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    Summary
    EudraCT Number:2011-005638-20
    Sponsor's Protocol Code Number:CRO-2010-14
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-005638-20
    A.3Full title of the trial
    Phase III randomized trial of preoperative radiotherapy with an integrated simultaneous boost IMRT-IGRT) versus chemoradiotherapy for T3-4 rectal cancer
    STUDIO RANDOMIZZATO DI FASE III FRA SOLA RADIOTERAPIA CON SIMULTANEOUS BOOST (IMRT-IGRT) versus CHEMIORADIOTERAPIA STANDARD NEL CARCINOMA DEL RETTO OPERABILE, STADIO T3-T4
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL COMPARING STANDARD CHEMORADIOTHERAPY VERSUS RADIOTHERAPY ALONE WITH DOSE INTENSIFICATION IN THE PREOPERATIVE APPROACH OF RECTAL CANCER
    STUDIO CLINICO CHE CONFRONTA LA CHEMIORADIOTERAPIA STANDARD CON LA SOLA RADIOTERAPIA CON INTENSIFICAZIONE DI DOSE NEL TRATTAMENTO PREOPERATORIO CARCINOMA DEL RETTO
    A.3.2Name or abbreviated title of the trial where available
    rectumSIB
    RECTUM-SIB
    A.4.1Sponsor's protocol code numberCRO-2010-14
    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 SponsorCENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
    B.1.3.4CountryItaly
    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 supportCentro di Riferimento Oncologico (CRO), IRCCS, Aviano
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro di Riferimento Oncologico (CRO), IRCCS, Aviano
    B.5.2Functional name of contact pointDr. Antonino De Paoli
    B.5.3 Address:
    B.5.3.1Street AddressVia Gallini 2
    B.5.3.2Town/ cityAviano
    B.5.3.3Post code33081
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 0434 659528
    B.5.5Fax number+39 0434 659524
    B.5.6E-mailadepaoli@cro.it
    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 XELODA*120CPR RIV 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number500
    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
    Patients with operable rectal cancer
    Pazienti affetti da carcinoma del retto operabile
    E.1.1.1Medical condition in easily understood language
    patients with rectal cancer
    pazienti affetti da tumore del retto
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10062099
    E.1.2Term Rectal neoplasm
    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
    we propose a randomized non-inferiority trial that compares preoperative FUbased
    chemoradiotherapy to radiotherapy with a simultaneous integrated boost. In case of
    non-inferiority, the latter approach is considered preferential with regard to toxicity and cost.
    The metabolic response of the tumor, as assessed by 18F-FDG PET or PET-CT, will be used
    as a surrogate marker of cause specific outcome.
    Confrontare l’efficacia, in termini di Risposta Metabolica (PET-CT), della sola Radioterapia con Simulataneous Boost (IMRT-IGRT) versus la Chemioradioterapia Standard nei pazienti con carcinoma del retto operabile, stadio T3-T4, N0-2, M0 (o metastasi resecabile).
    E.2.2Secondary objectives of the trial
    Secondary endpoints:
    􀁸 histological downgrading, according to the Dworak classification (13)
    􀁸 number of R0, R1 and R2 resections
    􀁸 acute and late toxicity, according the NCI Common Terminology Criteria for Adverse
    Events v3.0 (CTCAE)
    􀁸 local control
    􀁸 progression free survival
    􀁸 survival
    􀁸 quality of life
    􀁸 cost evaluation
    Confrontare i due trattamenti in termini di:
    - Grado di Regressione Tumorale (Dworak score)
    - Tasso di resezione R0, R1,R2
    - Tossicità acuta e tardiva (NCI-CTCAEs, versione 3.0)
    - Controllo locale di malattia
    - Sopravvivenza libera da malattia
    - Sopravvivenza globale
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    LIFE QUALITY:
    Vers:CRO_28-12-
    Date:2010/12/28
    Title:Prospective evaluation of Quality of Life in patients with rectal cancer treated with preoperative radiation therapy alone with simultaneous boost or chemoradiotherapy (IMRT-IGRT_SIB)(CRO-2010-14).
    Objectives:Evaluation and comparison of changes of impact on quality of life deriving from the two different treatment arms of the study (EORTC QLC-C30 e QLC-CR29)

    OTHER SUBSTUDIES:
    Evaluation of molecular predictive and prognostic factors on tissue and peripheral blood samples. October 2011, version 1
    QUALITA DELLA VITA:
    Vers:CRO_28-12-
    Data:2010/12/28
    Titolo:Valutazione prospettica della qualità di vita nei pazienti affetti da neoplasia del retto sottoposti a radioterapia con simultaneous boost (IMRT-IGRT_SIB) o chemio radioterapia preoperatoria e chirurgia nell’ambito dello studio Rectum SIB di fase III (CRO-2010-14).
    Obiettivi:Lo studio ha lo scopo di valutare e mettere a confronto i cambiamenti di qualità di vita nei pazienti con carcinoma del retto trattati con sola radioterapia o con chmioradioterapia(EORTC QLC-C30 e QLC-CR29)

    ALTRI SOTTOSTUDI:
    Determinazione di fattori molecolari prognostici e predittivi su campioni di tessuto e di sangue. Data: Ottobre 2011, versione 1
    E.3Principal inclusion criteria
    Eligibility criteria include histopathologically confirmed rectal adenocarcinoma with an
    inferior border within 15 cm of the anal verge. The tumor has to have evidence of T3 or T4
    disease on MRI or endoluminal ultrasound. Patients with unresectable mestastatic disease,
    with an ECOG performance status > 3 and patients not deemed fit for radiotherapy,
    capecitabine or surgery are excluded. Pregnant or lactating patients, women with child
    bearing potential who lack effective contraception and patients below 18 years old are
    excluded as well
    Criteri di inclusione

    - Pazienti con adenocarcinoma del retto, confermato dall’esame istologico
    - Polo inferiore della neoplasia ≤15 cm dal margine anale (rettoscopia)
    - Stadio T3 o T4 definito con RM o EUS
    - Esami ematochimici entro 14 giorni dall’arruolamento: Ematologia: neutrofili ≥1.5 x 109/L, piastrine &gt;100 x109/L. Biochimica: transaminasi ≤2.5 ULN e fosfatasi alcalina ≤2.5 ULN, creatinina clearance calcolata ≥ 60 mL/min. Laboratory
    - Qualsiasi condizione non controllata che precluda la possibilità di eseguire un trattamento radioterapico o chemioterapico o un intervento chirurgico
    - Malattia cardiaca non clinicamente rilevante
    - Firma del consenso informato in accordo con ICH/GCP.
    E.4Principal exclusion criteria
    - ECOG Performance status >3
    - previous pelvic radiation therapy and/or chemotherapy
    - patients with inoperable rectal cancer
    - unresectable distant metastases
    - ECOG Performance status &gt;3
    - Precedente radioterapia sull’addome o chemioterapia, o non suscettibile di intervento chirurgico.
    - Presenza di metastasi a distanza non resecabili
    - Pazienti in gravidanza o in allattamento
    - Pazienti in periodo riproduttivo senza adeguate misure contraccettive.
    - Pazienti con età &lt; 18 anni
    E.5 End points
    E.5.1Primary end point(s)
    we propose a randomized non-inferiority trial that compares preoperative FUbased
    chemoradiotherapy to radiotherapy with a simultaneous integrated boost. In case of
    non-inferiority, the latter approach is considered preferential with regard to toxicity and cost.
    The metabolic response of the tumor, as assessed by 18F-FDG PET or PET-CT, will be used
    as a surrogate marker of cause specific outcome.
    Confrontare l’efficacia, in termini di Risposta Metabolica (PET-CT), della sola Radioterapia con Simulataneous Boost (IMRT-IGRT) versus la Chemioradioterapia Standard nei pazienti con carcinoma del retto operabile, stadio T3-T4, N0-2, M0 (o metastasi resecabile).
    E.5.1.1Timepoint(s) of evaluation of this end point
    4-6 weeks after preoperative treatment
    4-6 settimane dopo il trattamento preoperatorio
    E.5.2Secondary end point(s)
    Histological tumor regression grade
    grado di regressione tumorale all'esame istologico
    E.5.2.1Timepoint(s) of evaluation of this end point
    6-8 weeks after preoperative treatment
    6-8 settimane dopo il trattamento preoperatorio
    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 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
    chemioradioterapia vs radioterapia da sola
    chemoradiotherapy vs RT alone
    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 concerned8
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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.1.1.2Preterm 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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state80
    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)
    Clinical follow-up
    Sorveglianza clinica
    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 Decision2011-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-12
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