Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000701-77 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Ghent | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Peritoneal carcinomatosis from appendix or colon (large bowel) cancer is treated in suitable patients with surgery followed by instillation of heated chemotherapy inside the abdominal cavity. This procedure is termed 'Hyperthermic intraoperative Peritoneal Chemoperfusion' or HIPEC. Many center perform HIPEC with high dose oxaliplatin, a standard chemotherapy drug active against colon cancer, administered during 30 minutes at 41°C. The hypothesis of this study is, that chemoperfusion at normal (37.5°C) temperature but longer duration (90 minutes) may be safer and at least as efficient. Patients will be treated with one of three possible HIPEC regimens using oxaliplatin: high dose, 30 min, 41°C; high dose, 30 min, 37.5°C; or low dose, 90 min, 37.5°C. The outcome parameters are pharmacokinetic and pharmacodynamic: using specialized techniques, tissue penetration of chemotherapy and cancer cell kill effects will be compared in order to establish the safest and most active HIPEC regimen.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxaliplatin 37°C, high dose, 30 minutes | Active Comparator |
| |
| Oxaliplatin 41 °C, high dose, 30 minutes | Placebo Comparator |
| |
| Oxaliplatin 37°C, low dose, 90 minutes | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperthermic intraoperative Peritoneal Chemoperfusion | Procedure | Dose: 460 mg/m², duration: 30 minutes, temperature 37°C |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Scoring of postoperative morbidity according to the Dindo-Clavien system | Until discharge or within 30 days |
| Mortality | The number of deaths will be recorded. | Until discharge or within 30 days |
| Area under the perfusate concentration versus time curve (AUC) of platinum | Measurements of platinum in perfusate samples on the high dose interventions. | Before addition of chemotherapy, at 10, 20 and 30 minutes after addition of chemotherapy |
| Area under the perfusate concentration versus time curve (AUC) of platinum | Measurements of platinum in perfusate samples on the low dose intervention. | Before addition of chemotherapy, at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after addition of chemotherapy |
| Area under the plasma concentration versus time curve (AUC) of platinum | Measurements of platinum in perfusate samples on the high dose interventions. | Before addition of chemotherapy, at 10, 20, 30,45, 60, 90 minutes and 2, 4, 8, 12, 18, 24 hours after addition of chemotherapy |
| Area under the plasma concentration versus time curve (AUC) of platinum | Measurements of platinum in plasma samples on the low dose intervention. | Before addition of chemotherapy, at 10, 20, 30, 40, 50, 60, 70, 80, 90 minutes and 2, 4, 8, 12, 18, 24 hours after addition of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Concentration (Cmax) of Platinum | Platinum concentration will be measured after removal of perfusate. | after 30 or 90 minutes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wim P Ceelen, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | Belgium |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hyperthermic intraoperative Peritoneal Chemoperfusion | Procedure | Dose: 460 mg/m², duration: 30 minutes, temperature 41°C |
|
| Hyperthermic intraoperative Peritoneal Chemoperfusion | Drug | Dose: 200 mg/m², duration: 90 minutes, temperature 37°C |
|
| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
Not provided
Not provided