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    The EU Clinical Trials Register currently displays   37981   clinical trials with a EudraCT protocol, of which   6230   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2016-000862-49
    Sponsor's Protocol Code Number:RG_15-011
    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:2016-05-19
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-000862-49
    A.3Full title of the trial
    Can we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can we save the rectum by watchful waiting or local surgery following (chemo)Radiotherapy versus radical surgery for early rectal Cancer?
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberRG_15-011
    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 University of Birmingham
    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 supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe University of Birmingham
    B.5.2Functional name of contact pointMr Simon Bach
    B.5.3 Address:
    B.5.3.1Street AddressSchool of Cancer Sciences, Academic Dept of Surgery
    B.5.3.2Town/ cityEdgbaston, Birmingham
    B.5.3.3Post codeB15 2TH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01216978449
    B.5.5Fax number01214721230
    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 Capecitabine
    D. of the Marketing Authorisation holderRoche Registration 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.3.1Product nameCapecitabine
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapecitabine
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number825
    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
    Early rectal cancer
    E.1.1.1Medical condition in easily understood language
    Early rectal cancer
    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
    The aim of the STAR-TREC study is to assess the feasibility of successfully recruiting to a large, multi-centre randomised trial comparing radical surgery versus organ saving treatment using (chemo)radiotherapy followed by selective transanal microsurgery.

    STAR-TREC is a phase II feasibility study that will evaluate whether it is possible to accelerate patient recruitment from 2 per month, as attained in the previous TREC study, to 6 per month over a two-year period. This would demonstrate deliverability of a phase III study incorporating 400 patients to evaluate differences in pelvic relapse rates between organ saving and standard surgery. Randomising 70-80 patients per year in phase III would achieve this target in 4 years (including patients treated in phase II).

    1. Year 1: randomise at least 4 cases per month internationally (n=48)
    2. Year 2: randomise at least 6 cases per month internationally (n=72)
    E.2.2Secondary objectives of the trial
    Secondary Objectives:

    1. Year 1: Can one international partner procure independent STAR-TREC funding? Successful international collaboration will be necessary to deliver a future phase III study of 400 patients.

    2. Year 1: Can one international partner open the STAR-TREC study to recruitment?

    3. Efficacy of organ preserving treatment arms on completion of phase II study: Is the organ saving rate > 50% at 12 months (following randomisation) in the experimental arms ? This figure is intended as a guide to both the STAR-TREC DMEC and any phase III peer review.

    4. We expect that the actual organ saving rate would lie between 60-70%. Using a target of 50% in phase II will allow for the relatively small sample size. We consider that this metric of efficacy would be suitable for early publication (with toxicity data) as it does not constitute a primary outcome for phase III.

    5. Proportion of patients undergoing primary TME surgery (control-group) accurately staged by MRI and s
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Biopsy proven adenocarcinoma of the rectum
    • mriT1-3bN0 (with ≤5mm of mesorectal invasion) rectal tumour or endorectal ultrasound defined rectal cancer uT1-uT3b (optional: in centres where high quality ERUS is available and patient unable to tolerate MRI)
    • MDT determines that all of the following treatment options are feasible: (a) TME surgery, (b) CRT (c) SCPRT d) TEM Patients with equivocal radiological lesions e.g. mesorectal, retroperitoneal, liver, lung are eligible if agreed by MDT
    • Aged 16 or over in UK (18 or over in the Netherlands and Denmark).
    • Estimated creatinine clearance >50 mls/min
    • Absolute neutrophil count >1.5x109/l; platelets >100 x 109/L
    • Serum transaminase <3 x Upper Limit Normal/l (ULN)
    • Bilirubin <1.5 x ULN
    • ECOG performance status 0-1
    • If female and of childbearing potential, must:
    o Have a negative pregnancy test ≤72hours prior to initiating study treatment
    o Agree to avoid pregnancy during and for 6 months after study treatment
    • If male with a partner of childbearing potential, must:
    o Agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment
    • Patient able and willing to provide written informed consent for the study
    E.4Principal exclusion criteria
    • Unequivocal evidence of metastatic disease (includes resectable metastases)
    • MRI node positive (defined by protocol guidelines)
    • MRI extramural vascular invasion (mriEMVI) positive (defined by protocol guidelines)
    • MRI defined mucinous tumour
    • Mesorectal fascia threatened (< 1 mm on MRI)
    • Maximum tumour diameter > 40mm as measured from everted edges on sagittal MRI
    • Tumour position anterior, above the peritoneal reflection on MRI or EUS
    • No residual luminal tumour following endoscopic resection
    • Contraindications to radiotherapy including previous pelvic radiotherapy
    • Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months prior to randomisation)
    • Known dihydropyrimidine dehydrogenase (DPYD) deficiency
    • Known Gilberts disease (hyperbilirubinaemia)
    • Taking warfarin that cannot be discontinued at least 7 days prior to starting treatment or substituted by low molecular weight heparin
    • Taking phenytoin or sorivudine or its chemically related anologues, such as brivudine (see Section 8.4.5 for further details)
    • Pregnant, lactating or pre-menopausal women not using adequate contraception.
    • Unable or unwilling to provide written informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome measure

