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    Summary
    EudraCT Number:2017-000927-29
    Sponsor's Protocol Code Number:NL60405.100.17
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-12
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-000927-29
    A.3Full title of the trial
    Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a multicentre, open-label, single-arm, phase II study (CRC-PIPAC)
    Repetitieve electrostatische 'pressurised intraperitoneal aerosol chemotherapy' met oxaliplatine (ePIPAC-OX) als een palliatieve monotherapie voor geïsoleerde irresectabele colorectale peritoneale metastasen: protocol van een multicenter, open-label, enkelarmige, fase II studie (CRC-PIPAC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PIPAC for peritoneal metastases of large bowel cancer
    PIPAC voor buikvliesuitzaaiingen uit dikkedarmkanker
    A.3.2Name or abbreviated title of the trial where available
    CRC-PIPAC
    CRC-PIPAC
    A.4.1Sponsor's protocol code numberNL60405.100.17
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN89947480
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03246321
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1200-0765
    A.5.4Other Identifiers
    Name:Netherlands Trial RegistryNumber:NTR6603
    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 SponsorCatharina Ziekenhuis
    B.1.3.4CountryNetherlands
    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 supportCapnoMed
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportAlesi Surgical
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCatharina Ziekenhuis
    B.5.2Functional name of contact pointKoen Rovers
    B.5.3 Address:
    B.5.3.1Street AddressMichelangelolaan 2
    B.5.3.2Town/ cityEindhoven
    B.5.3.3Post code5623 EJ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031402396351
    B.5.6E-mailkoen.rovers@catharinaziekenhuis.nl
    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 Oxaliplatin Accord
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare 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.3.1Product nameOxaliplatin
    D.3.2Product code L01XA03
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    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.IMP: 2
    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 Fluorouracil Accord
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare 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.3.1Product name5-fluorouracil
    D.3.2Product code L01BC02
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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.IMP: 3
    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 Rescuvolin
    D.2.1.1.2Name of the Marketing Authorisation holderPharmachemie B.V.
    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.3.1Product nameLeucovorin
    D.3.2Product code V03AF03
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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
    Isolated unresectable colorectal peritoneal metastases
    Geïsoleerde irresectabele colorectale peritoneale metastasen
    E.1.1.1Medical condition in easily understood language
    Inoperable peritoneal metastases of large bowel cancer
    Inoperabele peritoneale metastasen uit dikkedarmkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the safety of repetitive ePIPAC-OX as a palliative monotherapy for patients with isolated unresectable colorectal peritoneal metastases (PM).
    Exploreren van de veiligheid van repetitieve ePIPAC-OX als palliatieve monotherapie voor patiënten met geïsoleerde irresectabele colorectale PM.
    E.2.2Secondary objectives of the trial
    To explore the feasibility, tolerability, preliminary efficacy, costs, and pharmacokinetics of repetitive ePIPAC-OX as a palliative monotherapy for patients with isolated unresectable colorectal PM.
    Exploreren van de haalbaarheid, tolerabiliteit, effectiviteit, kosten, en farmacokinetiek van repetitieve ePIPAC-OX als palliatieve monotherapie voor patiënten met geïsoleerde irresectabele colorectale PM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible patients are adults who have:
     a World Health Organisation (WHO) performance status of ≤1 and life expectancy >3 months;
     histological or cytological proof of PM of a colorectal or appendiceal carcinoma;
     unresectable disease determined by abdominal computed tomography (CT) and a diagnos-tic laparoscopy or laparotomy; .
     adequate organ functions (haemoglobin ≥5.0 mmol/L, neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L, serum creatinine <1.5 x ULN, creatinine clearance ≥30 ml/min, and liver trans-aminsases <5 x ULN);
     no symptoms of gastrointestinal obstruction;
     no radiological evidence of systemic metastases;
     no contraindications for oxaliplatin or 5-fluorouracil/leucovorin;
     no contraindications for a laparoscopy;  no previous PIPAC-procedures;
     written informed consent.

