Abstract 164TiP
Background
Colorectal cancer (CRC) accounts for 10% of global cancer deaths yearly. It is postulated that the incidence rates are rising in developing countries like India. From 2004 to 2014 CRC incidence rates in India increased by 20%. During 2004-2005, the incidence rate of CRC was 5.8 per 100,000 persons. It increased to 6.9 during 2012-2014. The rising rates can be attributed to changing lifestyles that include consumption of calorie-rich and low fibre diet, excessive use of red meat and processed foods, and physical inactivity. Peritoneal metastases (PM) are common in advanced-stage colorectal cancer (CRC) patients representing the second most common metastatic site of CRC. However, the inclusion of treatment options such as cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) as inherent components of a multidisciplinary treatment was evolving for the management of these patients. In colorectal cancer (CRC), the first formal RCT assessing the benefit added to surgery by using 30 min of oxaliplatin-based HIPEC, failed to show improved survival (PRODIGE 7 trial).Though the efficacy of HIPEC using Mitomycin-C has been proven in colorectal cancer,our study is to see the impact(OS,DFS) of double agent (Cisplatin+Mitomycin-c) during HIPEC in patients with colorectal cancer.
Trial design
Inclusion criteria: Age 18-70yrs ECOG -0/1 Preoperative PCI<15 (CECT/MRI) Adequate liver function Adequate renal function Absolute neutrophril count (>1.5x109) Platelet count(100x109) Upto 3 liver metastasis Intraoperative CCR (0-1) Exclusion criteria: Unresectable disease Metastatic disease More than 3 liver metastasis Previous history of HIPEC Poor PFS (ECOG>=2) Deranged LFT or KFT Patient with neutropepenia TRIAL DESIGN Eligible patients of colorectal cancer included for CRS and HIPEC | Intraoperative 1:1 randomization | Arm 1 Arm 2 CRS with HIPEC using CRS only Cisplatin (70mg/m2) + Mitomycin C (30mg/m2) for 60 mins. | Adjuvant systemic therapy X 6 cycles | Follow up for 36 months and survival analysis (OS,DFS).
Legal entity responsible for the study
The author.
Funding
Has not received any funding.
Disclosure
The author has declared no conflicts of interest.