Table 2:
Prospective randomized trials evaluating CRS and HIPEC in colorectal cancer.
| Indication | Acronym | Principal investigator | Country | Opened | Status | Accrual needed | Patients recruited (November 2016) | Drug IP | M/M results | Oncological outcome | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Prophylactic (patients without peritoneal metastasis) | |||||||||||
| 1 | NCT01226394 | ProphyloCHIP (PRODIGE 15) | Goere D | France | April 2010 | Active | 130 | 130 | Oxaliplatin | Presented | N/A |
| 2 | NCT02179489 | N/A | Sun L | China | October 2014 | Recruiting | 300 | N/A | MMC | N/A | N/A |
| 3 | NCT02231086 | COLOPEC | Tanis PJ | Netherlands | March 2015 | Recruiting | 200 | 181 | Oxaliplatin | N/A | N/A |
| 4 | NCT02614534 | HIPECT4 | Arjona-Sanchez | Spain | November 2015 | Recruiting | 190 | N/A | MMC | N/A | N/A |
| 5 | NCT02965248 | APEC | Cai G | China | November 2016 | Recruiting | 147 | 0 | Raltitrexed Oxaliplatin | N/A | N/A |
| 6 | NCT02974556 | PROMENADE | Sammartino P | Italy | March 2017 | Not yet recruiting | 140 | 0 | Oxaliplatin | N/A | N/A |
| Total | 1107 | ||||||||||
| Therapeutic (patients with peritoneal metastasis) | |||||||||||
| 1 | N/A | N/A | Verwaal VJ | Netherlands | February 1995 | Closed | 105 | 105 | MMC | Published | Published |
| 2 | NCT00769405 | PRODIGE 7 | Quenet F | France | February 2008 | Active | 264 | 265 | Oxaliplatin | Presented | Exp. 2017 |
| 3 | NCT01540344 | COMBATAC | Piso P | Germany | October 2010 | Terminated | 60 | 20 | Oxaliplatin | Presented | Exp. 2017 |
| 4 | NCT01628211 | HIPEC | Perrone F | Italy | April 2012 | Recruiting | 140 | N/A | Oxaliplatin | N/A | N/A |
| 5 | NCT01815359 | ICArUS | Nash G | USA | April 2013 | Recruiting | 212 | 94 | MMC | Presented | N/A |
| Total | 781 | ||||||||||
CDDP, cisplatin; MMC, mitomycin C; N/A, not available to date (November 2016); Exp., expected. Green: results published. Yellow: patient accrual completed.