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    The EU Clinical Trials Register currently displays   44363   clinical trials with a EudraCT protocol, of which   7387   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:2006-006532-21
    Sponsor's Protocol Code Number:40054-22062
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-25
    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 number2006-006532-21
    A.3Full title of the trial
    Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer (PETACC-6)
    A.3.2Name or abbreviated title of the trial where available
    PETACC-6
    A.4.1Sponsor's protocol code number40054-22062
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEuropean Organization for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Eloxatin
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Synthelabo 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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNOXALIPLATIN
    D.3.9.1CAS number 61825943
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 /
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    locally advanced rectal cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10038050
    E.1.2Term Rectal cancer stage III
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10038049
    E.1.2Term Rectal cancer stage II
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether the addition of oxaliplatin to preoperative fluoropyrimidine-based chemoradiation and postoperative fluoropyrimidine-based chemotherapy improves disease-free survival in patients with locally advanced rectal cancer. Disease-free survival is defined as the interval from randomization to loco-regional failure, metastatic recurrence, the appearance of a secondary colorectal cancer or death, whichever occurs first.
    E.2.2Secondary objectives of the trial
    secondary objectives are to compare the two treatment arms with respect to overall survival, loco-regional failure, distant failure, pathological down-staging (ypT0-2N0) rate, pathological complete remission (ypT0N0) rate, tumor regression grade, histopathological R0 resection rate, sphincter preservation rate, perioperative complication rate, toxicity (CTC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patients with histologically proven adenocarcinoma of the rectum (tumour ≤ 12
    cm from the anal verge as assessed by rigid proctoscopy).
    ¨ Clinical tumour stage T3/4 or any node-positive disease (clinical stage according the TNM
    classification system (Appendix J), positive nodes as diagnosed on endorectal ultrasound and/or
    MRI). Tumour is staged by preferably a high resolution MRI. If MRI is not available,
    locoregional staging must be performed by computed tomography plus endorectal ultrasound.
    ¨ No evidence of metastatic disease (as evidenced by negative CT-scan of the chest and
    abdomen).
    ¨ The disease must be considered either resectable at the time of entry or expected to become
    resectable after preoperative chemoradiation.
    ¨ Age ≥ 18 years.
    ¨ WHO/ECOG Performance Status ≤ 2
    ¨ No prior cytotoxic chemotherapy or radiotherapy for rectal cancer.
    ¨ No prior radiotherapy to the pelvis, for any reason.
    ¨ Presence of adequate contraception in fertile patients. Adequate methods of contraception are:
    intra-uterine device, hormonal contraception, condom use with spermicide. Pregnant or
    breastfeeding women are excluded from participation.
    ¨ Adequate bone marrow, hepatic and renal function:
    ¨ Haemoglobin ≥ 10.0 g/dL (transfusions allowed to achieve or maintain levels), absolute
    neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L,
    ¨ ALAT, ASAT ≤ 2.5 x ULN,
    ¨ Alkaline phosphatase ≤ 2.5 x ULN,
    ¨ Total bilirubin ≤ 1.5 x ULN,
    ¨ Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault) and
    ¨ Creatinine ≤ 1.5 x ULN.
    ¨ Ability to swallow tablets.
    ¨ Patient must not have been treated with any investigational drug, agent nor procedure, (i.e. did
    not participate in another trial within 4 weeks) before entry in this trial.
    No previous (within the last 5 years) or concurrent malignancies, with the exception of
    adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell carcinoma of the
    skin.
    ¨ No clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic
    coronary artery disease and cardiac arrhythmia not well controlled with medication) or
    myocardial infarction within the last 12 months.
    ¨ No known allergy or any other adverse reaction to any of the study drugs or to any related
    compound.
    ¨ No known dihydropyrimidine dehydrogenase deficiency.
    ¨ No known significant impairment of intestinal resorption (e.g. chronic diarrhoea, inflammatory
    bowel disease).
    ¨ No pre-existing condition which would deter chemoradiotherapy or radiotherapy, i.e. fistulas,
    severe ulcerative colitis (particularly patients currently taking sulphasalazine), Crohn’s disease,
    prior adhesions.
    ¨ No peripheral neuropathy ≥ grade 2 (according to CTCAE v3.0)
    ¨ No serious uncontrolled intercurrent infections or other serious uncontrolled concomitant
    disease.
    ¨ No organ allograft requiring immunosuppressive therapy.
    ¨ No requirement for concurrent use of the antiviral agent sorivudine or chemically related
    analogues, such as brivudine.
    ¨ No history of uncontrolled seizures, central nervous system disorders or psychiatric disability
    judged by the investigator to be clinically significant precluding informed consent or interfering
    with compliance for oral drug intake.
    ¨ No psychological, familial, sociological or geographical condition potentially hampering
    compliance with the study protocol and follow-up schedule (these conditions should be
    discussed with the patient before registration in the trial).
    ¨ Patients can only be randomized once in this trial.
    ¨ Written informed consent before randomization according to ICH-GCP, and local, national and
    international regulations.
    E.4Principal exclusion criteria
    -severe renal impairment (creatinine clearance below 30 ml/min)
    -pregnancy and lactation
    -hypersensitivity to capecitabine or 5-FU or to any of the excipients
    -patients with history of severe and unexpected reactions to fluoro pyrimidine therapy
    -patients with known dihydropyrimidine dehydrogenase (DPD) deficiency
    -patients with severe leucopenia, neutropenia and thrombocytopenia
    -severe hepatic impairment
    -concomittant use of sorivudine or its chemically related analogues such as brivudine
    -patients with known allergy against oxaliplatin or other platinum compounds
    -patients with impaired bone marrow function
    -patients with pre-excisting peripheral neuropathy
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is disease-free survival
    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 Yes
    E.6.5Efficacy Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA140
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    as defined in the protocol (page 80)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months8
    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.1.3Elderly (>=65 years) Yes
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1060
    F.4.2.2In the whole clinical trial 1090
    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)
    normal treatment of the condition
    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 Decision2008-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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