Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial
(2015) In BMC Cancer 15. p.1-9- 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... (More)
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 °C. Just before HIPEC, 5-fluorouracil and leucovorin will be administered intravenously. Primary endpoint is peritoneal disease-free survival at 18 months. Diagnostic laparoscopy will be performed routinely after 18 months postoperatively in both arms of the study in patients without evidence of disease based on routine follow-up using CT imaging and CEA.
DISCUSSION: Adjuvant HIPEC is assumed to reduce the expected 25 % absolute risk of PC in patients with T4 or perforated colon cancer to a risk of 10 %. This reduction is likely to translate into a prolonged overall survival.
TRIAL REGISTRATION NUMBER: NCT02231086 (Clinicaltrials.gov).
(Less)
- author
- publishing date
- 2015
- type
- Contribution to journal
- publication status
- published
- keywords
- Aged, Aged, 80 and over, Chemotherapy, Adjuvant, Chemotherapy, Cancer, Regional Perfusion/methods, Clinical Protocols, Colonic Neoplasms/pathology, Combined Modality Therapy, Female, Humans, Hyperthermia, Induced/methods, Male, Middle Aged, Peritoneal Neoplasms/secondary
- in
- BMC Cancer
- volume
- 15
- article number
- 428
- pages
- 1 - 9
- publisher
- BioMed Central (BMC)
- external identifiers
-
- pmid:26003804
- scopus:84929625351
- ISSN
- 1471-2407
- DOI
- 10.1186/s12885-015-1430-7
- language
- English
- LU publication?
- no
- id
- 5d46efff-3a97-4e9c-8e90-5ad6b49b8d49
- date added to LUP
- 2022-04-05 09:38:56
- date last changed
- 2024-06-19 12:17:15
@article{5d46efff-3a97-4e9c-8e90-5ad6b49b8d49,
abstract = {{<p>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.</p><p>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 °C. Just before HIPEC, 5-fluorouracil and leucovorin will be administered intravenously. Primary endpoint is peritoneal disease-free survival at 18 months. Diagnostic laparoscopy will be performed routinely after 18 months postoperatively in both arms of the study in patients without evidence of disease based on routine follow-up using CT imaging and CEA.</p><p>DISCUSSION: Adjuvant HIPEC is assumed to reduce the expected 25 % absolute risk of PC in patients with T4 or perforated colon cancer to a risk of 10 %. This reduction is likely to translate into a prolonged overall survival.</p><p>TRIAL REGISTRATION NUMBER: NCT02231086 (Clinicaltrials.gov).</p>}},
author = {{Klaver, Charlotte E L and Musters, Gijsbert D and Bemelman, Willem A and Punt, Cornelis J A and Verwaal, Victor J and Dijkgraaf, Marcel G W and Aalbers, Arend G J and van der Bilt, Jarmila D W and Boerma, Djamila and Bremers, Andre J A and Burger, Jacobus W A and Buskens, Christianne J and Evers, Pauline and van Ginkel, Robert J and van Grevenstein, Wilhelmina M U and Hemmer, Patrick H J and de Hingh, Ignace H J T and Lammers, Laureen A and van Leeuwen, Barbara L and Meijerink, Wilhelmus J H J and Nienhuijs, Simon W and Pon, Jolien and Radema, Sandra A and van Ramshorst, Bert and Snaebjornsson, Petur and Tuynman, Jurriaan B and Te Velde, Elisabeth A and Wiezer, Marinus J and de Wilt, Johannes H W and Tanis, Pieter J}},
issn = {{1471-2407}},
keywords = {{Aged; Aged, 80 and over; Chemotherapy, Adjuvant; Chemotherapy, Cancer, Regional Perfusion/methods; Clinical Protocols; Colonic Neoplasms/pathology; Combined Modality Therapy; Female; Humans; Hyperthermia, Induced/methods; Male; Middle Aged; Peritoneal Neoplasms/secondary}},
language = {{eng}},
pages = {{1--9}},
publisher = {{BioMed Central (BMC)}},
series = {{BMC Cancer}},
title = {{Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial}},
url = {{http://dx.doi.org/10.1186/s12885-015-1430-7}},
doi = {{10.1186/s12885-015-1430-7}},
volume = {{15}},
year = {{2015}},
}