Nội dung được dịch bởi AI, chỉ mang tính chất tham khảo
Liệu pháp hệ thống trong và sau phẫu thuật và phẫu thuật giảm khối u với HIPEC so với phẫu thuật giảm khối u với HIPEC đơn thuần cho di căn phúc mạc đại trực tràng có thể phẫu thuật: giao thức của một nghiên cứu đa trung tâm, không mù, nhóm song song, giai đoạn II-III, ngẫu nhiên, nghiên cứu tính ưu việt (CAIRO6)
Tóm tắt
Phẫu thuật giảm khối u ban đầu với HIPEC (CRS-HIPEC) là phương pháp điều trị tiêu chuẩn cho các di căn phúc mạc đại trực tràng có thể phẫu thuật và tách biệt tại Hà Lan. Nghiên cứu này nhằm điều tra xem việc bổ sung liệu pháp hệ thống trong và sau phẫu thuật có cải thiện kết quả ung thư học không. Đây là một nghiên cứu không mù, nhóm song song, giai đoạn II-III, ngẫu nhiên, nhằm nghiên cứu tính ưu việt được thực hiện tại chín trung tâm giới thiệu chuyên khoa cấp ba của Hà Lan. Những bệnh nhân đủ điều kiện là người lớn có tình trạng thể chất tốt, di căn có thể phẫu thuật của một u ác tính đại trực tràng được chứng minh qua mô bệnh học hoặc tế bào học, không có di căn hệ thống đại trực tràng, không có liệu pháp hệ thống điều trị ung thư đại trực tràng trong vòng sáu tháng trước khi tham gia, và không từng trải qua phẫu thuật giảm khối u với HIPEC. Các bệnh nhân đủ điều kiện sẽ được phân ngẫu nhiên (1:1) vào nhóm điều trị liệu pháp hệ thống trong và sau phẫu thuật kết hợp với CRS-HIPEC (nhóm thí nghiệm) hoặc chỉ phẫu thuật giảm khối u với HIPEC (nhóm đối chứng) bằng phần mềm phân ngẫu nhiên trung tâm, được phân bổ theo chỉ số ung thư phúc mạc từ 0–10 hoặc 11–20, di căn phúc mạc không đồng thời hoặc đồng thời, liệu pháp hệ thống trước đó cho ung thư đại trực tràng, và HIPEC với oxaliplatin hoặc mitomycin C. Theo quyết định của bác sĩ điều trị, liệu pháp hệ thống trong và sau phẫu thuật có thể bao gồm bốn chu kỳ điều trị neoadjuvant và adjuvant ba tuần với capecitabine kết hợp với oxaliplatin (CAPOX), sáu chu kỳ điều trị neoadjuvant và adjuvant hai tuần với 5-fluorouracil/leucovorin kết hợp với oxaliplatin (FOLFOX), hoặc sáu chu kỳ điều trị neoadjuvant hai tuần với 5-fluorouracil/leucovorin kết hợp irinotecan (FOLFIRI), sau đó là bốn chu kỳ điều trị adjuvant ba tuần (capecitabine) hoặc sáu chu kỳ điều trị adjuvant hai tuần (5-fluorouracil/leucovorin) với monotherapy fluoropyrimidine. Bevacizumab được thêm vào ba chu kỳ điều trị neoadjuvant đầu tiên (CAPOX) hoặc bốn chu kỳ (FOLFOX/FOLFIRI). 80 bệnh nhân đầu tiên được tuyển vào một nghiên cứu giai đoạn II để khám phá tính khả thi và an toàn, cũng như sự dung nạp của liệu pháp hệ thống trong và sau phẫu thuật. Nếu các tiêu chí về tính khả thi và an toàn được đáp ứng, nghiên cứu sẽ tiếp tục như một nghiên cứu giai đoạn III với mục tiêu chính là tỷ lệ sống sót tổng thể trong 3 năm. Tổng cộng 358 bệnh nhân cần thiết để phát hiện sự gia tăng 15% dự kiến trong tỷ lệ sống sót tổng thể trong 3 năm (nhóm đối chứng 50%; nhóm thí nghiệm 65%). Các mục tiêu phụ bao gồm các đặc điểm phẫu thuật, tỷ lệ biến chứng nghiêm trọng sau phẫu thuật, sống không tiến triển, sống không bệnh, chất lượng cuộc sống liên quan đến sức khỏe, chi phí, độc tính nghiêm trọng liên quan đến liệu pháp hệ thống, và tỷ lệ đáp ứng hình ảnh và mô bệnh học khách quan. Đây là nghiên cứu ngẫu nhiên đầu tiên so sánh trực tiếp kết quả ung thư học của liệu pháp hệ thống trong và sau phẫu thuật với CRS-HIPEC với chỉ CRS-HIPEC đơn thuần cho di căn phúc mạc đại trực tràng có thể phẫu thuật.
Từ khóa
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