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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   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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    EudraCT Number:2012-003181-40
    Sponsor's Protocol Code Number:2012-249
    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:2012-08-09
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-003181-40
    A.3Full title of the trial
    Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer: a multicentre randomized phase III clinical trial
    Voorbehandeling met bestraling en chemotherapie gevolgd door operatie versus alleen operatie voor operatief verwijdbare of mogelijk verwijdbare alvleesklierkanker. Eengerandomiseerd fase III onderzoek (PREOPANC studie)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preoperative chemotherapy and radiotherapy versus direct surgery in patients with pancreatic cancer: a multicentre study
    Preoperatieve chemotherapie en bestraling t.o.v. direct opereren bij patienten met alvleesklierkanker; een multicenter studie
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number2012-249
    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 SponsorFoundation for Liverdisease
    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 supportFoundation for Liverdisease
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFoundation of Liverdisease
    B.5.2Functional name of contact pointProf Dr C.H.J. van Eijck
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015CE
    B.5.4Telephone number0031107033854
    B.5.5Fax number0031107035503
    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. name Gemcitabine
    D. of the Marketing Authorisation holderEli Lilly Nederland BV
    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 Powder and solvent for solution for injection
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    patients with resectable or borderline resectable pancreatic cancer.
    patienten met een operabel of borderline operabel pancreas carcinoom

    E.1.1.1Medical condition in easily understood language
    patients with resectable or possible resectable pancreatic cancer.
    Patienten met een operabel of mogelijk operabel kankergezwel van de alvleesklier
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether the addition of preoperative radiochemotherapy to the standard treatment, consisting of explorative laparotomy, pancreaticoduodenectomy if possible, followed by adjuvant chemotherapy, improves the overall survival (analyzed by intent to treat) of patients with resectable or borderline resectable pancreatic cancer.
    Het onderzoeken of preoperative radiochemotherapie voorafgaande aan de standaard behandeling, bestaande uit exploratieve laparotomie gevolgd door pancraticoduodenectomie indien mogelijk, en adjuvante chemotherapie, de overall survival verbetert (geanalyseerd door intent to treat) van patienten met een operabel of borderline operabel pancreas carcinoom

    E.2.2Secondary objectives of the trial
    to compare between the study arms
    - the resection rate
    - the microscopically complete (R0) resection rate
    - the disease free survival
    - the time to locoregional failure
    - the time to distant metastases
    - the postoperative complications and morbidity
    To assess in experimental arm
    - the radiological response rates after preoperative radiochemotherapy (RECIST criteria)
    - the pathological response rates after preoperative radiochemotherapy
    - the toxicity of preoprative radiochemotherapy according to Common Terminology Criteria of Adverse Events 4 (CTC-AE-4)
    - de resectie maatstaf wordt gedefinieerd als het percentage van in aanmerking voor randomisatie komende patienten die daadwerkelijk een resectie ondergaan. Patienten die helemaal geen exploratieve laparotomie ondergaan of een exploratieve laparotomie maar geen resectie worden beschouwd als een mislukking.
    - RO resectie maatstaf wordt gedefinieerd als het percentage van in aanmerking komende patienten die een microscopisch complete (of RO) rescetie ondergaan. .
    - Ziektevrij overleven wordt gedefinieerd als overleven zonder duidelijk terugkerende alvleesklierkanker vanaf de datum van randomisatie, - Postoperatieve complicaties worden gedefinieerd volgens de internationaal geaccepteerde Clavien-Dindo classificatie en definities van post-operatieve complicaties na pancreas chirurgie (pancreas fistels, vertraagde ontlediging van de maag, bloeding) door de Internationale SGPC (analyse van intent-to-treeat en per-protocol by patienten dioe PD/Whipple ondergaan)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologicallyconfirmed adenocarcinoma of the pancreas
    2. Primarilly resectable tumours or Borderline resectable tumours
    3. Karnofsky performance status ≥ 70%
    4. Ability to undergo surgery and radiochemotherapy
    5. Leucocytes ≥ 3.5 X 10.9/l
    6. Platelets ≥ 100X 10.9/l
    7. Hemoglobin ≥ 6 mmol/l
    8. renal function: E-GFR > 50 ml/min
    9. Age ≥ 18 jaar
    10.Written informed concent
    11. Patients with reproductive potential must use effective contraception
    1. Histologisch of cytologische bevestigde adenocarcinoom van de pancreas
    2. Primair verwijderbare tumor of Borderline verwijderbare tumor
    3. Karnofsky performance status ≥ 70%
    4. Geschiktheid om operatie en chemotherapie te ondergaan
    5. Leucocytes ≥ 3.5 X 10.9/l
    6. Platelets ≥ 100X 10.9/l
    7. Hemoglobine ≥ 6 mmol/l
    8. Nierfunctie: E-GFR > 50 ml/min
    9. Leeftijd ≥ 18 jaar
    10.Ondertekend instemmingsformulier
    11. Patienten in de vruchtbare leeftijd moeten effectieve contraceptie gebruiken
    E.4Principal exclusion criteria
    1.T1 resectable tumours, centrally located with no connection to the SMA, Celiac axis, CHA or SMV/PV
    2. Claerly locally advanced, irresectable, tumours
    3. Carcinoma of the Papilla Vateri
    4. Co morbidity precluding surgery or radiochemotherapy
    5. Distant metastases, including cytologically prove N2 lymph node metastases (base of the celiac trunk or between inferior vena cava and aorta)
    6. Previous treatment of pancreatic cancer (i.e. radiotherapy or chemotherapy)
    7. Pregnancy
    8. Imminent bowel obstruction
    9. Active bleeding
    10 Uncontrolled infection
    11 Anamnestically known positive status for HIV or hepatitis B or C
    1.T1 operabele tumoren, centraal gelegen met geen verbinding met de SMA, Coeliakie as, CHA of SMV / PV
    2. lokaal operabele, tumoren
    3. Carcinoom van de papil Vateri
    4. Co morbiditeit die zich verzetten tegen een operatie of radiochemotherapie
    5. Metastasen op afstand, met inbegrip van cytologisch bewijzen N2 lymfeklier metastasen (basis van de coeliakie stam of tussen de onderste holle ader en de aorta)
    6. Eerdere behandeling van pancreaskanker (dat wil zeggen radiotherapie of chemotherapie)
    7. zwangerschap
    8. Dreigende darmobstructie
    9. actieve bloeding
    10 Ongecontroleerde infectie
    11 anamnese bekende positieve status voor HIV of hepatitis B of C
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival is defined as the period of time between randomization and death from any cause. Patients alive at last follow-up are censored.
    Algehele overleving deze wordt gedefinieerd tussen de periode van randomisatie en overlijden ongeacht de oorzaak. Patiënten die in leven zijn tijdens de laatste follow-up.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One of the interim analysis is planned after 100 patients have been followed until death or for at least 12 months after inclusion.

