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    Summary
    EudraCT Number:2021-001206-29
    Sponsor's Protocol Code Number:ShorTrip
    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:2021-08-17
    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 number2021-001206-29
    A.3Full title of the trial
    ShorTrip study - Phase II study of Short-course radiotherapy followed by consolidation chemotherapy with the Triplet FOLFOXIRI as total neoadjuvant therapy for locally advanced rectal cancer.
    ShorTrip - Studio di fase II di radioterapia Short-course seguita da chemioterapia di consolidamento con la Tripletta FOLFOXIRI come terapia neadiuvante totale per il tumore del retto localmente avanzato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Short-course radiotherapy followed by chemotherapy as treatment pre surgery for locally advanced rectal cancer.
    STUDIO DI RADIOTERAPIA SHORT-COURSE SEGUITA DA CHEMIOTERAPIA COME TRATTAMENTO PRECEDENTE ALL’INTERVENTO CHIRURGICO PER IL TUMORE DEL RETTO LOCALMENTE AVANZATO.
    A.3.2Name or abbreviated title of the trial where available
    ShorTrip
    ShorTrip
    A.4.1Sponsor's protocol code numberShorTrip
    A.5.4Other Identifiers
    Name:ShorTripNumber:ShorTrip
    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 SponsorFondazione GONO
    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 supportFondazione GONO
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione GONO
    B.5.2Functional name of contact pointSede operativa Pisa
    B.5.3 Address:
    B.5.3.1Street AddressVia Roma, 67
    B.5.3.2Town/ cityPisa
    B.5.3.3Post code56126
    B.5.3.4CountryItaly
    B.5.4Telephone number050992192
    B.5.5Fax number050992069
    B.5.6E-mailshortripstudy@gmail.com
    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.2.1.2Country 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 nameIrinotecan
    D.3.2Product code [Irinotecan]
    D.3.4Pharmaceutical form Concentrate and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracavernous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIRINOTECAN CLORIDRATO TRIIDRATO
    D.3.9.1CAS number 100286-90-6
    D.3.9.2Current sponsor codeIRINOTECAN
    D.3.9.3Other descriptive nameIrinotecan is a semi-synthetic derivative of camptothecin. It is an antineoplastic agent which acts as a specific inhibitor of DNA topoisomerase I.
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    TUMORE DEL RETTO LOCALMENTE AVANZATO
    E.1.1.1Medical condition in easily understood language
    Rectal cancer amenable to curative resection.
    Tumore del retto operabile
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10038050
    E.1.2Term Rectal cancer stage III
    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
    The primary objective of this trial is to evaluate the rate of complete pathologic response (pCR)
    L’obiettivo principale del protocollo è di valutare il tasso di risposte complete patologiche (pCR), definito come la percentuale di pazienti, relativo al totale di soggetti arruolati, con assenza di cellule tumorali residue nel campione resecato.
    Il trattamento sperimentale proposto sarà considerato promettente se saranno osservate almeno 21 pCR su un totale di 63 pazienti arruolati.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are to evaluate:
    • Safety profile
    • R0 resection rate
    • Failure-free survival (FFS)
    • Overall survival (OS)
    • Distant relapse
    • Locoregional failure
    • Clinical complete response after neoadjuvant treatment
    • Major pathological response (MPR)
    • Post-operative morbidity and mortality
    • Quality of life (QoL)
    • Rectal Continence
    Obiettivi secondari di questo studio sono valutare:
    • Profilo di sicurezza
    • Tasso di resezione R0
    • Sopravvivenza libera dal fallimento (FFS)
    • Sopravvivenza complessiva (OS)
    • Recidiva a distanza
    • Recidiva loco-regionale
    • Tasso di risposta completa clinica dopo trattamento neoadiuvante
    • Tasso di risposta patologica maggiore (MPR)
    • Qualità della vita (QoL)
    • Continenza rettale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18-70 years;
    Histologically proven diagnosis of rectal adenocarcinoma;
    Patients with locally advanced rectal cancer defined by the presence of at least one of the following features:
    o cN2 (defined as at least 4 positive lymphnodes at pelvic MRI)
    o cT4
    o tumor extending to within 1 mm of or beyond mesorectal fascia (i.e., circumferential radial margin threatened or involved)
    o cT3, N1
    Distal border of the tumour located between 5 and 12 cm from the anal verge (as measured by pelvic MRI);
    Eastern Cooperative Oncology Group Performance Status (ECOG PS) =1;
    No evidence of metastatic disease by total body CT-scan;
    Tumour amenable to curative resection (including pelvic exenteration);
    No history of invasive rectal malignancy, regardless of disease-free interval;
    No other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma) or synchronous colon cancer;
    No clear involvement of the pelvic side walls by imaging.
    Età compresa tra 18 e 70 anni;
    Diagnosi istologica di adenocarcinoma del retto;
    Paziente con tumore del retto localmente avanzato definito come la presenza di almeno una delle seguenti caratteristiche:
    o cN2 (definito come almeno 4 linfonodi positivi alla RM pelvica)
    o cT4
    o tumore che si estende entro 1 mm o oltre la fascia mesorettale (es. margine radiale circinferenziale a rischio o coinvolto dal tumore)
    o cT3, N1
    Margine distale del tumore localizzato tra 5 e 12 cm dal margine anale (misurato alla RM pelvica);
    ECOG-PS =1;
    Non evidenza di malattia metastatica alla TC total-body;
    Tumore asportabile chirurgicamente (inclusa exenteratio pelvica);
    Nessuna storia pregressa di tumore del retto maligno, indipendente dall’intervallo libero da malattia;
    Nessun altro tumore rettale (es. sarcoma, linfoma, carcinoide, carcinoma a cellule squamose o carcinoma cloacogenico) o tumore sincrono del colon;
    Nessun chiaro coinvolgimento della parete pelvica alle immagini radiologiche.
    E.4Principal exclusion criteria
    Patients with radiological evidence of distant metastases;
    Previous pelvic radiation therapy;
    Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria;
    Previous treatment with fluoropyrimidine and/or oxaliplatin and/or irinotecan;
    Patient with complete dihydropyrimidine dehydrogenase (DPYD) deficiency (homozygous of the following DPYD polymorphisms: c1679GG, c1905+1AA, c2846TT);
    Partial or total colectomy;
    Known hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
    Pazienti con evidenza radiologica di metastasi a distanza;
    Precedente radioterapia pelvica;
    Neuropatia periferica sintomatica di grado > 2 secondo i criteri NCIC-CTG;
    Precedente trattamento con fluoropirimidina e/o oxaliplatino e/o irinotecano;
    Paziente con deficit completo di diidropirimidina deidrogenasi (DPYD) (omozigote dei seguenti polimorfismi DPYD: c1679GG, c1905 + 1AA, c2846TT);
    Colectomia parziale o totale;
    Ipersensibilità nota al fluorouracile, oxaliplatino o irinotecano.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is Pathologic Complete Response (pCR) Rate. pCR rate is defined as the percentage of patients, relative to the total of enrolled subjects, achieving complete histological regression with no available tumor cells yT0N0.
    Tasso di risposte patologiche complete (pCR), definito come la percentuale di pazienti, relativo al totale di soggetti arruolati, con assenza di cellule tumorali residue nel campione resecato. La pCR sarà valutata in base al grado di regressione tumorale di Dworak all’esame istopatologico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.5.2Secondary end point(s)
    Failure-free survival (FFS) is defined as the time from enrollment to one of the following events: non-radical surgery (non R0/R1) of the primary tumour, intrapelvic recurrence after R0/1 resection of the primary tumour, distant relapse, second primary tumour or death from any cause, whichever occurred first. The determination of disease progression will be based on investigator-reported measurements. Patients who are alive without having one of the above events at the end of the study will be censored at their last radiological assessment.; Overall Toxicity rate, defined as the percentage of patients, relative to the total of enrolled subjects, who receive radiotherapy and at least one cycle of chemotherapy, experiencing any adverse event, according the RTOGTC during SCRT, and according to National Cancer Institute Common Toxicity Criteria (version 5.0), during the consolidation chemotherapy.; G3-4 Toxicity rate, is defined as the percentage of patients, relative to the total of enrolled subjects, who receive radiotherapy and at least one cycle of chemotherapy, experiencing a specific adverse event of grade 3/4, according the RTOGTC during SCRT, and according to National Cancer Institute Common Toxicity Criteria (version 5.0), during the consolidation chemotherapy.; R0 Resection Rate is defined as the percentage of patients, relative to the total of enrolled subjects, undergoing R0 resection of primary tumour. R0 surgery is defined as microscopically margin-negative resection at the histopatological exam.; Overall Survival (OS) is defined as the time from enrolment to death from any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.; Quality of Life, assessed using the EORTC QLQ-C30, the EORTC QLQ-CR29 and the EuroQol EQ-5D questionnaires, and Rectal Continence, assessed using LARS and St. Mark Continence scores, will be evaluate at specific time-points (baseline, after radiotherapy and chemotherapy, after surgery and during follow-up) and will be assessed through descriptive summary statistics.
    Sopravvivenza libera dal fallimento (FFS), definita come il tempo dall’arruolamento ad uno dei seguenti eventi: chirurgia del tumore primitivo non radicale (non R0/R1), recidiva intrapelvica dopo resezione R0/R1 del tumore primitivo, recidiva a distanza, secondo tumore primitivo, morte per qualsiasi causa, qualsiasi accada prima. La determinazione della recidiva di malattia sarà basata sulle misure riportate dello sperimentatore. I pazienti che sono vivi senza avere nessuno degli eventi sopra citati al momento dell’analisi saranno censorizzati all’ultima valutazione radiologica.; Tasso di tossicità complessiva, definita come percentuale dei pazienti, relativi al totale dei pazienti che ricevono la radioterapia e almeno un ciclo di chemioterapia, in cui si verifica qualsiasi evento avverso in base ai criteri RTOGTC durante la radioterapia short-course e in base ai criteri NCICTC versione 5 durante la chemioterapia di consolidamento; Tasso di tossicità di grado 3-4, definita come percentuale dei pazienti, relativi al totale dei pazienti che ricevono la radioterapia e almeno un ciclo di chemioterapia, in cui si verifica un evento avverso di grado 3-4 in base ai criteri RTOGTC durante la radioterapia short-course e in base ai criteri NCICTC versione 5 durante la chemioterapia di consolidamento.; Tasso di resezioni R0, definito come la percentuale di pazienti, relativi al totale dei pazienti arruolati, sottoposti ad una resezione R0 del tumore primitivo. La chirurgia R0 è definita come resezione con margini di resezione microscopicamente negativi all’esame istopatologico.; Sopravvivenza complessiva, definita come il tempo tra l’arruolamento e la morte per qualsiasi causa. Per i pazienti ancora vivi al momento dell’analisi, l’OS sarà censorizzata all’ultima data in cui il paziente è noto essere vivo.; Qualità della vita (QoL), valutata usando i questionari dell’EORTC QLQ-C30, EORTC QLQ-CR29 e EuroQol EQ-5D, e la Continenza rettale, valutata usando gli score LARS e St. Mark’s Continence, saranno valutati in specifici momenti (basale, dopo radioterapia e chemioterapia, dopo chirurgia e durante il follow-up) e analizzati con una statistica sommaria descrittiva.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years; 7 months; 7 months; 6 mesi; 5 years; 1 year
    3 anni; 7 mesi; 7 mesi; 6 mesi; 5 anni; 1 anno
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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
    prospettico_singolo braccio_ in aperto
    prospective_open label_single arm
    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 trial1
    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 concerned17
    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
    DURATION UNTIL PRIMARY ENDPOINT EVALUATION: 30 months (estimated date March 2024)
    OVERALL TRIAL DURATION (INCLUDING FOLLOW-UP): 7 years (estimated date September 2028)
    Durata dello studio fino alla valutazione dell' endpoint primario 30 mesi (data stimata marzo 2024)
    Durata complessiva dello studio che include l'endopint della Sopravvivenza: 5 anni (data stimata del LVLS settembre 2028)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 43
    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 state63
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 63
    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)
    Follow-up every three months for two years after the surgery, then every 6 months until the fifth years.
    Follow-up ogni tre mesi per i primi 2 anni dopo la chirurgia, poi ogni 6 mesi fino a 5 anni.
    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 Decision2021-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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