Multicentre Phase IV clinical trial to evaluate the efficacy of hyperthermic intraoperative chemotherapy (HIPEC) with Mitomycin-C after complete surgical debulking in patients with peritoneal metastases of colon cancer.

Conditions

peritoneal metastases of colorectal cancer

Brief summary

peritoneal recurrence-free survival at 1, 2 and 3 years.

Detailed description

Overall recurrence (ORS) at 1, 2 and 3 years., Locoregional and distant recurrence (isolated or coincident, with or without simultaneous peritoneal recurrence) at 1, 2, and 3 years., Postoperative complications using the CTCAE v5.0 90-day adverse event classification system, including those related to HIPEC., Prognostic factors for peritoneal and global recurrence: synchronous/metachronous PM, perioperative QTS, use of biological agents or immunotherapy, stratified PCI (1-10, 11-15, 16-20), postoperative complications, right/left colon, degree of differentiation, vascular/lymphatic/perineural invasion, RAS/RAF status, microsatellite instability and degree of peritoneal tumour regression., Overall survival at 1, 2 and 3 years., Study of Quality of Life in both groups using the EORTC QLQ-C30 and QLQ-CR29 questionnaires (APPENDIX IV), to be carried out at the aforementioned times., Correlation surgical PCI - pathological PCI

Related papers

No related papers found yet.

Interventions

DRUGMitomicina Accord 40 mg polvo para solución inyectable y para perfusión EFG

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
peritoneal recurrence-free survival at 1, 2 and 3 years.	—

Secondary

Measure	Time frame
Overall recurrence (ORS) at 1, 2 and 3 years., Locoregional and distant recurrence (isolated or coincident, with or without simultaneous peritoneal recurrence) at 1, 2, and 3 years., Postoperative complications using the CTCAE v5.0 90-day adverse event classification system, including those related to HIPEC., Prognostic factors for peritoneal and global recurrence: synchronous/metachronous PM, perioperative QTS, use of biological agents or immunotherapy, stratified PCI (1-10, 11-15, 16-20), postoperative complications, right/left colon, degree of differentiation, vascular/lymphatic/perineural invasion, RAS/RAF status, microsatellite instability and degree of peritoneal tumour regression., Overall survival at 1, 2 and 3 years., Study of Quality of Life in both groups using the EORTC QLQ-C30 and QLQ-CR29 questionnaires (APPENDIX IV), to be carried out at the aforementioned times., Correlation surgical PCI - pathological PCI	—

Measure

Time frame

Overall recurrence (ORS) at 1, 2 and 3 years., Locoregional and distant recurrence (isolated or coincident, with or without simultaneous peritoneal recurrence) at 1, 2, and 3 years., Postoperative complications using the CTCAE v5.0 90-day adverse event classification system, including those related to HIPEC., Prognostic factors for peritoneal and global recurrence: synchronous/metachronous PM, perioperative QTS, use of biological agents or immunotherapy, stratified PCI (1-10, 11-15, 16-20), postoperative complications, right/left colon, degree of differentiation, vascular/lymphatic/perineural invasion, RAS/RAF status, microsatellite instability and degree of peritoneal tumour regression., Overall survival at 1, 2 and 3 years., Study of Quality of Life in both groups using the EORTC QLQ-C30 and QLQ-CR29 questionnaires (APPENDIX IV), to be carried out at the aforementioned times., Correlation surgical PCI - pathological PCI

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Countries

Spain

Outcome results

None listed