    All cause actuarial survival curves in the two randomization groups will be compared by intent to treat The log rank test statistics will be used to compare the Kaplan-Meier survical curves of two randomization groups
    E.5.2Secondary end point(s)
    - Resection rate is defined as the percentage of eligible randomized patients that actually underwent a resection. Patients that do not undergo an explorative laparotomy at all or do undergo an explorative laparotomy but not a resection are considered a failure.
    - R0 resection rate is defined as the percentage of eligible randomized patients that underwent a microscopically complete (or R0) resection. The resection is considered R0 if the inked margin is further than 1 mm distinct from any tumour cells.
    - Disease free survival is defined as survival without overt recurrent pancreatic cancer from the date of randomization, as discovered following complaints of the patient or on routine CT-scan at 6 months intervals. Any sign of recurrent or persistent disease, locoregional or distant, as well as death from any cause is considered an event for this endpoint. Patients that do not undergo an explorative laparotomy at all or do undergo an explorative laparotomy but not a resection are considered a failure at time point zero.
    - Time to locoregional failure is defined as the period of time without locoregional recurrence after randomisation. Locoregional recurrence is considered an event and patients are censored at death or distant metastases without locoregional recurrence. Patients that do not undergo an explorative laparotomy at all or do undergo an explorative laparotomy but not a resection are considered a failure at time point zero.
    - Time to distant metastases is defined as the period of time without distant metastases after randomisation. Distant metastases are considered an event and patients are censored at death.
    - Postoperative complications are defined according to the internationally-accepted Clavien-Dindo classification and definitions of post-pancreatic surgery complications (pancreatic fistula, delayed gastric emptying, bleeding) by the International Study Group on Pancreatic Surgery (analysis on intent-to-treat and per-protocol in patients undergoing PD/Whipple).
    E.5.2.1Timepoint(s) of evaluation of this end point
    One of the interim analysis is planned after 100 patients have been followed until death or for at least 12 months after inclusion.

    All cause actuarial survival curves in the two randomization groups will be compared by intent to treat The log rank test statistics will be used to compare the Kaplan-Meier survical curves of two randomization groups
    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 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. 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    compared with standard procedure chemotherapy (Gemzar) after surgery
    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 concerned14
    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
    36 months and 12 months after the last patient has been entered
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months12
    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: 244
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 244
    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 state244
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 244
    F.4.2.2In the whole clinical trial 244
    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)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Foundation for Liverdisease
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
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