
pmid: 30898098
pmc: PMC6429794
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.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.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.ClinicalTrials.gov: NCT03413254 , January 2018.
Male, Cancer Research, CARCINOMATOSIS, Aftercare, COLORECTAL-CANCER, Laparoscopy/methods, Study Protocol, Prospective Studies, RC254-282, Early Detection of Cancer, Peritoneal Neoplasms, Randomized Controlled Trials as Topic, RISK, OUTCOMES, ORIGIN, Colonic Neoplasms/diagnostic imaging, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Early detection, Middle Aged, Multicenter Study, Peritoneum/diagnostic imaging, Oncology, Colonic Neoplasms, Second-Look Surgery/methods, EMC MM-03-47-11, Female, HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY, Peritoneum, Radboudumc 10: Reconstructive and regenerative medicine RIHS: Radboud Institute for Health Sciences, Surgery - Radboud University Medical Center, Adult, Radboud University Medical Center, Aftercare/methods, Diagnostic laparoscopy, CHEMOPERFUSION, Young Adult, SDG 3 - Good Health and Well-being, Genetics, Journal Article, Humans, T4 colon cancer, Aged, Peritoneal Neoplasms/diagnosis, Second, Radboudumc 14: Tumours of the digestive tract RIHS: Radboud Institute for Health Sciences, Second/third look surgery, Peritoneal metastases, Clinical Trials, Phase III as Topic, third look surgery, CYTOREDUCTIVE SURGERY, Second-Look Surgery, CURATIVE TREATMENT, SYSTEMIC CHEMOTHERAPY, Laparoscopy, Early Detection of Cancer/methods
Male, Cancer Research, CARCINOMATOSIS, Aftercare, COLORECTAL-CANCER, Laparoscopy/methods, Study Protocol, Prospective Studies, RC254-282, Early Detection of Cancer, Peritoneal Neoplasms, Randomized Controlled Trials as Topic, RISK, OUTCOMES, ORIGIN, Colonic Neoplasms/diagnostic imaging, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Early detection, Middle Aged, Multicenter Study, Peritoneum/diagnostic imaging, Oncology, Colonic Neoplasms, Second-Look Surgery/methods, EMC MM-03-47-11, Female, HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY, Peritoneum, Radboudumc 10: Reconstructive and regenerative medicine RIHS: Radboud Institute for Health Sciences, Surgery - Radboud University Medical Center, Adult, Radboud University Medical Center, Aftercare/methods, Diagnostic laparoscopy, CHEMOPERFUSION, Young Adult, SDG 3 - Good Health and Well-being, Genetics, Journal Article, Humans, T4 colon cancer, Aged, Peritoneal Neoplasms/diagnosis, Second, Radboudumc 14: Tumours of the digestive tract RIHS: Radboud Institute for Health Sciences, Second/third look surgery, Peritoneal metastases, Clinical Trials, Phase III as Topic, third look surgery, CYTOREDUCTIVE SURGERY, Second-Look Surgery, CURATIVE TREATMENT, SYSTEMIC CHEMOTHERAPY, Laparoscopy, Early Detection of Cancer/methods
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