Abstract
BackgroundLocal relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. There are promising results using prophylactic HIPEC in this group of patients, and it is estimated that up to 26% of all T4 colon cancer could benefit from this treatment with a minimal morbidity. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection. Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs. standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4).Methods/DesignThe aim of this study is to determine the effectiveness and safety of adjuvant HIPEC in preventing the development of PC in patients with colon cancer with a high risk of peritoneal recurrence (cT4). This study will be carried out in 15 Spanish HIPEC centres. Eligible for inclusion are patients who underwent curative resection for cT4NxM0 stage colon cancer. After resection of the primary tumour, 200 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously after the primary resection. Mitomycin C will be used as chemotherapeutic agent, for 60 min at 42–43 °C. Primary endpoint is loco-regional control (LC) in months and the rate of loco-regional control (%LC) at 12 months and 36 months after resection.DiscussionWe assumed that adjuvant HIPEC will reduce the expected absolute risk of peritoneal recurrence from 36% to 18% at 36 months for T4 colon-rectal carcinoma.Trial registrationNCT02614534 (clinicaltrial.gov) Nov-2015.
Highlights
Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%
The effectiveness of cytoreductive surgery (CRS) and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) in carcinomatosis from CRC depends on disease spread (PCI) and completeness of cytoreduction (CC), if the complete cytoreduction is achieve, the 5 years survival rates could reach between 45 and 51% in combination with HIPEC
In selected cases with limited peritoneal carcinomatosis without distant metastasis, the CRS + HIPEC represents an attractive and defendable treatment as several phase II and III studies show that CRS + HIPEC improves the survival when is compared with systemic chemotherapy alone [7, 8]
Summary
Local relapse and peritoneal carcinomatosis (PC) for pT4 colon cancer is estimated in 15,6% and 36,7% for 12 months and 36 months from surgical resection respectively, achieving a 5 years overall survival of 6%. Adjuvant HIPEC is effective to avoid the possibility of peritoneal seeding after surgical resection Taking into account these results and the cumulative experience in HIPEC use, we will lead a randomized controlled trial to determine the effectiveness and safety of adjuvant treatment with HIPEC vs standard treatment in patients with colon cancer at high risk of peritoneal recurrence (pT4). One of the risk factors identified to develop PC is the trans-serosal invasion of the tumour (pT4 a-b) [3, 4] This feature represents a significant risk factor for survival by itself, in this way, the prognosis of pT4 becomes similar to patients with N2 and M1 stages with a 5 years overall survival of 20% [5]. In selected cases with limited peritoneal carcinomatosis without distant metastasis, the CRS + HIPEC represents an attractive and defendable treatment as several phase II and III studies show that CRS + HIPEC improves the survival when is compared with systemic chemotherapy alone [7, 8]
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