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Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial

Authors :
Klaver, CEL
Musters, GD
Bemelman, WA
Punt, CJA
Verwaal, VJ
Dijkgraaf, MGW
Aalbers, AGJ (Arend)
van der Bilt, JDW
Boerma, D
Bremers, AJA
Burger, Pim
Buskens, CJ
Evers, P
van Ginkel, RJ
Grevenstein, WMU
Hemmer, PHJ
de Hingh, IHJT
Lammers, LA
van Leeuwen, BL
Meijerink, WJHJ
Nienhuijs, SW
Pon, J
Radema, SA
van Ramshorst, B
Snaebjornsson, P
Tuynman, JB
te Velde, EA
Wiezer, MJ
de Wilt, JHW (Johannes)
Tanis, PJ
Klaver, CEL
Musters, GD
Bemelman, WA
Punt, CJA
Verwaal, VJ
Dijkgraaf, MGW
Aalbers, AGJ (Arend)
van der Bilt, JDW
Boerma, D
Bremers, AJA
Burger, Pim
Buskens, CJ
Evers, P
van Ginkel, RJ
Grevenstein, WMU
Hemmer, PHJ
de Hingh, IHJT
Lammers, LA
van Leeuwen, BL
Meijerink, WJHJ
Nienhuijs, SW
Pon, J
Radema, SA
van Ramshorst, B
Snaebjornsson, P
Tuynman, JB
te Velde, EA
Wiezer, MJ
de Wilt, JHW (Johannes)
Tanis, PJ
Source :
Klaver , CEL , Musters , GD , Bemelman , WA , Punt , CJA , Verwaal , VJ , Dijkgraaf , MGW , Aalbers , AGJ , van der Bilt , JDW , Boerma , D , Bremers , AJA , Burger , P , Buskens , CJ , Evers , P , van Ginkel , RJ , Grevenstein , WMU , Hemmer , PHJ , de Hingh , IHJT , Lammers , LA , van Leeuwen , BL , Meijerink , WJHJ , Nienhuijs , SW , Pon , J , Radema , SA , van Ramshorst , B , Snaebjornsson , P , Tuynman , JB , te Velde , EA , Wiezer , MJ , de Wilt , JHW & Tanis , PJ 2015 , ' Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial ' , BMC Cancer , vol. 15 .
Publication Year :
2015

Abstract

Background: The peritoneum is the second most common site of recurrence in colorectal cancer. Early detection of peritoneal carcinomatosis (PC) by imaging is difficult. Patients eventually presenting with clinically apparent PC have a poor prognosis. Median survival is only about five months if untreated and the benefit of palliative systemic chemotherapy is limited. Only a quarter of patients are eligible for curative treatment, consisting of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CR/HIPEC). However, the effectiveness depends highly on the extent of disease and the treatment is associated with a considerable complication rate. These clinical problems underline the need for effective adjuvant therapy in high-risk patients to minimize the risk of outgrowth of peritoneal micro metastases. Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) seems to be suitable for this purpose. Without the need for cytoreductive surgery, adjuvant HIPEC can be performed with a low complication rate and short hospital stay. Methods/Design: The aim of this study is to determine the effectiveness of adjuvant HIPEC in preventing the development of PC in patients with colon cancer at high risk of peritoneal recurrence. This study will be performed in the nine Dutch HIPEC centres, starting in April 2015. Eligible for inclusion are patients who underwent curative resection for T4 or intra-abdominally perforated cM0 stage colon cancer. After resection of the primary tumour, 176 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 or shortly after the primary resection. Oxaliplatin will be used as chemotherapeutic agent, for 30 min at 42-43 degrees C. Just before HIPEC, 5-fluorouracil and leucovorin will be administered intravenously. Primary endpoint is peritoneal disease-free survival at 1

Details

Database :
OAIster
Journal :
Klaver , CEL , Musters , GD , Bemelman , WA , Punt , CJA , Verwaal , VJ , Dijkgraaf , MGW , Aalbers , AGJ , van der Bilt , JDW , Boerma , D , Bremers , AJA , Burger , P , Buskens , CJ , Evers , P , van Ginkel , RJ , Grevenstein , WMU , Hemmer , PHJ , de Hingh , IHJT , Lammers , LA , van Leeuwen , BL , Meijerink , WJHJ , Nienhuijs , SW , Pon , J , Radema , SA , van Ramshorst , B , Snaebjornsson , P , Tuynman , JB , te Velde , EA , Wiezer , MJ , de Wilt , JHW & Tanis , PJ 2015 , ' Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial ' , BMC Cancer , vol. 15 .
Notes :
application/pdf, und
Publication Type :
Electronic Resource
Accession number :
edsoai.on1313618845
Document Type :
Electronic Resource