TY - JOUR
T1 - Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial
AU - Bastiaenen, Vivian P
AU - Klaver, Charlotte E L
AU - Kok, Niels F M
AU - de Wilt, Johannes H W
AU - de Hingh, Ignace H J T
AU - Aalbers, Arend G J
AU - Boerma, Djamila
AU - Bremers, Andre J A
AU - Burger, Jacobus W A
AU - van Duyn, Eino B
AU - Evers, Pauline
AU - van Grevenstein, Wilhelmina M U
AU - Hemmer, Patrick H J
AU - Madsen, Eva V E
AU - Snaebjornsson, Petur
AU - Tuynman, Jurriaan B
AU - Wiezer, Marinus J
AU - Dijkgraaf, Marcel G W
AU - van der Bilt, Jarmila D W
AU - Tanis, Pieter J
PY - 2019/3/21
Y1 - 2019/3/21
N2 - BACKGROUND: Approximately 20-30% of patients with pT4 colon cancer develop metachronous peritoneal metastases (PM). Due to restricted accuracy of imaging modalities and absence of early symptoms, PM are often detected at a stage in which only a quarter of patients are eligible for curative intent treatment. Preliminary findings of the COLOPEC trial (NCT02231086) revealed that PM were already detected during surgical re-exploration within two months after primary resection in 9% of patients with pT4 colon cancer. Therefore, second look diagnostic laparoscopy (DLS) to detect PM at a subclinical stage may be considered an essential component of early follow-up in these patients, although this needs confirmation in a larger patient cohort. Furthermore, a third look DLS after a negative second look DLS might be beneficial for detection of PM occurring at a later stage.METHODS: The aim of this study is to determine the yield of second look DLS and added value of third look DLS after negative second look DLS in detecting occult PM in pT4N0-2 M0 colon cancer patients after completion of primary treatment. Patients will undergo an abdominal CT at 6 months postoperative, followed by a second look DLS within 1 month if no PM or other metastases not amenable for local treatment are detected. Patients without PM will subsequently be randomized between routine follow-up including 18 months abdominal CT, or an experimental arm with a third look DLS provided that PM or incurable metastases are absent at the 18 months abdominal CT. Primary endpoint is the proportion of PM detected after a negative second look DLS and will be determined at 20 months postoperative.DISCUSSION: Second look DLS is supposed to result in 10% occult PM, and third look DLS after negative second look DLS is expected to detect an additional 10% of PM compared to routine follow-up alone in patients with pT4 colon cancer. Detection of PM at an early stage will likely increase the proportion of patients eligible for curative intent treatment and subsequently improve survival, given the uniformly reported direct association between the extent of peritoneal disease and survival.TRIAL REGISTRATION: ClinicalTrials.gov: NCT03413254 , January 2018.
AB - BACKGROUND: Approximately 20-30% of patients with pT4 colon cancer develop metachronous peritoneal metastases (PM). Due to restricted accuracy of imaging modalities and absence of early symptoms, PM are often detected at a stage in which only a quarter of patients are eligible for curative intent treatment. Preliminary findings of the COLOPEC trial (NCT02231086) revealed that PM were already detected during surgical re-exploration within two months after primary resection in 9% of patients with pT4 colon cancer. Therefore, second look diagnostic laparoscopy (DLS) to detect PM at a subclinical stage may be considered an essential component of early follow-up in these patients, although this needs confirmation in a larger patient cohort. Furthermore, a third look DLS after a negative second look DLS might be beneficial for detection of PM occurring at a later stage.METHODS: The aim of this study is to determine the yield of second look DLS and added value of third look DLS after negative second look DLS in detecting occult PM in pT4N0-2 M0 colon cancer patients after completion of primary treatment. Patients will undergo an abdominal CT at 6 months postoperative, followed by a second look DLS within 1 month if no PM or other metastases not amenable for local treatment are detected. Patients without PM will subsequently be randomized between routine follow-up including 18 months abdominal CT, or an experimental arm with a third look DLS provided that PM or incurable metastases are absent at the 18 months abdominal CT. Primary endpoint is the proportion of PM detected after a negative second look DLS and will be determined at 20 months postoperative.DISCUSSION: Second look DLS is supposed to result in 10% occult PM, and third look DLS after negative second look DLS is expected to detect an additional 10% of PM compared to routine follow-up alone in patients with pT4 colon cancer. Detection of PM at an early stage will likely increase the proportion of patients eligible for curative intent treatment and subsequently improve survival, given the uniformly reported direct association between the extent of peritoneal disease and survival.TRIAL REGISTRATION: ClinicalTrials.gov: NCT03413254 , January 2018.
KW - Adult
KW - Aftercare/methods
KW - Aged
KW - Clinical Trials, Phase III as Topic
KW - Colonic Neoplasms/diagnostic imaging
KW - Diagnostic laparoscopy
KW - Early Detection of Cancer/methods
KW - Early detection
KW - Female
KW - Humans
KW - Laparoscopy/methods
KW - Male
KW - Middle Aged
KW - Peritoneal Neoplasms/diagnosis
KW - Peritoneal metastases
KW - Peritoneum/diagnostic imaging
KW - Prospective Studies
KW - Randomized Controlled Trials as Topic
KW - Second-Look Surgery/methods
KW - Second/third look surgery
KW - T4 colon cancer
KW - Young Adult
UR - http://www.scopus.com/inward/record.url?scp=85063354881&partnerID=8YFLogxK
U2 - 10.1186/s12885-019-5408-8
DO - 10.1186/s12885-019-5408-8
M3 - Article
C2 - 30898098
SN - 1471-2407
VL - 19
SP - 1
EP - 12
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 254
ER -