Table 1. Ongoing trials for colon, rectal and appendiceal cancers.
Trial phase | Cancer type | Treatment arm | Control arm | Sponsor/country | Primary outcome | ECD |
---|---|---|---|---|---|---|
III | Appendiceal and colorectal | CyRS + NIPEC | CyrS + HIPEC | University of Ghent, Belgium | Morbidity and mortality | 2015 |
II | Colorectal | FOLFOX + cetuximab + CyRS + HIPEC + FOLFOX | N/A | University of Regensburg, Germany | PFS | 2015 |
II | Appendiceal | CyRS + HIPEC With oxaliplatin or mitomycin-C | N/A | Wake Forest University, USA | Treatment-related toxicities | 2016 |
I/II | Colorectal | CyRS + HIPEC + MOC31PE immunotoxin | N/A | Oslo University Hospital, Norway | Adverse events and tolerability | 2016 |
III | Colorectal* | Surgery + AC + HIPEC | Surgery + AC | Gustave Roussy, France | DFS | 2016 |
I/II | Colorectal | CyRS+ HIPEC + intraperitoneal EGEN-001** | N/A | EGEN, Inc., USA | PFS, OS, and tumor growth assessment | 2017 |
III | Colorectal* | Surgery + HIPEC | Surgery | Zhejiang University, China | DFS | 2017 |
III | Colorectal* | Surgery + HIPEC | Surgery + AC | Academisch Medisch Centrum-Universiteit van Amsterdam, Netherland | RFSi | 2019 |
II | Appendiceal | CyRS + HIPEC + AC | N/A | University of California in San Diego, USA | PFS | 2020 |
*, high risk for peritoneal carcinomatosis. HIPEC is given to prophylactically; **, novel immunotherapy agent (EGEN-001—interleukin-12 gene in a biocompatible delivery polymer/http://archive.hudsonalpha.org/egen). ECD, estimated completion date; CyRS, cytoreductive surgery; NIPEC, normothermic intraperitoneal chemotherapy; HIPEC, Hyperthermic intraperitoneal chemotherapy; AC, adjuvant chemotherapy; DFS, disease free survival; PFS, progression free survival; OS, overall survival; RFS, recurrence free survival.