Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2006-006088-22
    Trial protocol
    		 DE  
    Global end of trial date
    09 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2022
    First version publication date
    29 Jun 2022
    Other versions
    Summary report(s)
    		 Report

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Gastripec-I
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02158988
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité Berlin
    Sponsor organisation address
    Universitätsmedizin Berlin, Berlin, Germany,
    Public contact
    Beate Rau, Chirurgie, Charité Campus Virchow-Klinikum, 0049 (0)30450 622 214, beate.rau@charite.de
    Scientific contact
    Beate Rau, Chirurgie, Charité Campus Virchow-Klinikum, 0049 (0)30450 622 214, beate.rau@charite.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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
    Protection of trial subjects
    Patient safety is ensured on the one hand by the collection of the secondary endpoint "30-day complication rate after cytoductive surgery with or without HIPEC" and on the other hand by regular examinations during study therapy and at a maximum interval of 3 months in follow-up. The study therapy is continued for the individual patient in a dose-limited manner or, if necessary, discontinued if there is serious dose-limiting toxicity or remittent severe adverse events that can be attributed to the study treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 Treatment with cytoreductive surgery (ZRC) and hyperthermic intraperitoneal chemotherapy (HIPEC) expects a significant increase in survival time. The decision to use cytoductive surgery is based on the idea of maximum tumor load reduction, which brings with it an improved response to intraperitoneal chemotherapy as well as the reduced likelihood of passage disorder due to intra-abdominal tumor progression. In order to create the best possible conditions for this, all patients are chemotheraped preoperatively before the main procedure.
    Actual start date of recruitment
    04 Mar 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research, Safety
    Long term follow-up duration
    		 30 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 105
    Worldwide total number of subjects
    105
    EEA total number of subjects
    105
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    78
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients with gastric cancer incl. adenocarcinoma of the esophagogastreal junction and peritoneal carcinomatosis without any distant metastases with exception of Krukenberg tumors were recruited from March 2014 to June 2018

    Pre-assignment
    Screening details
    		 282 patients were screened Peritoneal staging and the possibility of reduction (80% of the tumour) in line with zytoreductive surgery was evaluated at screening.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 No HIPEC
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Epirubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients with negative or unknown HER-2 status received 50 mg/m2 i.v. (max. 100 mg), Day 1 In 3 cycles of chemotherapy (2-3 weeks after the end of the last cycle) before cytotorductive surgery and 3 cycles of postoperative systemic chemotherapy (2-3 weeks after the end of the last cycle) 4-12 weeks after surgery

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients with negative or unknown HER-2 status received 130 mg/m2 i.v. (max. 260 mg), Day 1 In 3 cycles of chemotherapy (2-3 weeks after the end of the last cycle) before cytotorductive surgery and 3 cycles of postoperative systemic chemotherapy (2-3 weeks after the end of the last cycle) 4-12 weeks after surgery

    Investigational medicinal product name
    Capecitabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients with negative or unknown HER-2 status received 625 mg/m2 p.o. (2x daily., max. 2500 mg total), Day 1-21 In 3 cycles of chemotherapy (2-3 weeks after the end of the last cycle) before cytotorductive surgery and 3 cycles of postoperative systemic chemotherapy (2-3 weeks after the end of the last cycle) 4-12 weeks after surgery

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients with POSITVE HER-2 status received 80 mg/m² i.v. Day 1 (max. 160 mg) In 3 cycles of chemotherapy (2-3 weeks after the end of the last cycle) before cytotorductive surgery and 3 cycles of postoperative systemic chemotherapy (2-3 weeks after the end of the last cycle) 4-12 weeks after surgery

    Investigational medicinal product name
    Capecitabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients with POSISIVE HER-2 status received 1000 mg/m2 p.o. (2x daily, max. 4000 mg total), Day 1-14 In 3 cycles of chemotherapy (2-3 weeks after the end of the last cycle) before cytotorductive surgery and 3 cycles of postoperative systemic chemotherapy (2-3 weeks after the end of the last cycle) 4-12 weeks after surgery

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients with POSITIVE HER-2 status received 8 mg/kg i.v. Day 1 (first cycle, from second cycle 6 mg/kg) In 3 cycles of chemotherapy (2-3 weeks after the end of the last cycle) before cytotorductive surgery and 3 cycles of postoperative systemic chemotherapy (2-3 weeks after the end of the last cycle) 4-12 weeks after surgery

    Arm title
    		 Arm B
    Arm description
    		 HIPEC
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mitomycin C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    15 mg/m2 (max. 30 mg, max. 5 L Perfusat) intraoperative

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    75 mg/m2 (max. 150 mg, max. 5 L Perfusat) intraoperative

    Number of subjects in period 1
    		Arm A Arm B
    Started
    53
    52
    Completed
    53
    52

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 No HIPEC

    Reporting group title
    Arm B
    Reporting group description
    		 HIPEC

    Reporting group values
    		 Arm A Arm B Total
    Number of subjects
    		 53 52 105
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 40 38 78
        From 65-84 years
    		 13 14 27
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        female
    		 24 23 47
        male
    		 29 29 58

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 No HIPEC

    Reporting group title
    Arm B
    Reporting group description
    		 HIPEC

    Primary: Primary end point

    		 Close Top of page
    End point title
    		 Primary end point [1]
    End point description
    End point type
    Primary
    End point timeframe
    Randomisation until last patient out
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: For a full description of the trial analyses, please see trial synopsis, uploaded together with the posting of this results report.
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    53
    52
    Units: whole
    22
    27
    No statistical analyses for this end point

    Secondary: 30-days complication rate

    		 Close Top of page
    End point title
    		 30-days complication rate
    End point description
    30-days complication rate after cytoreductive surgery with or withour HIPEC
    End point type
    Secondary
    End point timeframe
    30 days after cytoreductive surgery
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    53
    52
    Units: whole
    53
    52
    No statistical analyses for this end point

    Secondary: Time to progress

    		 Close Top of page
    End point title
    		 Time to progress
    End point description
    Time to verifiable progress of tumor
    End point type
    Secondary
    End point timeframe
    From randomisation to last patient out
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    53
    52
    Units: whole
    35
    36
    No statistical analyses for this end point

    Secondary: Time to metastases

    		 Close Top of page
    End point title
    		 Time to metastases
    End point description
    Time of appearance of elsewhere localised metastases
    End point type
    Secondary
    End point timeframe
    From randomisation to last patient out
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    51
    49
    Units: whole
    34
    31
    No statistical analyses for this end point

    Secondary: Quality of life

    		 Close Top of page
    End point title
    		 Quality of life
    End point description
    Quality of life
    End point type
    Secondary
    End point timeframe
    Before surgery, begin of 4th chemotherapy cycle, begin of 6th cheomtherapy cycle, Follow-up 3 months after end of therapy, Follow-up 6 months after end of therapy
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    53
    52
    Units: whole
    53
    52
    No statistical analyses for this end point

    Secondary: toxicity and adverse events

    		 Close Top of page
    End point title
    		 toxicity and adverse events
    End point description
    Frequency of toxicity and adverse events
    End point type
    Secondary
    End point timeframe
    From begin of treatment to last patient out
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    53
    52
    Units: whole
    38
    42
    No statistical analyses for this end point

    Secondary: surgical and therapeutic intervention

    		 Close Top of page
    End point title
    		 surgical and therapeutic intervention
    End point description
    Frequency of required surgical and therapeutic intervention
    End point type
    Secondary
    End point timeframe
    After cytoreductive surgery upto 2.5 years
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    22 [2]
    28 [3]
    Units: whole
    4
    5
    Notes
    [2] - Numbers given exclusively for patients with complete cyto reduction
    [3] - Numbers given exclusively for patients with complete cyto reduction
    No statistical analyses for this end point

    Secondary: hospitalization

    		 Close Top of page
    End point title
    		 hospitalization
    End point description
    Duration of total hospitalization
    End point type
    Secondary
    End point timeframe
    During 2.5 years after randomisation
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    53
    52
    Units: whole
    53
    51
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Start of treatment until last performed follow-Up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Please see the list of AEs related and not related to the IMP in the trial synopsis, uploaded together with the posting of this results report.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Aug 2013
    Change of coordinating investigator biobanking added Change in the composition of the DMC Change in selection criteria Change in tehrapy for HER-2 positive patients Some changes in definitions

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun Apr 28 10:25:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA