der Radiotherapie im Vergleich zum Gewicht beim Start der Therapie wird als kritischer Gewichtsverlust gewertet.
    E.2.2Secondary objectives of the trial
    Bioelectrical Impedance Analysis (BIA): reduction of phase angle by > 10% during treatment/observation
    PEG tubes during treatment
    Toxicity during radiotherapy and chronic toxicity one year after start of treatment
    Dose and dose intensity of radiotherapy
    Assessment of physical strength via handgrip strength
    Progression-free survival (PFS) and overall survival (OS)
    Bioelektische Impedanzanalyse (BIA): Phasenwinkelreduktion um > 10% während Behandlung/Beobachtung
    Verwendung von PEG-Sonden während der Therapie
    Toxizitäten während der Strahlentherapie und chronische Toxizitäten ein Jahr nach Start der Therapie
    Dosis and Dosisintensität der Strahlentherapie
    Feststellung der physikalischen Stärke mittels Handgriffstärke
    Progression-freies Überleben (PFS) und allgemeines Überleben (OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -) Any patient who is eligible for definitive curative radio-chemotherapy with Cisplatin or radio-immunotherapy with Cetuximab.
    -) Written informed consent obtained prior to any study specific screening activities and patients have to be able to comply with this protocol.
    -) Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris treated with definitive radiotherapy in combination with Cisplatin or Cetuximab.
    -) p16 status available
    -) Age ≥ 18
    -) Women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception.
    -) Jeglicher Patient, der für eine definitive, kurative Radio-Chemotherapie mit Cisplatin oder Radio-Immuntherapie mit Cetuximab in Frage kommt
    -) Schritliche Einverständniserklärung vor jeglichen studienspezifischen Screening-Aktivitäten und die Patienten müssen dem Protokoll folgen können.
    -) Histologisch bestätigtes, lokal fortegschrittenes Plattenepithelkarzinom des Larynx, Hypopharynx, Oropharynx oder der Mundhöhle, das definitv mit Radiotherapy in Kombination mit Cisplatin oder Cetuximab behandelt wird
    -) Verfügbarer p16 Status
    -) Alter ≥ 18
    -) Gebährfähige Frauen müssen beim Screening einen negativen Schwangerschaftstest haben und eine effektive Verhütungsmethode anwenden
    E.4Principal exclusion criteria
    -) Distant metastases
    -) Prior radiation (Head and neck area)
    -) Pregnant or lactating women
    -) History of other malignancy; yet patients who have been disease-free for 5 years or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
    -) Concurrent other cancer therapy (chemotherapy, immunotherapy, antihormonal or biologic therapy) or concurrent treatment with an investigational drug.
    -) Serious medical or psychiatric disorders that would interfere with the patient’s safety or informed consent.
    -) Participation in another interventional clinical study at time of study inclusion (except follow-up period without treatment for more than 30 days) or denial of the simultaneous participation in a non-interventional study by the PI of the study center.
    -) Fernmetastasen
    -) Vorhergegangene Bestrahlung (Kopf-Hals Region)
    -) Schwangere oder stillende Frauen
    -) Andere Krebserkrankungen in der Vorgeschichte; Patienten, welche für 5 Jahre krankheitsfrei sind oder Patienten mit komplett resezierten Nicht-Melanom Hautkrebs oder erfolgreich behandelten in-situ Karzinomen sind geeignet
    -) Gleichzeitige andere Krebstherapie (Chemotherapie, Immuntherapie, antihormonelle oder biologische Therapie) oder gleichzeitige Behandlung mit anderen Prüfpräparaten
    -) Schwerwiegende medizinische oder psychiatrische Störungen, die mit der Patientensicherheit oder dem Einverständnisprozesses interferieren können.
    -) Teilnahme an einer anderen interventionellen klinischen Studie zur Zeit des Einschlusses (außer es besteht eine behandlungsfreie Periode von mehr als 30 Tagen) oder die Ablehnung einer gleichzeitigen Teilnahme an einer nicht-interventionellen Studie durch den PI oder das Studienzentrum.
    E.5 End points
    E.5.1Primary end point(s)
    Loss of body weight by more than 5% at the end of radiotherapy, compared with weight at the beginning of therapy, will be scored as an event of critical weight loss
    Gewichtsverlust von mehr als 5% am Ende der Radiotherapie im Vergleich zum Gewicht beim Start der Therapie wird als kritischer Gewichtsverlust gewertet.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Prior to radiotherapy, during and within 7 days after end of therapy
    Vor, während und innerhalb von 7 Tagen nach Ende der Strahlentherapie
    E.5.2Secondary end point(s)
    1) Bioelectrical Impedance Analysis (BIA): reduction of phase angle by > 10% during treatment/observation
    2) PEG tubes during treatment
    3) Toxicity during radiotherapy and chronic toxicity one year after start of treatment
    4) Dose and dose intensity of radiotherapy
    5) Assessment of physical strength via handgrip strength
    6) Progression-free survival (PFS) and overall survival (OS)
    1) Bioelektische Impedanzanalyse (BIA): Phasenwinkelreduktion um > 10% während Behandlung/Beobachtung
    2) Verwendung von PEG-Sonden während der Therapie
    3) Toxizitäten während der Strahlentherapie und chronische Toxizitäten ein Jahr nach Start der Therapie
    4) Dosis and Dosisintensität der Strahlentherapie
    5) Feststellung der physikalischen Stärke mittels Handgriffstärke
    6) Progression-freies Überleben (PFS) und allgemeines Überleben (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Prior to start of radiotherapy: 1, 9
    During radiotherapy: 2
    Within 7 days after end of radiotherapy: 1, 2, 3, 4, 5
    3 months after end of radiotherapy: 1, 3, 5, 6
    (Numbers see E.5.2)
    Vor Beginn der Strahlentherapie: 1, 9
    Während Strahlentherapie: 2
    Innerhalb 7 Tagen nach Ende der Strahlentherapie: 1, 2, 3, 4, 5
    3 Monate nach Ende der Strahlentherapie: 1, 3, 5, 6
    (Nummern siehe E.5.2)
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standardversorgung mit oder ohne parenteraler Ernährung
    Standard of care with or without parenteral nutrition
    E.8.2.4Number of treatment arms in the trial2
    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 concerned7
    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 (52 weeks after randomization of last patient)
    Letzte Visite des letzen Patienten (52 Wochen nach Randomisierung des letzten Patienten)
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state154
    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)
    None
    Keine
    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 Decision2016-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-07-10
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