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    Summary
    EudraCT Number:2006-006088-22
    Sponsor's Protocol Code Number:Gastripec-I
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-02-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-006088-22
    A.3Full title of the trial
    Prospective multicenter phase III clinical trial using cytoreductive surgery with hyperthermic intraoperative chemotherapy (HIPEC)
    after preoperative chemotherapy in patients with peritoneal carcinomatosis of gastric cancer incl. adenocarcinoma of the esophagogastreal junction
    Prospektive multizentrische Phase III-Studie zur zytoreduktiven Chirurgie mit hyperthermer intraperitonealer Chemoperfusion nach präoperativer Chemotherapie beim Magenkarzinom inkl. AEG mit primärer peritonealer Metastasierung
    (Gastripec I)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective multicenter phase III clinical trial using cytoreductive surgery with hyperthermic intraoperative chemotherapy (HIPEC)
    after preoperative chemotherapy in patients with peritoneal carcinomatosis of gastric cancer incl. adenocarcinoma of the esophagogastreal junction
    Prospektive multizentrische Phase III-Studie zur zytoreduktiven Chirurgie mit hyperthermer intraperitonealer Chemoperfusion nach präoperativer Chemotherapie beim Magenkarzinom inkl. AEG mit primärer peritonealer Metastasierung
    (Gastripec I)
    A.3.2Name or abbreviated title of the trial where available
    Gastripec I
    A.4.1Sponsor's protocol code numberGastripec-I
    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 SponsorKlinik für Chirurgie, Charité Campus Virchow-Klinikum
    B.1.3.4CountryGermany
    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 supportDeutsche Krebshilfe
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChirurgie, Charité Campus Virchow-Klinikum
    B.5.2Functional name of contact pointBeate Rau
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number0049(0)30450 622 214
    B.5.5Fax number0049(0)30450 7 522 214
    B.5.6E-mailbeate.rau@charite.de
    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 nameEpirubicin
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNEPIRUBICIN
    D.3.9.1CAS number 56420452
    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 Yes
    D.3.11.13.1Other medicinal product typesemisynthetic product
    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.2.5The 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.3.4Pharmaceutical 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.3.8INN - Proposed INNOXALIPLATIN
    D.3.9.1CAS number 61825943
    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 Yes
    D.3.11.13.1Other medicinal product typesynthetic product
    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.2.5The 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 namecapecitabin
    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.3.8INN - Proposed INNCAPECITABINE
    D.3.9.1CAS number 154361-50-9
    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 Yes
    D.3.11.13.1Other medicinal product typesynthetic product
    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 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 nameCisplatin
    D.3.4Pharmaceutical form Powder for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCisplatin
    D.3.9.1CAS number 15663271
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    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 Yes
    D.3.11.13.1Other medicinal product typesynthetic product
    D.IMP: 5
    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 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 nameTrastuzumab
    D.3.4Pharmaceutical form Powder 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.3.8INN - Proposed INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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: 6
    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 AuthorisationGermany
    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 nameMitomycin
    D.3.4Pharmaceutical form Powder 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 INNMITOMYCIN
    D.3.9.1CAS number 50-07-7
    D.3.9.4EV Substance CodeSUB09006MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Peritoneal carcinomatosis of gastric cancer incl. adenocarcinoma of the esophagogastreal junction
    Peritoneal metastasiertes Magenkarzinom inkl. AEG
    E.1.1.1Medical condition in easily understood language
    Peritoneal carcinomatosis of gastric cancer incl. adenocarcinoma of the esophagogastreal junction
    Peritoneal metastasiertes Magenkarzinom inkl. AEG
    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 LLT
    E.1.2Classification code 10042080
    E.1.2Term Stomach cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042081
    E.1.2Term Stomach cancer in situ
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the efficacy of hyperthermic intraoperative chemotherapy (HIPEC) (extension of survival starting at randomisation) by combination of pre-and postoperative chemotherapy + cytoreductive surgery and HIPEC compared to pre-and postoperative chemotherapy + cytoreductive surgery without HIPEC

    Wirksamkeit der HIPEC (Verlängerung der Überlebenszeit ab Randomisation) durch die Kombination von prä- und postoperativer Chemotherapie + zytoreduktiver Chirurgie mit HIPEC im Vergleich zu prä- und postoperativer Chemotherapie + zytoreduktiver Chirurgie ohne HIPEC)
    E.2.2Secondary objectives of the trial
    Secondary objectives are the evaluation of:
    1. safety problems of HIPEC lasting for a short time (30-days complication rate)
    2. time to verifiable progress of tumour
    3. time to appearance of elsewhere localised metastases
    4. quality of life
    5. frequency of toxicity and adverse events
    6. frequency of required surgical and therapeutic intervention
    7. duration of hospitalisation
    1. kurzfristigen Sicherheitsprobleme der HIPEC (30-Tage-Komplikationsrate)
    2. Zeit bis zum nachweisbaren Tumorprogress
    3. Zeit bis zum Auftreten anderenorts lokalisierter Fernmetastasen
    4. Lebensqualität
    5. Häufigkeit von Toxizitäten und unerwünschten Ereignissen
    6. Häufigkeit chirurgisch notwendiger Sekundärinterventionen
    7. Dauer der Gesamthospitalisierung
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) patients with gastric cancer incl. adenocarcinoma of the esophagogastreal junction and peritoneal carcinomatosis without any distant metastases with exception of Krukenberger tumosr
    2) peritoneal staging via laparoscopy and assessment of peritoneal carcinomatosis index (PCI) with the possibility of reduction (80% of the tumour) in line with zytoreductive surgery
    3) age ≥ 18 and ≤ 75 years
    4) Karnofsky Index ≥ 70%
    5) written informed consent
    1. Patienten mit Magenkarzinom inkl. AEG und bioptisch gesicherter Peritonealkarzinose ohne weitere Fernmetastasen ausgenommen Krukenberger Tumore
    2. Peritoneales Staging mittels Laparoskopie (ggf. explorative Laparotomie) und Einschätzung des Peritonealen Karzinose Index (PCI) mit der Möglichkeit einer mindestens 80%igen Tumormassenreduktion im Rahmen einer zytoreduktiven Chirurgie.
