CLASS-05 trial: A randomized controlled phase III trial of cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (HIPEC) + systemic chemotherapy vesus systemic chemotherapy alone for patients with limited peritoneal carcinomatosis of gastric cancer

Background: Peritoneal metastasis (PM) is detected synchronously in ∼30% of patients with advanced gastric cancer (AGC), which has been considered as late stage of the disease with a poor prognosis and were generally treated with systemic chemotherapy or best supportive care. Two new surgical modalities that have evolved to manage PM are cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). Our and other published retrospective data suggested that CRS plus HIPEC may prolong overall survival of the patients with limited PM. Still, the solid evidences based on large randomized clinical trials (RCT) are lacking. Accordingly, the present trial was initiated to define a comprehensive treatment. Trial design: The investigator-initiated, multicenter, prospective two-arm RCT is comparing efficacy of CRS followed by HIPEC (CRS+HIPEC) versus chemotherapy (5-Fu based regimen, Chemo) alone for the treatment of AGC with limited PM. Eligibility for the trial is given in cT3-4NxM1 (M1 limited to peritoneum, PCI score < 20 evaluated by diagnostic laparoscopy)AGC. The trial will recruit 220 participants who are 1:1 randomized to one of two arms after diagnostic laparoscopy. Participants enrolled in the Chemo study arm will receive standard chemotherapy according to the NCCN guideline. The CRS+HIPEC study arm will receive D2 gastrectomy plus peritonectomy plus HIPEC followed by systemic chemotherapy. The primary endpoint of the trial is overall survival. The secondary endpoints include progression-free survival, morbidity and mortality and quality of life. Biological substudies on biomarkers are included. Current status: The trial was approved by the Ethical Committee of Nanfang hospital, Southern Medical University, Guangzhou, China. Patient recruitment has begun in January 2017. Overall 12 Chinese sites will commence recruitment in 2017. Clinical trial identification: NCT03023436 Legal entity responsible for the study: Nanfang Hospital, Southern Medical University Funding: None Disclosure: All authors have declared no conflicts of interest.