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    Summary
    EudraCT Number:2013-002563-25
    Sponsor's Protocol Code Number:VEGF-RTX-2013
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-09-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-002563-25
    A.3Full title of the trial
    Pilot study to determine the effect of fractionated radiotherapy on expression of pro-angiogenic factors in oeshophagus carcinoma
    Een pilot studie om het effect te onderzoeken van gefractioneerde radiotherapie op de expressie van pro-angiogene factoren in oesofagus carcinoom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To study the effect of daily irradiation on the growth of blood vessels in cancer of the gullet
    Bestuderen van het effect van dagelijkse bestraling op de groei van bloedvaten bij slokdarm kanker
    A.3.2Name or abbreviated title of the trial where available
    Angiogenic factor expression during fractionated irradiation
    Expressie pro-angiogene factor tijdens gefractioneerde bestraling
    A.4.1Sponsor's protocol code numberVEGF-RTX-2013
    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 SponsorVU University Medical Centre
    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 supportVU University Medical Centre
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Centre
    B.5.2Functional name of contact pointSecretariaat Medische Oncologie
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310204444321
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody against human Vascular Endothelial Growth Factor (VEGF)
    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
    Angiogenesis in esophageal cancer
    Angiogenese in oesofagus carcinoom
    E.1.1.1Medical condition in easily understood language
    Formation of blood vessels in cancer of the gullet
    nieuwvorming van bloedvaten bij slokdarmkanker
    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 10015362
    E.1.2Term Esophageal cancer
    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 10030151
    E.1.2Term Oesophageal cancer
    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
    First primary objective: To determine the time point of induction of VEGF expression in the tumour tissue of oesophagus carcinomas during chemoradiation.
    Second primary objective: To determine whether the tumour promoting effects of this induction of VEGF expression can be inhibited by administration of bevacizumab.
    Het onderzoek heeft 2 hoofddoelen:
    1) Het bepalen van het tijdpunt van inductie van vascular endothelial growth factor (VEGF) expressie in het tumor weefsel van oesofagus carcinoom, gedurende chemoradiatie.
    2) Bepalen of het effect van VEGF of de tumorbloedvaten kan worden gestopt door de toevoeging van bevacizumab bij de behandeling.
    E.2.2Secondary objectives of the trial
    (1) Determination of mRNA expression levels of other pro-angiogenic factors than VEGF and factors that may influence radiosensitivity in the tumour tissue.
    (2) Determination of protein expression of pro-angiogenic factors and factors that may influence radiosensitivity in the tumour tissue with IHC.
    (3) Determination of Epstein Barr virus (EBV) status in the tumour tissue.
    (4) Quantification of vascular parameters in the tumour tissue to assess on-going angiogenesis.
    (5) Measurement of the plasma concentration of pro-angiogenic factors to determine if this correlates with the expression levels in the tumour tissue.
    (6) Determination of the expression level of angioregulatory miRNAs in the tumour tissue to assess whether this is affected during neoadjuvant chemoradiation.
    (7) Immune cell profiling by flow cytometric analysis (FACS)
    (1) bepalen van de mRNA expressie in de tumor van andere pro-angiogene factoren, en van factoren die de gevoeligheid van radiotherapie kunnen beinvloeden.
    (2) Bepalen van de eiwitexpressie van pro-angiogene factoren en van factoren die de gevoeligheid van radiotherapie kunnen beinvloeden, met behulp van immunohistochemistry (IHC).
    (3) Bepalen van Epstein Barr virus (EBV) status in het tumor weefsel.
    (4) Quantificeren van actieve angiogenese in het tumor weefsel, door middel van het bepalen van verschillen vasculaire uitkomstmaten.
    (5) Meten van plasma concentraties van verschillende pro-angiogene factoren, om te bepalen of dit correleert met de expressie niveaus in de tumor.
    (6) Bepalen van de expressie niveau van verschillende angioregulatoire micro RNA's (miRNA) in het tumor weefsel.
    (7) De populatie van afweercellen kwantificeren middels flow cytometric analysis (FACS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Patients that will receive standard chemoradiation treatment before surgery for oesophageal adenocarcinoma
    (2) Ability to give informed consent
    (3) Age 18 years or older
    (1) Patienten met primair oesofagus adenocarcinoom die standaard chemoradiatie krijgen vooraf aan chirurgie
    (2) Mogelijkheid om informed consent te geven
    (3) Leeftijd is 18 jaar of ouder
    E.4Principal exclusion criteria
    (1) Evidence of bleeding diathesis, coagulopathy, prolonged INR or PTT
    (2) Pregnancy
    (3) Inflammation of the gastro-intestinal tract
    (4) Brain metastasis
    (5) Diastolic/ systolic Hypertension (>90/>140 mmHg), not responding to treatment
    (6) Arterial thromboembolism in medical history
    (7) Surgery within the month prior to start of bevacizumab treatment
    (1) Bloedstollingsstoornissen, verlengde INR of PTT.
    (2) Zwangerschap
    (3) Ontsteking in het maag-darm stelsel
    (4) Hersenmetastase
    (5) Diastolysische of systolische hypertensie (>90/>140mmHg), dat niet reageert op behandeling
    (6) arteriele trombose in de ziekte geschiedenis
    (7) Chirurgie binnen 2 maanden vooraf aan de behandeling met bevacizumab
    E.5 End points
    E.5.1Primary end point(s)
    The primary parameter is the alteration of the VEGF expression on mRNA level in the tumour before and during the course of neoadjuvant chemoradiation. In addition, in the bevacizumab treated cohort, the primary parameter is the activity (phosphorylation) of the VEGF receptor (VEGFR) in the tumour tissue obtained with biopsy and the microvessel density of the resection material of the tumour.
    De primaire uitkomstmaat is de verandering van VEGF expressie op mRNA niveau in de tumor vooraf aan de behandeling vergeleken met de expressie gedurende de chemoradiatie. Tevens zal in het bevacizumab cohort de activiteit (phosphorylatie) van VEGF receptor in het tumor weefsel bepaald worden dat verkregen is bij het biopt, en de vaatdichtheid van de tumor in het weefsel dat bij resectie is weggehaald.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1st timepoint: after study biopsy of the tumour during the chemoradiation treatment.
    2nd timepoint: after the surgical resection of the residual tumour.
    1ste tijdpunt: na afname van de studie-biopt van de tumor tijdens de chemoradiatie.
    2e tijdpunt: na de chirurgie resectie van het overgebleven tumourweefsel.
    E.5.2Secondary end point(s)
    (1) mRNA expression levels of other pro-angiogenic factors than VEGF and factors that may influence radiosensitivity in the tumour tissue.
    (2) Protein expression of pro-angiogenic factors and factors that may influence radiosensitivity in the tumour tissue with IHC.
    (3) Epstein Barr virus (EBV) status in the tumour tissue.
    (4) Quantification of vascular parameters in the tumour tissue to assess on-going angiogenesis.
    (5) Plasma concentration of pro-angiogenic factors
    (6) Expression level of angioregulatory miRNAs in the tumour tissue
    (7) Immune cell profiling by flow cytometric analysis (FACS)
    (1) mRNA expressie in de tumor van andere pro-angiogene factoren, en van factoren die de gevoeligheid van radiotherapie kunnen beinvloeden.
    (2) Eiwitexpressie van pro-angiogene factoren en van factoren die de gevoeligheid van radiotherapie kunnen beinvloeden, met behulp van immunohistochemistry (IHC).
    (3) Epstein Barr virus (EBV) status in het tumor weefsel.
    (4) Quantificeren van actieve angiogenese in het tumor weefsel.
    (5) Plasma concentraties van verschillende pro-angiogene factoren, om te bepalen of dit correleert met de expressie niveaus in de tumor.
    (6) Expressie niveau van verschillende angioregulatoire micro RNA's (miRNA) in het tumor weefsel.
    (7) De populatie van afweercellen kwantificeren middels flow cytometric analysis (FACS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1st timepoint: after study biopsy of the tumour during the chemoradiation treatment.
    2nd timepoint: after the surgical resection of the residual tumour.
    1ste tijdpunt: na afname van de studie-biopt van de tumor tijdens de chemoradiatie.
    2e tijdpunt: na de chirurgie resectie van het overgebleven tumourweefsel.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) 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 concerned3
    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 trial will be terminated if no enhanced VEGF expression on mRNA level is found during the first 4 weeks of chemoradiation. If enhanced VEGF expression is found, the last cohort of patients will also receive bevacizumab during fractionated irradiation, to study the effect on angiogenesis in the tumour. After the bevacizumab cohort the study will be closed.
    De studie zal beeindigd worden als er geen verhoogde VEGF expressie op mRNA niveau wordt gevonden tijdens de eerste 4 weken van chemoradiatie. Als er wel een verhoogde expressie wordt geobserveerd, zal het laatste cohort van patienten ook bevacizumab bij hun bestaande therapie krijgen, gedurende de gefractioneerde radiotherapie. Hiermee zal het effect van bevacizumab op angiogenese in de tumour onderzocht worden. Na het bevacizumab cohort zal de studie gesloten worden.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state50
    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
    geen
    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 Decision2013-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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