HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma
A. Arjona-Sánchez,
P. Barrios,
E. Boldo-Roda,
B. Camps,
J. Carrasco-Campos,
V. Concepción Martín,
A. García-Fadrique,
A. Gutiérrez-Calvo,
R. Morales,
G. Ortega-Pérez,
E. Pérez-Viejo,
A. Prada-Villaverde,
J. Torres-Melero,
E. Vicente,
P. Villarejo-Campos,
J. M. Sánchez-Hidalgo,
A. Casado-Adam,
Ruben García-Martin,
Manuel Medina,
T. Caro,
C. Villar,
Enrique Aranda,
M. T. Cano-Osuna,
C. Díaz-López,
E. Torres-Tordera,
F. J. Briceño-Delgado,
S. Rufián-Peña
Affiliations
A. Arjona-Sánchez
Unit of Oncologic and Pancreatic Surgery, Hospital University Reina Sofía
P. Barrios
Unit of Surgery, Consorci Sanitari Integral, Hospital de Sant Joan Despí Moises Broggi
E. Boldo-Roda
Unit of Surgery, Hospital Provincial Castellón
B. Camps
Unit of Oncologic Surgery, Hospital Clinico Universitary Valencia
J. Carrasco-Campos
Unit of Surgery, Hospital Regional University of Malaga
V. Concepción Martín
Unit of Peritoneal Oncologic Surgery and Colorectal Surgery, Hospital University Nuestra Señora de la Candelaria
A. García-Fadrique
Department of Surgery, Instituto Valenciano de Oncología
A. Gutiérrez-Calvo
Surgery Department, Unit of Peritoneal Oncologic Surgery, Hospital Príncipe de Asturias, Alcalá de Henares
R. Morales
Unit of Oncologic and Pancreatic Surgery, Hospital Son Spaces
G. Ortega-Pérez
MD Anderson Cancer Center
E. Pérez-Viejo
Unit of Oncologic Surgery, Hospital University Fuenlabrada
A. Prada-Villaverde
Unit of Surgery, Hospital University Infanta Cristina
J. Torres-Melero
Unit of Surgery. Hospital de Torrecárdenas
E. Vicente
Department of Surgery, Sanchinarro University Hospital. “Clara Campal” Oncological Center. San Pablo University. CEU
P. Villarejo-Campos
Unit of Surgery, Hospital University Ciudad Real
J. M. Sánchez-Hidalgo
Unit of Oncologic and Pancreatic Surgery, Hospital University Reina Sofía
A. Casado-Adam
Unit of Oncologic and Pancreatic Surgery, Hospital University Reina Sofía
Ruben García-Martin
Unit of Oncologic and Pancreatic Surgery, Hospital University Reina Sofía
Manuel Medina
CIBERehd, IMIBIC, Hospital University Reina Sofía
T. Caro
CIBERehd, IMIBIC, Hospital University Reina Sofía
C. Villar
CIBERehd, IMIBIC, Hospital University Reina Sofía
Enrique Aranda
CIBERehd, IMIBIC, Hospital University Reina Sofía
M. T. Cano-Osuna
CIBERehd, IMIBIC, Hospital University Reina Sofía
C. Díaz-López
CIBERehd, IMIBIC, Hospital University Reina Sofía
E. Torres-Tordera
Unit of Colorectal Surgery, Hospital University Reina Sofia
F. J. Briceño-Delgado
Unit of Oncologic and Pancreatic Surgery, Hospital University Reina Sofía
S. Rufián-Peña
Unit of Oncologic and Pancreatic Surgery, Hospital University Reina Sofía
Abstract Background 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%. 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/Design The 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. Discussion We 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 registration NCT02614534 (clinicaltrial.gov) Nov-2015.