    Importantly, enrolment is allowed for patients with an unresected primary tumour (if asymptomatic) and for patients in various lines of palliative treatment, including patients who refuse, have not had, or do not qualify for first-line palliative systemic therapy. All potentially eligible patients are discussed in a multidisplinary team. Enrolled patients need to be informed about the potential consequences of postponing or discontinuing standard palliative treatment by a medical oncologist prior to enrolment.
    Geschikte patiënten zijn volwassenen met:
     een WHO performance score van ≤1 en een levensverwachting van >3 maanden;
     histologisch of cytologisch bevestigde PM van een colorectaal- of appendixcarcinoom;
     irresectabele ziekte bepaald door een abdominale CT-scan en een diagnostische laparoscopie/laparotomie;
     adequate orgaanfuncties (hb ≥5.0 mmol/L, neutrofielen ≥1.5 x 109/L, plaatjes ≥100 x 109/L, serumkreatinine <1.5 x ULN, kreatinineklaring ≥30 ml/min, en levertransaminases <5 x ULN);  geen symptomen van gastro-intestinale obstructie;
     geen radiologsich bewijs voor systemische metastasen;
     geen contraindicaties voor oxaliplatine of 5-fluorouracil/leucovorine;
     geen contraindicaties voor een laparoscopie;
     geen eerdere PIPAC-procedures;
     ondertekend informed consent.

    Inclusie is toegestaan voor patiënten met een niet-gereseceerde primaire tumor (als asymptomatisch) en voor patiënten in verschillende palliatieve behandellijnen, inclusief patiënten die eerstelijns palliatieve systemische therapie weigeren, niet hebben gehad, of daar niet voor in aanmerking komen. Alle potentieel geschikte patiënten worden besproken in een MDO. Geïncludeerde patiënten moeten geïnformeerd worden over de potentiele consequenties van het uitstellen of discontinueren van hun standaard palliatieve behandeling door een medisch oncoloog voor inclusie.
    E.4Principal exclusion criteria
    See inclusion criteria
    Zie inclusiecriteria.
    E.5 End points
    E.5.1Primary end point(s)
    The number of patients with major toxicity (grade ≥3 according to the Common Terminology Criteria for Adverse Events v4.0) up to four weeks after the last procedure.
    Het aantal patiënten met ernstige toxiciteit (graad ≥3 volgens CTCAE v4.0) tot 4 weken na de laatste PIPAC-procedure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    See E.5.1.
    Zie E.5.1.
    E.5.2Secondary end point(s)
    Secondary outcomes are:
     the environmental safety of ePIPAC-OX, based on air concentrations and surface concentrations of oxaliplatin during the first three procedures, measured by atomic absorption spectrophotometry;
     procedure-related characteristics of ePIPAC-OX (e.g. laparoscopic access, intraoperative complications, amount of adhesions, technical difficulties, operating time);
     the number of procedures in each patient and reasons for discontinuation;
     minor toxicity, defined as grade ≤2 according to CTCAE v4.0, up to four weeks after the last ePIPAC-OX;
     organ-specific toxicity, based on bone marrow, liver, and kidney functions measured at dif-ferent time points (Table 1 in protocol);
     major and minor postoperative complications, defined as grade ≥3 and grade ≤2 according to Clavien-Dindo, respectively, up to four weeks after the last ePIPAC-OX;
     hospital stay, defined as the number of days between ePIPAC-OX and initial discharge;
     readmissions, defined as any hospital admission after initial discharge, up to four weeks af-ter the last ePIPAC-OX;
     radiological tumour response, based on central review of thoracoabdominal CT and DW-MRI at baseline and four weeks after each ePIPAC-OX, performed by two independent ra-diologists blinded to clinical outcomes (classification is not defined a priori);
     histopathological tumour response, based on central review of collected peritoneal biop-sies during each ePIPAC-OX, performed by two independent pathologists blind-ed to clinical outcomes by using the Peritoneal Regression Grading Score;
     cytological tumour response, based on collected ascites or peritoneal washing cytology dur-ing each ePIPAC-OX;
     macroscopic tumour response, based on PCI and ascites volume during each ePIPAC-OX;
     biochemical tumour response, based on tumour markers measured at different time points (Table 1 in protocol);
     quality of life, extracted from questionnaires (EQ-5D-5L, QLQ-C30, QLQ-CR29) at different time points (Table 1 in protocol);
     costs, derived from the Dutch costing guidelines for health care research at the time of analysis, based on case report forms, hospital information systems, and questionnaires (iMTA PCQ, iMTA MCQ) at different time points (Table 1 in protocol);
     progression-free survival, defined as the time between enrolment and clinical, radiological, or macroscopic progression, or death;
     overall survival, defined as the time between enrolment and death.
