drugset / Trial / NCT02974556

Proactive Management of Endoperitoneal Spread in Colonic Cancer

NCT02974556 ↗

Phase 3 Unknown 140 enrolled University of Roma La Sapienza
RandomizedParallel-groupDouble-blindPrevention

Summary

This study aims to determine the oncological effectiveness, compared to standard surgical treatment, of proactive management including target organs for peritoneal spread resection (omentectomy, bilateral adnexectomy, appendectomy, hepatic round ligament resection) and preventive HIPEC (intraperitoneal oxaliplatin with concomitant i.v. 5-fluorouracil/leucovorin) following a curative resection of high-risk ( \>/= 5 mm tumor invasion beyond the muscularis propria) T3 and T4 colon cancer in preventing the development of peritoneal metastases. Adjuvant systemic chemotherapy will be reserved in both groups for patients with poor prognostic factors according to Folinic acid/Fluorouracil/Oxaliplatin (FOLFOX) or to Capecitabine/Oxaliplatin (CAPOX) regimens. Hypothesis: The hypothesis is that compared to the standard treatment proactive management following curative resection of high-risk T3 and T4 colon cancer will reduce the development of endoperitoneal metastases

Timeline

Start
2024-03-01
Primary completion
2024-09-01
Completion
2025-09

Drugs

EvaluationDrugModalityDoseRoute
Background Capecitabine Small molecule — —
Background Oxaliplatin Small molecule — Other
Background fluorouracil Small molecule — Intravenous