    3. Alter ≥ 18 und ≤ 75 Jahre
    4. Karnofsky Index ≥ 70%
    5. Schriftliche Einwilligungserklärung nach ausführlicher Aufklärung
    E.4Principal exclusion criteria
    1.) distant metastases except peritoneal carcinomatosis and Krukenberg tumors
    2.) other malignoma except curatively treated cervix carcinoma and basal cell carcinoma of the skin
    3.) previous chemotherapy or radiotherapx for peritoneal carcinomatosis
    4.) Inflammation in need of treatment
    5.) NYHA > 2
    6.) Myocardial infarction
    7.) cardiac arrhythmia
    8.) high blood pressure, constant > 180/100
    9.) cardiac function EF < 55%
    10.) Limited heart function
    11.) Insufficient renal function
    12.) Insufficient liver function
    13.) vaccinations during the last 6 weeks
    14.) Active hepatitis B/C
    15.) Pregnancy / lactation
    16.) No effective contraception
    17.) Missing of capacity to contract
    18.) contraindication to the drugs which are used in the trial
    19.) Participation in another investigational drug trial
    20.) Persons institutionalised due to regulatory actions ore by court order.
    1. Andere als peritoneale Fermetastasen des Magenkarzinoms inkl. AEG ausgenommen Krukenberger Tumore
    2. Andere Malignome in der Vorgeschichte außer kurativ behandeltes Cervixkarzinom und Basaliom der Haut
    3. Vorausgegangene Chemotherapie oder Radiotherapie für das Magenkarzinom
    4. Floride behandlungsbedürftige Entzündungen / Infektionen
    5. Lungengerüstveränderungen mit NYHA-Klasse > 2
    6. Akuter Myokardinfarkt und abgelaufener Myokardinfarkt, der zur muskulären Herzinsuffizienz Grad III und IV geführt hat
    7. Rhythmusstörungen mit klinisch relevanten, gravierenden hämodynamischen Komplikationen (auch in der Vorgeschichte)
    8. Arterielle Hypertonie, definiert als RR konstant > 180/100
    9. Eingeschränkte Herzfunktion mit EF < 55%
    10. Unzureichende Knochenmarksfunktion zu Beginn der klinischen Prüfung, definiert als Thrombozytenanzahl < 150 GPT/L oder Neutrophile Granulozytenanzahl < 1,5 GPT/L
    11. Unzureichende Nierenfunktion zu Beginn der klinischen Prüfung, definiert als GFR < 60 ml/min (berechnet mit der Cockroft Formel)
    12. Unzureichende Leberfunktion zu Beginn der klinischen Prüfung, definiert als Bilirubin > 1,5facher Wert des oberen Normalwertes
    13. Aktive Impfungen innerhalb von 6 Wochen vor Studieneinschluss
    14. Aktive Hepatitis B / C
    15. Schwangerschaft / Stillzeit
    16. Keine hocheffektive Kontrazeption
    Fertile weibliche Patienten (< 2 Jahre nach der letzten Menstruation) ohne angemessene kontrazeptive Maßnahmen (Implantate, Injektionen, orale Kontrazeptiva, intrauterine devices – Spiralen, Kondome in Verbindung mit einer weiteren kontrazeptiven Maßnahme (z.B. spermizides Gel, zweite Barrieremethode, vasektomierter Partner) während der Teilnahme an der Studie
    17. Fehlende Geschäftsfähigkeit
    18. Gegenanzeigen gegen die einzusetzenden Medikamente
    19. Teilnahme an anderen interventionellen Therapiestudien
    20. Personen, die aufgrund behördlicher oder gerichtlicher Anordnung in einer Anstalt untergebracht sind
    E.5 End points
    E.5.1Primary end point(s)
    Time from randomisation to death
    Zeit von Randomisation bis zum Tod jeglicher Ursache
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    Studienende
    E.5.2Secondary end point(s)
    1. for a short time safety problems of HIPEC ( 30-days complication rate)
    2. Time to verifiable progress of tumour
    3. Time of appearance of elsewhere localised metastases
    4. Quality of life
    5. frequency of toxicity and adverse events
    6. frequency of required surgical and therapeutic intervention
    7. Duration of hospital stay
    1. 30-Tage-Komplikationsrate nach zytoreduktiver Chirurgie mit oder ohne HIPEC
    2. Zeit bis zum nachweisbaren Tumorprogress
    3. Zeit bis zum Auftreten weiterer Fernmetastasen
    4. Lebensqualität
    5. Häufigkeit von Toxizitäten und unerwünschten Ereignissen
    6. Häufigkeit chirurgisch notwendiger Sekundärinterventionen
    7. Dauer der Gesamthospitalisierung
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Studienende
    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) 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
    ohne HIPEC
    without HIPEC
    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 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 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
    Last visit of last subject
    letzte Visite des letzten Patienten
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state180
    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)
    At the end of the study participation patients will be treated by their physicians according to their needs
    Die Nachsorge der Patienten nach Beendigung der klinischen Prüfung liegt in der Verantwortung des behandelnden Arztes.
    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 Decision2011-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
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