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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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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    Summary
    EudraCT Number:2014-002382-30
    Sponsor's Protocol Code Number:RDD677
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-07-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-002382-30
    A.3Full title of the trial
    Phase II study of neoadjuvant cisplatin and gemcitabine chemotherapy versus upfront surgery in patients with resectable proximal biliary tract cancer:
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial of upfront chemotherapy followed by surgical resection in patients witk biliary tract cancer
    A.3.2Name or abbreviated title of the trial where available
    BBC
    A.4.1Sponsor's protocol code numberRDD677
    A.5.4Other Identifiers
    Name:Sponsors R&D RefNumber:RDD677
    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 SponsorThe Clatterbridge Cancer Centre NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportNorth West Cancer Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLiverpool Cancer Trials Unit
    B.5.2Functional name of contact pointSenior Trial Co-ordinator
    B.5.3 Address:
    B.5.3.1Street AddressWaterhouse Building, 1-3 Brownlow Street
    B.5.3.2Town/ cityLiverpool
    B.5.3.3Post codeL69 3GL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01517948974
    B.5.5Fax number01517948930
    B.5.6E-mailg.simpson@liv.ac.uk
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Gemzar
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Company
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.2Product code SUB02324MIG
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 INNGemcitabine Hydrochloride
    D.3.9.1CAS number 122111-03-9
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200 to 1000
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Cisplatin
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.2Product code SUB07483MIG
    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 CodeAS2
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Resectable Biliary Tract Carcinoma
    E.1.1.1Medical condition in easily understood language
    Biliary Tract Cancer that maybe removed by surgery
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10017621
    E.1.2Term Gallbladder carcinoma localized
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10008593
    E.1.2Term Cholangiocarcinoma
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10034446
    E.1.2Term Periampullary carcinoma resectable
    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 assess if chemotherapy followed by curative surgical resection increases overall survival rates in patients with biliary tract cancer when compared to surgery alone.
    E.2.2Secondary objectives of the trial
    • To assess the patient's response to the chemotherapy.
    • To assess the safety of surgery
    • To assess quality of life during and after treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) A centrally confirmed histopathological / cytological diagnosis of biliary tract carcinoma
    b) Radiological confirmation of intrahepatic/hilar location
    c) ECOG performance status 0, 1, or 2
    d) Age ≥ 18
    e) Estimated life expectancy > 3 months
    i. Adequate haematological function:
    ii. Haemoglobin * 10 g/dl*
    iii. White blood cell count (WBC) * 3.0 x 109/L
    iv. Absolute neutrophil count (ANC) * 1.5 x 109/L
    v. Platelet count * 100 x 109/L
    vi. *prior transfusions for patients with low haemoglobin are allowed
    f) Adequate liver function:
    i. Total bilirubin ≤1.5 x upper limit of normal (ULN) (except for patients with known documented cases of Gilbert’s syndrome)
    ii. ALT and/or AST  2.5 x ULN (If liver metastases are present, ALT or AST < 5 x ULN)
    iii. Alkaline phosphatase  5 x ULN
    g) Adequate renal function:
    i. Serum urea < 1.5 x ULN
    ii. Serum creatinine < 1.5 x ULN
    iii. Calculated GFR (greater or equal to) 40 mL/min using the Cockcroft-Gault formula
    h) No evidence of active uncontrolled infection (patients on long-term antibiotics are eligible provided signs of active infection have resolved)
    i) Women of child-bearing potential must have a negative pregnancy test prior to study entry AND be using two methods of adequate contraception, which must be continued for 3 months after completion of treatment. Reliable methods of contraception should be used consistently and correctly. Acceptable methods include barrier methods, implants, injectables, combined oral contraceptive methods, some intra-uterine devices (IUDs), sexual abstinence or vasectomised partner.
    j) Patient must have given written informed consent
    E.4Principal exclusion criteria
    a) Radiological evidence suggesting inability to resect with curative intent whilst maintaining adequate vascular inflow and outflow, and sufficient future liver remnant
    b) Radiological evidence of direct invasion into adjacent organs
    c) Radiological evidence of extrahepatic metastatic disease
    d) Significant haemorrhage (>30 mL bleeding/episode in previous 3 months) or haemoptysis (>5 mL fresh blood) within 4 weeks of recruitment.
    e) Patients with history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilise blood pressure
    f) Incomplete recovery (CTCAE grade >1) from previous anti-cancer therapy side effects (except haematological toxicity – see inclusion criteria for adequate haematological function), or alopecia
    g) Prior systemic chemotherapy for locally advanced or metastatic biliary disease is not allowed.
    h) Unresolved biliary tree obstruction
    i) Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
    j) Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart, unless urinary protein <1.5 g in a 24-hour period or protein/creatinine ratio < 1.5
    k) Mean QTc with Bazetts correction >480 msec in screening ECG or history of familial long QT syndrome
    l) Recent (<14 days) major thoracic or abdominal surgery prior to recruitment, or a surgical incision that is not fully healed
    m) Pregnant or breast-feeding women
    n) Known risk of the patient transmitting HIV, hepatitis B or C via infected blood
    o) Treatment with an investigational drug within 30 days prior to recruitment
    p) Other concomitant anti-cancer therapy (except steroids)
    q) Patients undergoing current treatment with curative intent
    r) History of prior malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously)
    s) Any psychiatric or other disorder likely to impact on informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall survival is defined as the time from randomization to the earliest of death, trial closure or date of last visit (in the case of patients lost to follow-up before trial closure). Patients lost to follow-up or alive at trial closure will be censored at the date of last visit or trial closure date (as appropriate).
    E.5.2Secondary end point(s)
    - Pathological Response
    - Surgical Safety
    - Objective Response Rate
    - Resection with Curative Intent (R)
    - Quality of Life
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Pathological Response - will be assessed locally using the Rubbia-Brandt system post resection

    - Surgical Safety will be assessed 90-day post surgery using Dindo-Clavien grading system

    - Objective Response Rate - Measured using RECIST criteira v1.1. CT scans will be at M3 (±1w), M6 (±1w), M9 (±1w), M12 (±1w), and 6 monthly until the patient's progression.

    - Resection with Curative Intent (R0)- each resection will be classed as Pathological R0 or otherwise and a local pathological review of all resections will be undertaken post resection.

    - Quality of Life - EORTC Bil 21 QLQ30 and 8D questionnaires will be collected will be at M3 (±1w), M6 (±1w), M9 (±1w), M12 (±1w), and 6 monthly until the patient's progression and will be used to permit estimation of incremental QALYs
    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.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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    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 concerned6
    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 Yes
    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 end of the trial will be five years after enrolment of the final patient or once all patients have died, whichever comes first.
    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 months11
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 22
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 50
    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 state72
    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)
    Patients will be followed up 12 months after their surgery. After these 6 months 
    the patient will be followed according to local protocol.
    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 North West Coast
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-23
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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