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KURZPROTOKOLL AIO-STO-0110 Öffentlicher Titel Catumaxomab für die Behandlung von Peritonealkarzinose bei Patienten mit MagenAdenokarzinomen Wissenschaftl. Titel Explorative Trial to Investigate Catumaxomab (Anti-EpCAM x Anti-CD3) for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas Prior to Gastrectomy Kurztitel AIO-STO-0110 Studienart multizentrisch, prospektiv, randomisiert, offen/unverblindet, Pharma-Studie, zweiarmig Studienphase Phase II Erkrankung GASTRO: Magen-/Ösophaguskarzinom: Neoadjuvant Ziele - Rate of macroscopic complete remissions of peritoneal carcinomatosis - Macroscopic complete response (mCR) rate of the peritoneal lesions, as resulting from the second diagnostic laparoscopy or laparotomy performed after chemotherapy. - Surgical resection rate (R0, R1, R2) - All tumor evaluation is performed according to RECIST Overall survival (OS) - The duration of overall survival (OS) will be determined by measuring the time interval from randomization to the date of death or last observation (censored). - Disease-free survival (DFS) - Disease-free survival (DFS) will be defined as the time from surgery, resulting in a R0 finding and macroscopic complete remission of PC, to the time of disease progression or relapse (according to RECIST) or death, or to the date of last assessment without any such event (censored observation). - Patients with evidence of disease at surgery are counted as having the event at time = 0. Progression-free survival (PFS) - Progression-free survival (PFS) will be defined as the time from randomization to the time of disease progression or relapse (according to RECIST) or death, or to the date of last assessment without any such event (censored observation). - Frequency, relationship, and severity of AEs - Immunoreaction against tumor in tissue samples blood and tumor tissue from every patient assed at 2time points. the first Laparoscopy (before randomization)and the second Laparoscopy (after chemotherapy) - Detection of disseminated tumor cells via PCR blood and tumor tissue from every patient assessed at 2time points. - The first Laparoscopy (before randomization) and the second Laparoscopy (after chemotherapy) - - Histologically confirmed diagnosis of resectable gastric adenocarcinoma or adenocarcinoma of the esophagogastric junction (type II and type III according to Siewerts classification) - Macroscopic peritoneal carcinomatosis (stage P1-4 according to Gilly et al., appendix 1) - Patients potentially eligible for gastrectomy after primary systemic (and intraperitoneal) treatment - Signed and dated informed consent before the start of specific protocol procedures - Age > 18 years - ECOG Performance Status of 0 or 1 - Life expectancy of at least 12 weeks - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening Einschlusskriterien © Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de Stand: 16.01.2017; Seite 1 von 3 KURZPROTOKOLL AIO-STO-0110 Ausschlusskriterien - a. Hemoglobin > 10.0 g/dl - b. Leukocyte count > 4.000/l; - c. absolute neutrophil count (ANC) > 2.000/l - d. Platelet count > = 100.000/µl - e. Total bilirubin < 1,5 times the upper limit of normal - f. ALT and AST < 3 x upper limit of normal - g. Alkaline phosphatase < 5 x ULN - h. Serum creatinine < 1.5 x upper limit of normal - i. creatinine clearance > 60 ml/min - The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations - Distant metastasis other than peritoneal seedings - Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry - Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = < 1 year before enrolment - History of HIV infection or chronic hepatitis B or C - Active, clinically serious infections (> grade 2 NCI-CTC version 3.0) - Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex - Patients with seizure disorder requiring medication (such as steroids or antiepileptics) - History of organ allograft Patients undergoing renal dialysis - Known hypersensitivity to any of the drugs given in the study; known hypersensitivity to murine (rat and/or mouse) proteins - Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study - Excluded therapies and medications, previous and concomitant: Prior anti-cancer chemotherapy or immunotherapy - Investigational drug therapy outside of this trial during or within 4 weeks of study entry - Major surgery within 4 weeks of starting the study, and patients must have recovered from effects of major surgery - Pregnant or breast-feeding patients, or planning to become pregnant within 6 months after the end of treatment. - Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. - Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and for 6 months after the end of treatment - Substance abuse, medical, psychological or social conditions that may interfere with the patient's understanding of the informed consent procedure, participation in the study or evaluation of the study results Alter 18 Jahre und älter Status Geschlossen Beginn der Rekrutierung 01.08.2011 © Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de Stand: 16.01.2017; Seite 2 von 3 KURZPROTOKOLL AIO-STO-0110 Prüfzentren Krankenhaus Nordwest GmbH Institut für klinisch-onkologische Forschung Steinbacher Hohl 2-26 60488 Frankfurt am Main Prof. Dr. med. Salah-Eddin Al-Batran Tel: 069 7601 4420 [email protected] Weitere Ansprechpartner Leiter der klinischen Prüfung Universitätsklinikum Leipzig Prof. Dr. med. Florian Lordick Liebigstraße 18 04103 Leipzig [email protected] Registrierung in anderen Studienregistern ClinicalTrials NCT0150425 (primäres Register) EUDRACT 2010-024111-13 Therapie catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel © Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de Stand: 16.01.2017; Seite 3 von 3
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