E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Peritoneal carcinomatosis of gastric origin |
Peritoneaal gemetastaseerd maagcarcinoom |
|
E.1.1.1 | Medical condition in easily understood language |
Peritoneal metastases of gastric cancer |
Patiënten met maagkanker en uitzaaiingen op het buikvlies |
|
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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017767 |
E.1.2 | Term | Gastric cancer stage IV with metastases |
E.1.2 | System Organ Class | 100000004864 |
|
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 |
To assess the safety and feasibility of HIPEC and CS in Western patients with peritoneal metastases of gastric cancer, in terms of morbidity and mortality. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objective is to determine the effect on survival and recurrence. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histologically proven adenocarcinoma of the stomach.
- Surgical resectable carcinoma (T1-4a, N1-3) (table 1)
- Clinical or pathological proven peritoneal metastases
- Peritoneal Cancer Index (PCI) ≤12
- European Clinical Oncology Group (ECOG) performance status 0,1 or 2
- Age ≥ 18
- Written informed consent |
- Histologisch bewezen adenocarcinoom van de maag
- Chirurgisch resectabele tumor(T1-4a, N1-3)
- Klinisch of pathologisch bewezen peritoneale metastasen
- Peritoneal Cancer Index (PCI) ≤12
- European Clinical Oncology Group (ECOG) performance status 0,1 of 2
- Leeftijd ≥ 18
- Informed consent |
|
E.4 | Principal exclusion criteria |
- Distant metastases other than peritoneal metastases
- Siewert type I gastro-esophageal junction tumor.
- Peritoneal carcinomatosis as a presentation of recurrent disease
- Pregnancy
- Contraindication to cisplatin (e.g. hypersensitivity, HIV infection and inadequate bone marrow, hepatic or renal function) |
- Afstandsmetastasen anders dan peritoneaal
- Siewert type I overgangstumor.
- Peritonitis carcinomatosa als recidief
- Zwangerschap
- Contraindicatie voor cisplatine (e.g. allergie, HIV infectie and beenmergdisfunctie, lever- of nierfalen) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome is the percentage of overall surgical complications grade 3 and higher as stated by the Common Terminology Criteria for Adverse Events. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After discharge of last patient |
|
E.5.2 | Secondary end point(s) |
Secondary outcomes are mortality, events related to HIPEC, operation related events and postoperative recovery, including quality of life, disease free and overall survival. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
5 years after surgery of the last patient |
|
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 | 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 | 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) | 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.8.3 |
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 | Yes |
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 | 8 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |