Charlotte diepeveen

Perioperative systemic therapy comprised either four 3-week neoadjuvant and adjuvant cycles of CAPOX capecitabine and oxaliplatin , six 2-week neoadjuvant and adjuvant cycles of FOLFOX fluorouracil, leucovorin, and oxaliplatin , or six 2-week neoadjuvant cycles of FOLFIRI fluorouracil, leucovorin, and irinotecan and either four 3-week adjuvant cycles of capecitabine or six 2-week adjuvant cycles of fluorouracil with leucovorin.

Key secondary outcomes were centrally assessed rates of objective radiologic and major pathologic response of CPM to neoadjuvant treatment. Analyses were done modified intention-to-treat in patients starting neoadjuvant treatment experimental arm or undergoing upfront surgery control arm. No treatment-related deaths occurred. Conclusions and relevance: In this randomized phase 2 trial in patients diagnosed with resectable CPM, perioperative systemic therapy seemed feasible, safe, and able to induce response of CPM, justifying a phase 3 trial.

Trial registration: ClinicalTrials. Key secondary outcomes were centrally assessed rates of objective radiologic and major pathologic response of CPM to neoadjuvant treatment.

Analyses were done modified intention-to-treat in patients starting neoadjuvant treatment experimental arm or undergoing upfront surgery control arm. No treatment-related deaths occurred. Conclusions and relevance: In this randomized phase 2 trial in patients diagnosed with resectable CPM, perioperative systemic therapy seemed feasible, safe, and able to induce response of CPM, justifying a phase 3 trial. Trial registration: ClinicalTrials.

Abstract Importance: To date, no randomized clinical trials have investigated perioperative systemic therapy relative to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy CRS-HIPEC alone for resectable colorectal peritoneal metastases CPM.