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    Summary
    EudraCT Number:2018-004385-34
    Sponsor's Protocol Code Number:NeoAspMet
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-07
    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 number2018-004385-34
    A.3Full title of the trial
    Neoadjuvant Aspirin and/or Metformin during preoperative induction chemotherapy and chemoradiotherapy for locally-advanced rectal cancer. A multi-arm, multi-stage, intergroup (STAR-04/SICO-CR01/GISCAD) randomised clinical trial.
    Studio di fase 2 randomizzato dell’associazione di Asprinina e/o Metformina con la chemioterapia di induzione seguita da chemioradioterapia neoadiuvante in pazienti con carcinoma del retto localmente avanzato (NeoAspMet Trial).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized phase II trial in patients with locally advanced rectal carcinoma
    studio di fase II in pazienti con carcinoma del retto localmente avanzato
    A.3.2Name or abbreviated title of the trial where available
    NeoAspMet
    NeoAspMet
    A.4.1Sponsor's protocol code numberNeoAspMet
    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 SponsorISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
    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 supportIstituto Nazionale Tumori - Fondazione G.Pascale, IRCCS Napoli
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINT, IRCCS, G.Pascale
    B.5.2Functional name of contact pointUnità Sperimentazioni Cliniche
    B.5.3 Address:
    B.5.3.1Street AddressVia M.Semmola
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number+390815903571
    B.5.5Fax number+390817702938
    B.5.6E-mailusc-segreteria@istitutotumori.na.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 No
    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.3.1Product nameMETFORMINA
    D.3.2Product code [657-24-9]
    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.3.9.1CAS number 657-24-9
    D.3.9.2Current sponsor code211-517-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 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 holderTEVA B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameXELODA
    D.3.2Product code [154361-50-9]
    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.3.9.1CAS number 154361-50-9
    D.3.9.2Current sponsor code604-948-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number502 to 3514
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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: 3
    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 OXALIPLATINO
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA SRL
    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.3.1Product nameOXALIPLATINO
    D.3.2Product code [63121-00-6]
    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.3.9.1CAS number 63121-00-6
    D.3.9.2Current sponsor code621-248-1
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number40
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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: 4
    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.2.1.2Country 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.3.1Product nameaspirina
    D.3.2Product code [58-78-2]
    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.3.9.1CAS number 50-78-2
    D.3.9.2Current sponsor code200-064-1
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number325
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    LOCALLY ADVANCED RECTAL CANCER PATIENTS IN STAGE II/III
    Pazienti con cancro del retto localmente avanzato in stadio II/III.
    E.1.1.1Medical condition in easily understood language
    LOCALLY ADVANCED RECTAL CANCER PATIENTS IN STAGE II/III
    Pazienti con cancro del retto localmente avanzato in stadio II/III.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    Primary objective is to assess the effect of each of the 3 experimental interventions (aspirin, metformin or both, in combination with neoadjuvant induction chemotherapy (ICT) and preoperative chemoradiation (CRT)) compared to standard neoadjuvant ICT
    L’obiettivo primario è stabilire gli effetti di 3 interventi farmacologici sperimentali (aspirina, metformina o entrambi i trattamenti, in combinazione con la chemioterapia di induzione (ICT) e la radiochemioterapia (CRT))
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the effect of the experimental interventions compared to the standard neoadjuvant treatment with ICT followed by CRT
    L’obiettivo secondario è stabilire gli effetti degli interventi sperimentali in confronto al trattamento neoadiuvante standard con ICT seguito da CRT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pathologically proven diagnosis of adenocarcinoma of the rectum by endoscopic biopsy within 56 days prior to randomisation.
    Locally advanced tumour (defined as TNM Stage II or III) based upon the following minimum diagnostic workup: MRI of the pelvis, contrast-enhanced CT of abdomen and chest.
    Able to undergo induction chemotherapy, chemoradiotherapy and total mesorectal excision (TME).
    Distal part of the tumour within 0–12 cm of the anal verge (Note: intraperitoneal rectal cancer are excluded)
    •Diagnosi istopatologica di adenocarcinoma del retto, attraverso una biopsia endoscopica, entro 56 giorni prima della randomizzazione.
    •Cancro del retto localmente avanzato (definito tramite la classificazione TNM come Stadio II o III), sulla base del seguente workup diagnostico minimo: MRI della pelvi, CT torace-addome con mezzo di contrasto.
    •Non vi siano controindicazioni alla chemioterapia di induzione, radiochemioterapia ed escissione totale del mesoretto (TME).
    . parte distale del tumore entro 0-12 cm dal margine anale (nota: tumori rettali intraperitoneali sono esclusi)
    E.4Principal exclusion criteria
    Prior treatment for LARC (recurrent rectal tumours are excluded) or previous pelvic radiotherapy.
    Unequivocal evidence of established metastatic disease based on minimum diagnostic workup. Patients with equivocal lesions are eligible.
    Patients already taking daily aspirin and/or metformin for more than 4 weeks prior to randomisation.
    Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors and to any of the excipients.
    Hypersensitivity to metformin or to any of the excipients
    •Pregresso trattamento per LARC (i tumori recidivi del retto sono esclusi) o pregressa radioterapia della pelvi.
    •Evidenza inequivocabile di malattia metastatica al workup diagnostico minimo. Pazienti con lesioni equivocabili sono eleggibili.
    •Pazienti già sotto terapia quotidiana con aspirina e/o metformina da più di 4 settimane prima della randomizzazione.
    •Ipersensibilità ai composti a base di acido salicilico o inibitori delle sintesi delle prostaglandine o di qualunque altro eccipiente.
    •Ipersensibilità alla metformina o a qualunque altro eccipiente
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is Good Pathological Response (GPR) defined as Tumour downstaging (ypT0 or ypT1) irrespective of the pathological N stage
    L’Endpoint primario è la buona risposta patologica (GPR) definita come sottostadiazione del tumore (ypT0 o ypT1) indipendentemente dallo stadio patologico N.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Estimated duration of recruitment: 3 years
    Durata stimata del reclutamento: 3 anni
    E.5.2Secondary end point(s)
    • Tumor Regression Rate
    • Pathological complete responses (pCR)
    • NeoAdjuvant Rectal (NAR) score
    • MRI Tumor Downstaging (mr TGR) rate
    • Event-Free Survival (EFS)
    • Overall Survival (OS)
    • Time to Distant Recurrence (TDR)
    • Rate of local recurrence at 3 years
    • Abdominal Perineal Resection (APR) rate
    • Organ preservation rate at 3 years
    • Post-operative complications
    • Treatment-related toxicity
    • Quality of Life (QoL)
    • Simplified ESMO class risk shift after induction chemotherapy
    •Grado di regressione tumorale (TRG)
    •Risposta patologica completa (pCR)
    •Neo-Adjuvant Rectal (NAR) score
    •Tasso di Tumour Downstaging (mr TGR) alla MRI
    •Sopravvivenza libera da eventi (EFS)
    •Sopravvivenza globale (OS)
    •Tempo di comparsa di recidiva a distanza (TDR)
    •Tasso di recidiva locale a 3 anni
    •Tasso di resezioni addomino-perineali (APR)
    •Tasso di preservazione d’organo a 3 anni
    •Complicanze post-operatorie
    •Qualità di vita (QoL)
    •Tossicità correlata al trattamento
    •Tasso di cambiamento della Classe di rischio ESMO semplificata dopo la chemioterapia di induzione
    E.5.2.1Timepoint(s) of evaluation of this end point
    Estimated duration of recruitment: 3 years
    Durata stimata del reclutamento: 3 anni
    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 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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open-label, multi-centrico, multi-braccio, multi-stadio (MAMS)
    Open-label randomised, multi-institutional, multi-arm, multi-stage (MAMS
    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
    Confronto tra braccio sperimentale con il braccio di controllo
    Experimental arms vs control arm
    E.8.2.4Number of treatment arms in the trial4
    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 concerned21
    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 Information not present in EudraCT
    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
    Estimated duration of recruitment: 3 years
    Estimated duration of treatment: 24 weeks
    Estimated duration of participation: 3 years and 24 weeks
    Durata stimata del reclutamento: 3 anni
    Durata stimata del trattamento: 24 settimane
    Durata stimata della partecipazione: 3 anni e 24 settimane
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    E.8.9.2In all countries concerned by the trial months0
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state340
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 340
    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 for 3 years after completion or discontinuation of study treatment, or withdrawal of consent, or until death, whichever occurs first.
    TUTTI I PAZIENTI INSERITI NELLO STUDIO VERRANNO SEGUITI PER 3 ANNI INDIPENDENTEMENTE SE HANNO CONCLUSO LO STUDIO SE HANNO RINUNCIATO O SE HANNO INTERROTTO IL TRATTAMENTO
    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 Decision2019-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-29
    P. End of Trial
    P.End of Trial StatusOngoing
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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
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