    Secundaire uitkomstmaten zijn:
     de omgevingsveiligheid van ePIPAC-OX, gebaseerd op luchtconcentratie en oppervlakteconcentraties van oxaliplatin tijdens de eerste drie procedures, gemeten met atomaire absorptiespectrometrie;
     procedure-gerelateerde karakteristieken van ePIPAC-OX (bv laparoscopische access, intraoperatieve complicaties, adhesies, technische problemen, operatieduur, etc);
     het aantal procedures per patiënt en redenen voor stoppen ePIPAC-OX;
     mineure toxiciteit, gedefinieerd als graad ≤2 volgens CTCAE v4.0, tot 4 weken na de laatste ePIPAC-OX;
     orgaanspecifieke toxiciteit, gebaseerd op beenmerg-, lever-, en nierfunctie gemeten op verschillende tijdsmomenten (Tabel 1 in protocol);
     majeure en mineure postoperatieve complicaties, gedefinieerd als graad ≥3 en graad ≤2 volgens Clavien-Dindo, respectievelijk, tot 4 weken na de laatste ePIPAC-OX;
     opnameduur, gedefinieerd als het aantal patiënten tussen ePIPAC-OX en initieel ontslag;
     heropnames, gedefinieerd als elke ziekenhuisopname na initieel ontslag, tot 4 weken na de laatste ePIPAC-OX;
     radiologische tumorrespons, gebaseerd op centrale review van thoracoabdominale CT-scans en DW-MRI op baseline en 4 weken na iedere ePIPAC-OX, door twee onafhankelijk radiologen geblindeerd voor klinische uitkomsten (classificatie niet vooraf gedefinieerd)
     histologische tumorrespons, gebaseerd op centrale review van verzamelde biopten tijdens ePIPAC-OX, door twee onafhankelijk pathologen geblindeerd voor klinische uitkomsten (classificatie: PRGS);
     cytologische tumorrespons, gebaseerd op ascites (of peritoneaal spoelvocht) tijdens iedere ePIPAC-OX;
     macroscopische tumorrespons, gebaseerd op PCI en ascitesvolume tijdens iedere ePIPAC-OX;
     bioschemische tumorrespons, gebaseerd op tumormarkers gemeten op verschillende tijdsmomenten (Tabel 1 in protocol);
     kwaliteit van leven, geextraheerd uit vragenlijsten (EQ-5D-5L, QLQ-C30, QLQ-CR29) op verschillende tijdsmomenten (Tabel 1 in protocol);
     kosten, gebaseerd op de Nederlandse kostenrichtlijn voor de gezondheidszorg ten tijde van de analyse, geextraheerd uit CRF's, ziekenhuissystemen, en vragenlijsten (iiMTA PCQ, iMTA MCQ) op verschillende tijdsmomenten (Tabel 1 in protocol);
     progressievrije overleving, gedefinieerd als de tijd van inclusie tot klinische, radiologische, en macroscopische progressie of overlijden;
     algehele overleving, gedefineerd als de tijd van inclusie tot overlijden.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2.
    Zie E.5.2.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    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 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    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: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with end stage disease in a palliative setting
    Patiënten met eind-stadium-ziekte in een palliatieve setting
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    Regular oncological follow-up according to local protocol
    Reguliere oncologische follow-up volgens lokaal protocol.
    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 Decision2017-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-31
    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
    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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