E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gastric cancer with peritoneal carcinomatosis or tumour positive cytology |
Maagkanker met peritoneale metastasen of tumorpositieve peritoneale cytologie |
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E.1.1.1 | Medical condition in easily understood language |
Gastric cancer with peritoneal metastasis or tumour cells in the abdominal fluid |
Maagkanker met buikvliesmetastasen of kankercellen in het buikvocht |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10017812 |
E.1.2 | Term | Gastric neoplasms malignant |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057647 |
E.1.2 | Term | Cytoreductive surgery |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061269 |
E.1.2 | Term | Malignant peritoneal neoplasm |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061965 |
E.1.2 | Term | Gastrectomy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067093 |
E.1.2 | Term | Intraperitoneal hyperthermic chemotherapy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052171 |
E.1.2 | Term | Peritoneal carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. systemic palliative chemotherapy. |
Doel van de studie is om te bepalen of een operatie bestaande uit een maagresectie, cytoreductie en HIPEC bij maagkanker patiënten met beperkte peritonitis carcinomatosa en/of tumor positieve peritoneale cytologie de overleving verbetert in vergelijking met de huidige standaard behandeling (palliatieve systemische chemotherapie). |
|
E.2.2 | Secondary objectives of the trial |
- To compare the progression free survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy. - To study treatment-related toxicity in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC. - To compare the costs and health benefits of a gastrectomy in combination with cytoreductive surgery and HIPEC, to the costs and health benefits of standard palliative systemic chemotherapy in patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology. - To identify genetic profiles related to tumour response in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology. (Optional) |
- Het vergelijken van progressie-vrije overleving tussen maagkanker patiënten met beperkte peritonitis carcinomatosa en/of tumor positieve peritoneale cytologie behandeld met een maagresectie, cytoreductieve chirurgie en HIPEC en degenen behandeld met de huidige standaard behandeling, namelijk, palliatieve systemische chemotherapie. - Het bestuderen van de toxiciteit na een behandeling met maagresectie, cytoreductieve chirurgie en HIPEC. - Het vergelijken van behandelkosten en gezondheidswinst tussen maagkanker patiënten met beperkte peritonitis carcinomatosa en/of tumor positieve peritoneale cytologie behandeld met een maagresectie, cytoreductieve chirurgie en HIPEC en degenen behandeld met de huidige standaard behandeling, namelijk, palliatieve systemische chemotherapie. - Het identificeren van genetische profielen die gerelateerd zijn aan tumorrespons |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥ 18 years - cT3-cT4 adenocarcinoma of the stomach, considered to be resectable - Limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology (proven by laparoscopy or laparotomy) - Absence of disease progression during prior systemic treatment |
- Leeftijd > 18 jaar - Potentieel resectabel cT3-cT4 adenocarcinoom van de maag - Beperkte peritonitis carcinomatosa en/of tumor positieve peritoneale cytologie (vastgelegd d.m.v. een laparoscopie of laparotomie) - Geen ziekteprogressie tijdens systemische chemotherapie (gegeven voorafgaand aan inclusie) |
|
E.4 | Principal exclusion criteria |
- Distant metastases or small bowel dissemination - Recurrent gastric cancer - Prior resection of the primary gastric tumour - Non-synchronous peritoneal carcinomatosis - Current other malignancy (other than cervix carcinoma and basalioma) - WHO performance status 3-4 - Inadequate bone marrow, hepatic and renal function - Hepatitis B or C, known HIV infection or an uncontrolled infectious disease - Recent myocardial infarction (< 6 months) or unstable angina - Uncontrolled diabetes mellitus - Pregnancy or breast feeding - Any medical condition that is considered to interfere with study procedures and/or would jeopardize safe treatment - Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents |
- Afstandsmetastasen of peritoneale metastasering op de dunne darm - Recidief maagcarcinoom - Eerdere resectie van het primaire maagcarcinoom - Niet-synchrone peritonitis carcinomatosa - Aanwezigheid van een andere maligniteit (behalve cervixcarcinoom of basaalcelcarcinoom) - WHO performance status 3-4 - Onvoldoende beenmerg-, lever- of nierfunctie - Hepatitis B of C, HIV-infectie of een ongecontroleerde infectie ziekte - Recent myocard infarct (< 6 maanden) of instabiele angina pectoris - Ongecontroleerde diabetes mellitus - Zwangerschap en/of het geven van borstvoeding - Iedere medische aandoening waarvan te verwachten is dat deze interfereert met de studieprocedures of een veilig behandeltraject - Bekende overgevoeligheid voor één van de gebruikte chemotherapeutica en/of oplosmiddelen |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall survival |
Overleving |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Overall survival will be calculated when 80 deaths are observed. |
De overleving wordt berekend na het overlijden van 80 patiënten. |
|
E.5.2 | Secondary end point(s) |
- Progression free survival - Treatment-related toxicity - Costs and resource use - Quality of life, utilities - Genetic profiles related to tumour response (optional) |
- Progressie-vrije overleving - Aan de behandeling gerelateerde toxiciteit - Kosten van de behandeling en de benodigdheden - Kwaliteit van leven - Genetische profielen gerelateerd aan de tumorrespons (optie) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |