E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intraoperative Chemotherapy is used after a complete macroscopic removal of peritoneal metastases ( peritonectomy ) to kill tumor cells remaining free or minimal residual residual tumor . This allows an improved overall survival compared with a sole systemic chemotherapy can be achieved. |
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E.1.1.1 | Medical condition in easily understood language |
Intraoperative Chemotherapy after complete removal of peritoneal metastases to kill tumor cells remaining free or minimal residual tumor . |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
30 days mortality after macroscopically complete resection ( R0 / R1 ) of pancreatic adenocarcinoma in combination with HIPEC |
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E.2.2 | Secondary objectives of the trial |
Safety and side effect profile ( CTCAE 4.0 ) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
≥ 18 years • CT morphologically suspected pancreatic tumor without distant metastases , with the possibility of a macroscopically complete resection ( R0 / R1 ) . • Histological diagnosis of adenocarcinoma of the pancreas ' in the frozen section intraoperatively • Karnofsky Index > 70 |
≥ 18 Jahre • CT-morphologisch Verdacht auf Pankreastumor ohne Fernmetastasen mit der Möglichkeit einer makroskopisch vollständigen Resektion (R0/R1). • Histologische Diagnosesicherung eines Adenokarzinoms des Pankreas’ im Schnellschnitt intraoperativ • Karnofsky Index > 70
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E.4 | Principal exclusion criteria |
• Patients who are considered inoperable because of reduced general condition: - Congestive heart failure (NYHA III / IV) - Severe coronary heart disease, non-treatable arrhythmia or non-adjustable hypertension, - Severe asthma suffering (COPD) - Renal insufficiency (serum creatinine ≥ 1.5x of normal, or creatinine clearance <60 ml / min.). • patients where the intra-operative frozen section no adenocarcinoma of the pancreas can be demonstrated • Patients suffering from a second malignancy (within 5 years in the study of consent) except basal cell carcinoma and curative treated in-situ carcinoma of the cervix • distant metastases (M> 0) • Patients with a contraindication related to the present study • allergy or intolerance to the study drug or a substance with chemical similarity to the study medication. • Patients under legal custodianship (For Example for significant psychiatric disabilities, etc.) or incarcerated patients • Patients That can not understand the purpose of the study due to mental, intellectual or linguistic problem. • Participation in Clinical Trials or other observation period of competing trials. • Females during pregnancy and lactation • Females of childbearing potential (FCBP) That do not agree - To utilize two reliable forms of contraception or practice complete abstinence from Simultaneously heterosexual contact for at least 28 days before start of treatment and for at least 28 days after administration of study treatment - To abstain from breastfeeding during study participation and 6 months after study treatment. • Males That do not agree -to use a latex condom during any sexual contact with FCBP during participation in the study and for at least 28 days study Following treatment, even if he has undergone a successful vasectomy -to refrain from donating semen or sperm for at least 28 days after study treatment. |
• Patienten, die aufgrund eines reduzierten Allgemeinzustandes als inoperable eingestuft werden: - dekompensierte Herzinsuffizienz (NYHA III / IV), - schwere koronare Herzerkrankung, nicht-behandelbare Arhythmie oder nicht-einstellbarer Bluthochdruck, - schweres Asthmaleiden (COPD), - Niereninsuffizienz (Serum Kreatinin ≥ 1.5x des Normwertes, oder eine Kreatinin-Clearance < 60 ml/min.). • Patienten, bei denen im intraoperativen Schnellschnitt kein Adenokarzinom des Pankreas nachgewiesen werden kann • Patienten, die an einem Zweitmalignom leiden (innerhalb von 5 Jahren zur Einwilligung in die Studie) ausgenommen Basaliome und kurative behandelte in-situ Karzinome der Cervix • Fernmetastasen (M>0) • Patienten mit bestehender Kontraindikation bezogen auf die vorliegende Studie • Allergie oder Unverträglichkeit der Studienmedikation oder einer Substanz mit chemischer Ähnlichkeit zur Studienmedikation. • Patients under legal custodianship (for example for significant psychiatric disabilities etc.) or incarcerated patients • Patients that cannot understand the purpose of the study due to mental, intellectual or linguistic problems. • Participation in other clinical trials or observation period of competing trials. • Females during pregnancy and lactation • Females of childbearing potential (FCBP) that do not agree - to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before start of treatment and for at least 28 days after administration of study treatment - to abstain from breastfeeding during study participation and 6 months after study treatment. • Males that do not agree -to use a latex condom during any sexual contact with FCBP during participation in the study and for at least 28 days following study treatment, even if he has undergone a successful vasectomy -to refrain from donating semen or sperm for at least 28 days after study treatment.
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E.5 End points |
E.5.1 | Primary end point(s) |
30 days mortality after macroscopically complete resection ( R0 / R1 ) of pancreatic adenocarcinoma in combination with HIPEC |
30 Tage Mortalität nach makroskopisch vollständiger Resektion (R0/R1) eines Adenokarzinom des Pankreas in Kombination mit HIPEC |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 days after macroscopically complete resection |
30 Tage Mortalität nach makroskopisch vollständiger Resektion |
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E.5.2 | Secondary end point(s) |
Safety and side effect profile ( CTCAE 4.0 ) |
Sicherheit und Nebenwirkungsprofil (CTCAE 4.0) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 days after macroscopically complete resection |
30 Tage Mortalität nach makroskopisch vollständiger Resektion |
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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 | No |
E.6.4 | Safety | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Feasibility , Safety and Toxicity of intraperitoneal application of Gemicitabin as intraoperative hyperthermic chemotherapy ( HIPEC ) as additional therapy after complete surgical resection in patients with adenocarcinoma of the pancreas |
Feasibility, Safety und Toxicity einer intraperitonealen Anwendung von Gemicitabin als intraoperative hypertherme Chemotherapie (HIPEC) als zusätzliche Therapie nach vollständiger chirurgischer Resektion bei Patienten mit Adenokarzinom des Pankreas |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |