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    Summary
    EudraCT Number:2013-004111-42
    Sponsor's Protocol Code Number:TRAP
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-03
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-004111-42
    A.3Full title of the trial
    Feasibility study of chemoradiation, TRAstuzumab and Pertuzumab in resectable HER2+ esophageal carcinoma
    Haalbaarheidsstudie van chemoradiatie, trastuzumab en Pertuzumab in resectable HER2 + slokdarmcarcinoom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chemoradiation in combination with trastuzumab and pertuzumab in operable esophageal carcinoma
    Chemoradiatie in combinatie met trastuzumab en pertuzumab bij operabel slokdarm kanker
    A.3.2Name or abbreviated title of the trial where available
    TRAP
    TRAP
    A.4.1Sponsor's protocol code numberTRAP
    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 SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    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 supportUniversity Amsterdam
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointEva van Daalen
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31205668229
    B.5.5Fax number+31206919743
    B.5.6E-mailtrialmedonc@amc.uva.nl
    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 Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    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 Powder for concentrate for solution for injection/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 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 Yes
    D.2.1.1.1Trade name Pertuzumab
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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.3.11 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.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
    Esophageal carcinoma
    Oesofaguscarcinoom
    E.1.1.1Medical condition in easily understood language
    Esophagus cancer
    Slokdarmkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    assess the feasibility of preoperative treatment with pertuzumab and trastuzumab combined with preoperative chemoradiation (carboplatin, paclitaxel and radiation) in terms of withdrawal rate from surgery
    de haalbaarheid van preoperatieve behandeling met pertuzumab en trastuzumab in combinatie met preoperatieve chemoradiotherapie (carboplatine, paclitaxel en radiotherapie) bepalen van percentage dat niet voor ok gaat
    E.2.2Secondary objectives of the trial
    • To assess toxicities of pertuzumab and trastuzumab alone and in combination with chemoradiation.
    • To assess post-operative complications.
    • To assess pathological response.
    • To assess R0 resection rate.
    • To assess pharmacokinetics of pertuzumab and trastuzumab.
    • Om de toxiciteit van pertuzumab en trastuzumab alleen en in combinatie met chemoradiotherapie te beoordelen.
    • Om postoperatieve complicaties te beoordelen.
    • Om pathologische respons te beoordelen.
    • Om R0 resecties te beoordelen.
    • Om farmacokinetiek van pertuzumab en trastuzumab beoordelen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically proven adenocarcinoma of the intrathoracic esophagus or gastro esophageal junction.
    - HER2-positive tumor defined as either IHC 3+ or IHC 2+, the latter in combination with ISH+, as assessed by the sponsor-designated central laboratory on a primary tumor biopsy.
    - Surgical resectable (<T4b, N0-1, M0), as determined by Endoscopic Ultra Sound (EUS) and CT scan of neck, thorax and abdomen.
    - T1N1 tumors are eligible, T1N0 tumors and in situ carcinoma are not eligible
    - Tumor length longitudinal ≤ 10 cm and radial ≤ 5 cm
    - If tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction. The tumor must not extend more than 2 cm into the stomach.
    - No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula
    - Age ≥ 18 and ≤ 75 years
    - ECOG performance status 0 or 1
    - Adequate hematological, renal and hepatic functions defined as:
    o neutrophiles ≥ 1.5 x 109/L
    o platelets ≥ 100 x 109/L
    o hemoglobin ≥ 5.6 mmol
    o total bilirubin ≤ 1.5 x upper normal limit
    o creatinine ≤ 120 μmol/L
    - Adequate left ventricular ejection fraction defined as an LVEF of ≥55%.
    - Written, voluntary informed consent
    - Patients must be accessible to follow up and management in the treatment center
    - Histologisch bewezen adenocarcinoom van de intrathoracale slokdarm of gastro oesofageale overgang .
    - HER2 - positieve tumor gedefinieerd als IHC 3 + of IHC 2 + , de laatste in combinatie met ISH + , zoals beoordeeld door de sponsor - aangewezen centrale laboratorium op een primaire tumor biopsie .
    - Chirurgisch resectabel ( < T4b , N0 - 1 , M0 ) , zoals bepaald door endoscopische Ultra Sound ( EUS ) en CT-scan van de nek , de thorax en de buik .
    - T1N1 tumoren komen in aanmerking , T1N0 tumoren en in situ carcinoom komen niet in aanmerking
    - Tumor longitudinale lengte ≤ 10 cm en radial ≤ 5 cm
    - Indien de tumor zich uitbreid onder het gastro ( GE ) knooppunt in de proximale maag , moet het grootste deel van de tumor de slokdarm of GE knooppunt omvatten . De tumor mag niet meer dan 2 cm uitstrekken in de maag .
    - Geen invasie van de tracheobronchiale boom of aanwezigheid van tracheo fistel
    - Leeftijd ≥ 18 en ≤ 75 jaar
    - ECOG performance status 0 of 1
    - Adequate hematologische , nier-en leverfuncties gedefinieerd als :
    o neutrofielen ≥ 1,5 x 109 / L
    o trombocyten ≥ 100 x 109 / L
    o hemoglobine ≥ 5,6 mmol
    o totaal bilirubine ≤ 1,5 x boven de normale bovengrens
    o creatinine ≤ 120 micromol / l
    - Adequate linkerventrikel ejectiefractie gedefinieerd als een LVEF van ≥ 55 % .
    - Schriftelijke , vrijwillige geïnformeerde toestemming
    - Patiënten moeten toegankelijk zijn voor de follow-up in het behandelcentrum
    E.4Principal exclusion criteria
    - A tumour the epicenter of which in the stomach is greater than 5 cm of the GE junction or those within 5 cm of the GE junction without extension in the oesophagus are classified as gastric cancer.
    - Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated in situ carcinoma of the cervix, or malignancy more than 5 years prior to enrollment.
    - Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
    - Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
    - Previous chemotherapy, radiotherapy, treatment with an anti-HER2 antibody or with small molecule HER2 inhibitors.
    - Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before randomization.
    - Pulmonary fibrosis and/or severely impaired lung function.
    - Pre-existing motor or sensory neurotoxicity greater than WHO grade 1.
    - Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine.
    - Dementia or altered mental status that would prohibit the understanding and giving of informed consent
    - Inadequate caloric- and/or fluid intake
    - Een tumor met epicentrum in de maag groter dan 5 cm, van de GE kruising of die op 5 cm van het GE knooppunt zonder extensie in de slokdarm geclassificeerd als maagkanker .
    - In de voorgeschiedenis maligniteiten anders dan diagnose bij binnenkomst, m.u.v. niet - melanome huidkanker , of curatief behandeld in situ carcinoom van de cervix , of maligniteit meer dan 5 jaar voorafgaand aan de inclusie.
    - Zwangerschap ( positieve serum zwangerschapstest ) , plannen om zwanger te worden en het geven van borstvoeding .
    - Patiënt ( man of vrouw ) niet bereid om zeer effectieve methoden van anticonceptie (per institutionele standaard) te gebruiken tijdens de behandeling en gedurende 6 maanden (mannelijk of vrouwelijk) na het einde van de behandeling .
    - Voorbehandelin met chemotherapie , radiotherapie , behandeling met een HER2 -antilichaam of klein molecuul -HER2 remmers .
    - Klinisch significante cardiovasculaire aandoeningen (waaronder myocardinfarct , instabiele angina pectoris , symptomatisch congestief hartfalen, ernstige ongecontroleerde hartritmestoornissen ) ≤ 1 jaar vóór randomisatie .
    - Pulmonale fibrose en / of ernstig gestoorde longfunctie .
    - Reeds bestaande motorische of zintuiglijke neurotoxiciteit groter dan WHO-graad 1 .
    - Actieve infectie of andere ernstige onderliggende aandoening die het vermogen van de patiënt om de beoogde behandeling beinvloeden, inclusief eerdere allergische reacties op geneesmiddelen die Cremophor bevatten , zoals cyclosporine of teniposide.
    - Dementie of veranderde mentale toestand die het geven van geïnformeerde toestemming bemoeilijken
    - Onvoldoende calorie - en / of vochtinname
    E.5 End points
    E.5.1Primary end point(s)
    Feasibility of preoperative treatment with pertuzumab and trastuzumab combined with preoperative chemoradiation (carboplatin, paclitaxel and radiation) in terms of withdrawal rate from surgery
    Haalbaarheid van preoperatieve behandeling met pertuzumab en trastuzumab in combinatie met preoperatieve chemoradiotherapie (carboplatine, paclitaxel en straling) (wel/geen operatie)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continues during treatment and Follow up
    Continue tijdens behandeling en follow up
    E.5.2Secondary end point(s)
    • To assess toxicities of pertuzumab and trastuzumab alone and in combination with chemoradiation.
    • To assess post-operative complications.
    • To assess pathological response.
    • To assess R0 resection rate.
    • To assess pharmacokinetics of pertuzumab and trastuzumab
    Beoordelen toxiciteit van pertuzumab en trastuzumab alleen en in combinatie met chemoradiotherapie .
    • Beoordelen postoperatieve complicaties.
    • Beoordelen pathologische respons.
    • Beoordelen R0 resectie tarief.
    • Beoordelen farmacokinetiek van pertuzumab en trastuzumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continues during treatment and Follow up
    Continue tijdens behandeling en follow up
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Feasibilty
    Haalbaarheid
    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 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) 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 concerned8
    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
    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 months0
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Surgery or best supportive care
    Operatie of ondersteunende zorg
    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 Decision2014-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
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