    The primary endpoint of the STAR-TREC feasibility study is:

    • RECRUITMENT RATE - measured at 12 and 24 months.
    Target recruitment rates are ≥4 and ≥6 patients randomised per month at 12 and 24 months respectively for total accrual of 120 international cases.
    Each individual country will attempt to exceed the minimum recruitment required to sustain phase III (UK 75, the Netherlands 75, Denmark 30).

    If recruitment is on target in year two then consideration will be given to an early application for transition to phase III with a funding application and a formal protocol amendment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome is recruitment. Recruitment will be measured at 12 amd 24 months post the start of recruitment.
    E.5.2Secondary end point(s)
    The core secondary endpoints of this phase II trial are:
    • Procurement of STAR-TREC funding by one international partner
    • Opening of STAR-TREC by one international partner
    • Efficacy of organ preserving treatment arm on completion of phase II study: Is an organ saving rate > 50% at 12 months (following randomisation) achieved in the experimental arms?

    Additional outcome measures pertinent to a future phase III study examining the safety and efficacy of organ saving versus standard surgery will also be collected.
    • SAFETY
    o Accuracy of MRI in predicting STAR-TREC eligibility
    o 30-day mortality
    o 6 month mortality
    o Surgical morbidity
    o Rate of tumour recurrence or regrowth within the bowel wall (experimental arm)
    o Rate of tumour recurrence within the mesorectum (experimental arm)
    o Rate of distant metastases
    o Pelvic failure rate: expressed as a sum of the following (i) unresectable pelvic tumour, (ii) cases requiring beyond TME surgery or (iii) tumour recurrence or regrowth ≤1mm from the circumferential surgical margin after TME surgery.
    o Bowel, bladder and sexual dysfunction (measured by EORTC QLQ CR29 & C30, LARS score and ICIQ-MLUTS)

    o Proportion of patients with/ without a stoma at one year
    o Histopathological assessment of tumour down-staging following radiotherapy according to depth of tumour invasion and the incidence of other high-risk features in comparison to non-irradiated (control) group.
    o Proportion of patients identified by clinical and MRI assessment as suitable for active monitoring
    o Conversion rates from organ saving to radical surgery
    o Disease free survival
    o Quality of life (measured by EORTC QLQ CR29 & C30, EuroQol EQ-5D, LARS score and ICIQ-MLUTS)
    o Overall survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    The core secondary endpoints of this phase II trial are:
    • Procurement of STAR-TREC funding by one international partner
    • Opening of STAR-TREC by one international partner
    • Efficacy of organ preserving treatment arm on completion of phase II study: Is an organ saving rate > 50% at 12 months (following randomisation) achieved in the experimental arms?

    These main secondary ouctomes will all be measured at 12 months.
    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
    Feasibility of recruitment
    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) 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 No
    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. description
    Standard surgery
    E.8.2.4Number of treatment arms in the trial3
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 trial will be 12 months after the last data capture, i.e. 12 months after date of the last visit of the last patient undergoing the protocol based therapy. Long-term follow-up, to at least 5 years after randomisation of the last patient, constitutes the non-interventional phase of the trial.

    This will allow sufficient time for the completion of protocol procedures, data collection and data input.
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    Not Applicable.

    All participants in STAR-TREC will receive either Surgery, with two thirds of the patients also receiving either radiotherapy or chemo-radiotherapy.

    The end of treatment for each patient is surgery. Therefore there will not be anything withheld after the research has finished. All patients will be followed up as per clinical practice.
    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 Decision2016-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-22
    P. End of Trial
    P.End of Trial StatusOngoing
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