E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Reducing the risk of peritoneal carcinomatosis in patients with stomach cancer with following treatment: gastrectomy incl. HIPEC vs. gastrectomy excl. HIPEC |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10017758 |
E.1.2 | Term | Gastric cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068069 |
E.1.2 | Term | Peritoneal carcinomatosis |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
Reducing the risk of peritoneal carcinosis in patients with stomach cancer with following treatment: gastrectomy incl. HIPEC vs. gastrectomy excl. HIPEC |
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E.2.2 | Secondary objectives of the trial |
Overall survival
Time free of recurrence
complication rate
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. histologically confirmed Adenocarcinoma of the stomach: uT2, uT3, all N, M0
2. no previous cytostatic chemotherapy
3. Both genders (female and male patients)
4. Age > 18. Patients to be at an age where reproduction is possible have to practice reliable methods of contraceptions („Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals“ [CPMP/ICH/286/95 mod]) during the study until 3 month after study participating. Female subjects will only be included if they have negative pregnancy test during screening.
5. ECOG ≤ 2
6. No distant metastasis after CT in lung and abdomen, in clinical suspicion exclusion of bone metastasis with bone scintigraphy or MRI
7. Leucozytes > 3.000/µl
8. Thrombozytes > 100.000/µl
9. Serum creatinine ≤ 1.5x of standard value, or Creatinine-Clearance > 60 ml/min
10. Written informed consent obtained prior to study entry
11. Normal ejektion fraction in echocardiography prior to therapy
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E.4 | Principal exclusion criteria |
1. Distant metastasis, and any non-resectable stadium
2. Hypersensitivity, contraindications for 5-FU, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin oder Docetaxel (see SmPC)
3. Active Coronary Heart Disease, Cardiomyopathy or Heart failure (NYHA stadium III-IV)
4. malignant secondary disease < 5 years ago (exception: cervical In-situ-Carcinoma, adequate treated Basal cell carcinoma
5. any major internal secundary disease or acute infections
6. Polyneuropathy > NCI Grade II
7. severe hepatic disfunction (AST/ALT > 3,5xULN, AP > 6xULN, Bilirubin > 1,5xULN)
8. Inflammatory bowel disease
9. Participation in another clinical study
10. Pregnancy or lactation period
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E.5 End points |
E.5.1 | Primary end point(s) |
progression of peritoneal carcinomatosis after following treatment: gastrectomy incl. HIPEC vs. gastrectomy excl. HIPEC |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Laparoscopy 12 month after Gastrectomy |
|
E.5.2 | Secondary end point(s) |
Overall survival
Time free of recurrence
complication rate |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the routine 5-year-Follow-Up-Investigations |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
|
progression of peritoneal carcinomatosis or any other stomach cancer related event |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |