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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   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:2020-001419-25
    Sponsor's Protocol Code Number:GastricCHIMERAtrial
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-01-05
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-001419-25
    A.3Full title of the trial
    Preoperative intraperitoneal chemotherapy in adjuvant hyperthermia
    adjunctive therapy in advanced gastric cancer with high-risk of peritoneal recurrence - a multicentre randomized trial
    Przedoperacyjna chemioterapia dootrzewnowa w hipertermii uzupełniająca leczenie skojarzone w zaawansowanym raku żołądka z wysokim ryzykiem nawrotu otrzewnowego - badanie wieloośrodkowe z randomizacją
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preoperative intraperitoneal chemotherapy in adjuvant hyperthermia
    adjunctive therapy in advanced gastric cancer with high-risk of peritoneal recurrence - a multicentre randomized trial
    Przedoperacyjna chemioterapia dootrzewnowa w hipertermii uzupełniająca
    leczenie skojarzone w zaawansowanym raku żołądka z wysokim ryzykiem
    nawrotu otrzewnowego - badanie wieloośrodkowe z randomizacją
    A.3.2Name or abbreviated title of the trial where available
    GastricCHIMERAtrial
    A.4.1Sponsor's protocol code numberGastricCHIMERAtrial
    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 SponsorJagiellonian University Medical College
    B.1.3.4CountryPoland
    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 supportMedicinal Research Agency
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJagiellonian University Medical College
    B.5.2Functional name of contact pointClinical Trial Office
    B.5.3 Address:
    B.5.3.1Street AddressPodwale 3
    B.5.3.2Town/ cityKraków
    B.5.3.3Post code31-118
    B.5.3.4CountryPoland
    B.5.4Telephone number+4812370 43 30
    B.5.5Fax number+4812422 49 18
    B.5.6E-mailbadania.kliniczne@uj.edu.pl
    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.2.5The 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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIRINOTECAN
    D.3.9.1CAS number 97682-44-5
    D.3.9.4EV Substance CodeSUB08295MIG
    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 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
    Gastric Carcinoma
    Rak żołądka
    E.1.1.1Medical condition in easily understood language
    Gastric Cancer
    Rak żołądka
    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 LLT
    E.1.2Classification code 10007350
    E.1.2Term Carcinoma gastric
    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
    To evaluate the effectiveness of perioperative FLOT4 chemotherapy in combination with preoperative intraperitoneal chemotherapy for hyperthermia (HIPEC) in patients with advanced gastric cancer at high risk of metastases to the peritoneal cavity - the main aim of the study is to reduce the frequency of peritoneal recurrences 6 months after gastrectomy compared to the group of patients treated without HIPEC.
    Ocena skuteczności okołooperacyjnej chemioterapii FLOT4 w połączeniu z przedoperacyjną chemioterapią dootrzewnową w hipertermii (HIPEC) u chorych z zaawansowanym rakiem żołądka z dużym ryzykiem wystąpienia przerzutów do jamy otrzewnej – celem głównym badania jest zmniejszenie częstości wznów otrzewnowych po 6 miesiącach od resekcji żołądka w porównaniu z grupą chorych leczonych bez HIPEC.
    E.2.2Secondary objectives of the trial
    1. Improvement in overall survival over the period of 6 months, 1 year, 3 and 5 years - counted from the date of gastric resection
    2. Improvement in disease-free survival over the period of 6 months, 1, 3 and 5 years - counted from the day on which the gastric resection was performed
    3. Reduction in relapse rates over 6 months, 1, 3 and 5 years
    4. Assessment of the incidence of postoperative complications on the Clavien-Dindo scale
    1. Poprawa przeżycia całkowitego w okresie 6 miesięcy, 1 roku, 3 i 5 lat – liczone od dnia, w którym wykonano resekcję żołądka
    2. Poprawa przeżycia wolnego od choroby w okresie 6 miesięcy, 1, 3 i 5 lat – liczone od dnia, w którym wykonano resekcję żołądka
    3. Zmniejszenie odsetka wznów w okresie 6 miesięcy, 1, 3 i 5 lat
    4. Ocena częstości powikłań pooperacyjnych w skali Clavien-Dindo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - gastric cancer confirmed in histological examination of material taken during gastroscopy and biopsy of the tumour
    - advanced gastric cancer (cT3/T4a, cN0-3b)
    - no distant metastases on chest, abdominal and pelvic computed tomography (cM0)
    - age 18-75
    - signed written informed consent
    -completion of at least 3 cycles of preoperative FLOT chemotherapy
    1. Rak żołądka potwierdzony histopatologicznie w wycinkach pobranych z guza podczas gastroskopii, posiadanie przez pacjenta aktualnego badania gastroskopowego konieczne jest do oceny kryteriów włączenia.
    2. Zaawansowanie raka żołądka cT3/cT4a/N0-3b, na podstawie badania CT dostarczonego przez pacjenta.
    3. Brak przerzutów odległych w badaniu CT klatki piersiowej, jamy brzusznej i miednicy (cM0)
    4. Wiek 18-75 lat
    5. Podpisanie świadomej zgody na udział w badaniu
    6. Ukończenie co najmniej 3 cykli przedoperacyjnej chemioterapii FLOT
    E.4Principal exclusion criteria
    - lack of confirmation of gastric cancer in histologic examination of biopsy material taken during gastroscopy
    - age > 75
    - Performance status 3 or higher in ECOG/WHO scale
    - previous abdominal surgery other than appendectomy or laparoscopic cholecystectomy
    - pregnancy or lactation
    - lack of written informed consent
    - other simultaneous neoplasm
    - previous systemic treatment or radiotherapy for other neoplasm
    - serious dysfagia requiring surgical treatment before previous chemotherapy
    - lack of qualification to perioperative chemotherapy by multidisciplinary team (MDT)
    1. Brak jednoznacznego potwierdzenia histopatologicznego raka żołądka
    2. Wiek > 75 lat lub wiek< 18 lat
    3. Zły stan ogólny (Performance Status 3 lub większy w skali ECOG/WHO)
    4. Przebyte zabiegi operacyjne w zakresie jamy brzusznej inne niż wycięcie wyrostka robaczkowego, pęcherzyka żółciowego, macicy i/lub przydatków, w tym zabiegi z zakresu chirurgii onkologicznej
    5. Obecność przerzutów odległych
    6. Ciąża i laktacja, u kobiet w wieku rozrodczym beta hCG zostanie oznaczone przed każdym podaniem chemioterapii systemowej oraz przed hospitalizacją, podczas, której wykonana zostanie laparoskopia diagnostyczna
    7. Brak zgody na udział w badaniu
    8. Współistniejący nowotwór w innej lokalizacji
    9. Przebyte leczenie systemowe lub radioterapia z powodu innego nowotworu
    10. Wskazania do przyspieszonej operacji z powodu dysfagii lub z innych przyczyn
    11. Pacjent nieobjęty ubezpieczeniem zdrowotnym na terenie RP
    E.5 End points
    E.5.1Primary end point(s)
    Peritoneal recurrence rate
    Częstość występowania wznów otrzewnowych
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 6 months - measured from the day of gastrectomy
    6 miesięcy po resekcji żołądka
    E.5.2Secondary end point(s)
    1. Overall survival
    2. Disease free survival
    3. Recurrence rates
    4. Postoperative complications rates according to Clavien-Dindo classification
    5. Quality of life assessment by means of QLQ-C30 and STO22 questionaries
    1. Przeżycie całkowite oraz przeżycie wolne od choroby;
    2. Odsetek wznów;
    3. Częstość powikłań pooperacyjnych w skali Clavien-Dindo;
    4. Ocena parametrów jakości życia przy użyciu kwestionariusza QLQ-C30 oraz STO22
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months, 1 year, 3 and 5 years - measured from the day of gastrectomy
    6 miesięcy, 1, 3 i 5 lat – liczone od dnia, w którym wykonano resekcję żołądka
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    terapia standardowa
    standard therapy
    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 concerned7
    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.1.1.1In 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state182
    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 standard treatment provided with personal insurance
    Standardowe leczenie zgodne z ubezpieczeniem
    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 Decision2021-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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