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    Summary
    EudraCT Number:2016-000862-49
    Sponsor's Protocol Code Number:RG_15-011
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-07-28
    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 ConcernedBelgium - FPS Health-DGM
    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
    STAR-TReC
    A.4.1Sponsor's protocol code numberRG_15-011
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN14240288
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02945566
    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 pointTrial Office
    B.5.3 Address:
    B.5.3.1Street AddressCancer Research UK Clinical Trial Unit (CRCTU), Institute of Cancer & Genomic Sciences
    B.5.3.2Town/ cityEdgbaston, Birmingham
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01214143973
    B.5.5Fax number01214721230
    B.5.6E-mailSTAR-TREC@trials.bham.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Capecitabine
    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.3.2Product code L01BC06
    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 154361-50-9
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    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 aims of the STAR-TREC phase III study are to evaluate whether (a)
    either a CRT or SCRT organ-saving strategy is superior in terms of
    achieving organ preservation, requirement for further surgery,
    treatment related toxicity, healthrelated quality of life, and other
    outcomes; (b) either or both organ-saving strategies lead to an
    acceptable rate of organ preservation of at least 50%.
    E.2.2Secondary objectives of the trial
    - Demonstrate efficacy and low toxicity of mesorectal radiation fields for
    treatment of early rectal cancer.
    - Establish safety of mesorectal radiation and selective transanal
    microsurgical excision for organ preservation in early rectal cancer.
    - Establish the safety and efficacy of non-operative management of CR in
    the context of early rectal cancer treatment.
    - Compare the toxicity and quality of life outcomes for patients
    undergoing standard TME surgery with those who receive
    organpreserving
    treatments.
    - Investigate the potential of genomic markers in blood (ctDNA),
    associated with persistence of tumour tissue, to facilitate the selection
    of patients for an organ saving approach based upon the likelihood of
    treatment success.
    - Evaluate the utility of ctDNA for determination of partial versus
    complete response
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Biopsy proven adenocarcinoma of the rectum
    • MRI-defined ≤T3b (with ≤5mm of mesorectal invasion) rectal tumour
    or endorectal ultrasound-defined ≤uT3b rectal cancer (optional: in
    centres where high quality endorectal ultrasound (ERUS) is available or
    patient unable to tolerate MRI)
    • MDT determines that all of the following treatment options are
    reasonable and feasible: (a) TME surgery, (b) CRT (c) SCRT (d) TEM.
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    • For patients choosing organ preservation only:
    o If female and of childbearing potential, must:
    - Have a negative pregnancy test within 7 days prior to study entry
    - Agree to use adequate, medically approved, contraceptive precautions
    from trial entry until 6 months after the end
    of study treatment
    o If non-sterilised male male with a partner of childbearing potential,
    must:
    - Agree to use adequate, medically approved, contraceptive precautions
    from trial entry until 6 months after the end of study treatment
    • Patient able and willing to provide written informed consent for the
    study E4.
    E.4Principal exclusion criteria
    • Concomitant or previous malignancies within 3 years prior to trial
    entry, except those that in the opinion of the MDT are unlikely to relapse
    within 3 years or lead to death within 5 years
    • Unequivocal evidence of metastatic disease (includes resectable
    metastases) Patients with equivocal radiological lesions (e.g.
    retroperitoneal, liver, lung) that are not classified as M1 are eligible if
    agreed by MDT
    • MRI node positive (≥N1, defined by protocol guidelines) Patients with
    equivocal radiological findings that are either classified as NX or N0 are
    eligible
    • MRI extramural vascular invasion (mriEMVI) positive (defined by
    protocol guidelines)
    • MRI defined mucinous tumour
    • Mesorectal fascia threatened (≤1 mm on MRI or ERUS)
    • Maximum tumour diameter > 40mm (either measured from everted
    edges on sagittal MRI or on ERUS)
    • 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 or arrhythmia
    within 6 months prior to trial entry)
    • Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
    • Known Gilbert's disease (hyperbilirubinaemia)
    • Taking coumarin-derivative anticoagulants (e.g. 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, within 4 weeks of trial entry (see Section 8.3.5 for
    further details)
    • Taking metronidazole at study entry
    • Pregnant or lactating women
    • History of severe and unexpected reactions to fluoropyrimidine
    therapy
    • Age <16 years (UK), <18 years (other countries)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the STAR-TREC phase III study is the proportion
    of patients with successful organ preservation at 30 months from the
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    start day of (chemo)radiotherapy treatment. This endpoint will be
    assessed for patients who prefer organ preservation and is defined as an
    in-situ rectum (includes patients subject to transanal local resection), no
    defunctioning stoma and an absence of active loco-regional cancer
    failure. The expected
    incidence of this outcome is approximately 60%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 months
    E.5.2Secondary end point(s)
    A) Randomised comparison between organ-preserving strategies:
    • Clinician-reported acute treatment related toxicity up to 30 days
    following completion of (chemo)radiotherapy
    • Proportion of patients with CR to (chemo)radiation therapy
    • Proportion of patients undergoing transanal local excision
    • Time to event of organ loss assessed for patients who prefer organ
    preservation; defined as the length of time from the start date of trial
    treatment until TME surgery
    • Non-regrowth pelvic tumour control to 36 months; defined as the
    length of time from the start date of trial treatment until death (any
    cause) or development of unequivocal pelvic recurrence but not
    including patients who developed local regrowth which was resected
    with clear margins using standard TME surgery
    • Metastasis free survival to 36 months; defined as the length of time
    from the start date of trial treatment until death (any cause) or
    detection of distant metastasis
    • Non-regrowth -disease free survival to 36 months; defined as the
    length of time from the start of trial treatment until death (any cause),
    detection of local pelvic recurrence or distant metastasis but not
    including patients who developed local regrowth which was resected
    with clear margins using standard TME surgery
    • Overall survival to 60 months defined as the length of time from the
    start date of trial treatment until death (any cause)
    B) Analyses incorporating the standard surgery comparator (phase II:
    randomised comparison; phase III: nonrandomised comparison):
    • Clinician-reported acute treatment related toxicity up to 30 days
    following completion of (chemo)radiotherapy or date of initial surgery
    • Non-regrowth pelvic tumour control to 36 months; defined as the
    length of time from the start date of (chemo)radiotherapy or date of
    initial surgery until death (any cause) or development of unequivocal
    pelvic recurrence but not including patients who preferred organ
    preservation and developed local regrowth which was resected with
    clear margins using standard TME surgery
    • Metastasis-free survival to 36 months; defined as the length of time
    from the start date of trial treatment or date of initial surgery until death
    (any cause) or detection of distant metastasis
    • Disease-free survival to 36 months; defined as the length of time from
    the start date of trial treatment or date of initial surgery until death (any
    cause), detection of local pelvic recurrence or distant metastasis but not
    including patients who developed local regrowth which was resected
    with clear margins using standard TME surgery
    • Overall survival to 60 months defined as the length of time from the
    start date of trial treatment or date of initial surgery until death (any
    cause))
    • Decision regret at 24 months, measured using the validated Decision
    regret scale questionnaire/Treatment decision questionnaire.
    C) Secondary endpoint for analyses of patient-reported outcomes
    including symptomatic toxicity and health-related quality of life (HRQoL)
    at baseline and 3, 12, 24 and 36 months after the
    start of trial-specific treatment:
    o EORTC QLQ-C30
    o EORTC QLQ-CR29
    o EuroQoL EQ-5D-3L
    o ICIQ-MLUTS
    o ICIQ-FLUTS
    o Low Anterior Resection Syndrome (LARS) Score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Toxicity up to 30 days following completion of (chemo)radiotherapy
    treatment or date of initial surgery
    Non-regrowth pelvic tumour control at 36 months
    Metastasis-free survival at 36 months
    Disease-free survival at 36 months
    Overall survival at 60 months
    Decision regret at 24 months
    HRQoL at 3, 12, 24 and 36 months compared to baseline
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    Standard surgery
    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.8.2.4Number 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years12
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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.
    Patients will revert to local standards of care.
    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 Decision2022-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-24
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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