E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients affected by peritoneal carcinomatosis from colorectal cancer or
pseudomyxoma peritonei |
pazienti affetti da carcinosi peritoneale da ca del colon o carcinosi
peritoneale da neoplasia mucinosa del peritoneo |
|
E.1.1.1 | Medical condition in easily understood language |
patients affected by peritoneal carcinomatosis from colorectal cancer or
pseudomyxoma peritonei |
pazienti affetti da carcinosi peritoneale da ca del colon o carcinosi
peritoneale da neoplasia mucinosa del peritoneo |
|
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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037138 |
E.1.2 | Term | Pseudomyxoma peritonei |
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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052362 |
E.1.2 | Term | Metastatic colorectal cancer |
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 |
verify if high intra abdominal pressure during hyperthermic
intraperitoneal chemotherapy could enhance tissue diffusion of cisplatin
inside peritoneal residual neoplastic tissues |
valutare se l'aumento dell pressione intra-addominale udrante la
chemioipertermia intraperitoneale (HIPEC) può
- migliorare la penetrazione del cisplatino nei residui tumor |
|
E.2.2 | Secondary objectives of the trial |
evaluate whether high intra abdominal pressure during hipec could:
- elicit changes on pharmacokinetics of cisplatin;
- impact on short term surgical outcomes (morbidity, mortality, time to
resuming bowel function, in-hospital stay)
|
valutare se l'aumento della pressione intra-addominale durante la
HIPEC può:
- cambiare la farmacocinetica del cisplatino nel plasma ultrafiltrato e nel
perfusato;
- influenzare i risultati chirurgici immediati (morbi mortalità, tossicità
sistemica, tempo per la ricanalizzaziozione intestinale e tempo di
degenza postoperatoria). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histological diagnosis of primary peritoneal carcinomatosis from
colorectal origin orpseudomyxoma peritonei;
2. Patients submitted to complete cytoreduction with residual tumor
<2.5 mm;
3. Patients at the end of cytoreduction should present the laboratorial
and hemodynamic parameters set as followings: Mean arterial pressure > 65
mmHg, Heart rate: < 100 bpm, Central venous pressure > 4mmHg, Cardiac index >
2.2, SvcO2 > 72%, and haemoglobin > 8,0 gr/dl. |
Pazienti affetti da carcinosi peritoneale da carcinoma del colon-retto o
pseudomixoma peritonei, sottoposti a intervento di citoriduzione completa con residuo di malattia <2.5mm con le seguenti caratteristiche alla fine della fase chirurgica del trattamento: Pressione arteriosa media > 65 mmHg, frequenza cardiaca: < 100 bpm, pressione venosa centrale > 4mmHg, Indici cardiaco > 2.2, SvcO2 > 72%, and hemoglobina > 8,0 gr/dl. |
|
E.4 | Principal exclusion criteria |
age>75 years, patients that does not give informed consent |
età >75 anni, assenza di consenso informato firmato |
|
E.5 End points |
E.5.1 | Primary end point(s) |
cisplatin concentration in the neoplastic residual tissue |
concentrazione tissutale di cisplatino nei tessuti residui tumorali |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
60 minutes after the start of HIPEC |
60 minuti dall'avvio della perfusione |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
perioperative period |
perioperatorio |
|
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 | 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) | 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 | 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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
tecnica chirurgica HIPEC secondo due livelli di pressione intra addominale |
surgical technique HIPEC considering two levels of intra abdominal pressure |
|
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
| 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |