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Trial record 80 of 480 for:    colon cancer AND resection

Second and Third Look Laparoscopy in pT4 Colon Cancer Patients for Early Detection of Peritoneal Metastases (COLOPEC-II)

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ClinicalTrials.gov Identifier: NCT03413254
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
P.J. Tanis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
The COLOPEC II multicentre randomized trial will investigate the role of second and third look laparoscopy to detect metachronous peritoneal metastases at a clinically occult stage during the follow-up of pT4 colon cancer patients. It is expected that detection of PM at a clinically occult stage will translate into survival benefit, due to higher percentage of patients eligible for curative intent treatment with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Peritoneal Metastases Other: Routine follow-up Procedure: Second look DLS Procedure: Third look DLS Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 389 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: In order to prevent caretakers from being influenced by the assigned follow-up strategy, the randomization outcome will remain unknown to everyone involved in the patient's care until the 18 months CT-scan is reported by the radiologist.
Primary Purpose: Diagnostic
Official Title: Second and Third Look Laparoscopy in pT4 Colon Cancer Patients for Early Detection of Peritoneal Metastases; the COLOPEC-II Randomized Multicentre Trial
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : February 1, 2025

Arm Intervention/treatment
Active Comparator: 2nd look DLS + routine FU
Follow-up after curatively resected pT4 colon cancer, consisting of second look DLS after negative CT abdomen at 6-9 months and normal CEA, with subsequent routine follow-up according to the Dutch colorectal cancer guideline until 5 years.
Other: Routine follow-up
Patients visit the outpatient clinic twice a year during the first two to three years and annually thereafter, until five years postoperative. CEA-levels are determined at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48 and 60 months after primary resection. Detection of liver metastases with ultrasound or CT is performed at 12, 24, 36, 48 and 60 months postoperative. At 6 and 18 months postoperative, a CT-scan is part of the study protocol, but ultrasound of the liver is allowed for other time intervals during follow-up. Colonoscopy is performed at 12 and 48 months postoperative.

Procedure: Second look DLS
Second look DLS is performed within one month from negative CT at 6-9 months (depending last date of adjuvant chemotherapy) and normal CEA. Laparoscopic access to the abdominal cavity is obtained under general anaesthesia, followed by adhesiolysis if necessary. Complete staging is performed, with biopsy of any lesion suspicious of PM, and determining the peritoneal cancer index (PCI) in case of PM. Conversion to laparotomy not allowed for better exposure, but only for intra-operative complications.

Experimental: 2nd and 3rd DLS + routine FU
Follow-up after curatively resected pT4 colon cancer, consisting of second look DLS after negative CT abdomen at 6-9 months and normal CEA, with subsequent routine follow-up and third look DLS after negative CT abdomen at 18 months and normal CEA. Third look DLS is not performed in patients with evidence of disease that is not curable, or in those already diagnosed with PM in the preceding period.
Other: Routine follow-up
Patients visit the outpatient clinic twice a year during the first two to three years and annually thereafter, until five years postoperative. CEA-levels are determined at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48 and 60 months after primary resection. Detection of liver metastases with ultrasound or CT is performed at 12, 24, 36, 48 and 60 months postoperative. At 6 and 18 months postoperative, a CT-scan is part of the study protocol, but ultrasound of the liver is allowed for other time intervals during follow-up. Colonoscopy is performed at 12 and 48 months postoperative.

Procedure: Second look DLS
Second look DLS is performed within one month from negative CT at 6-9 months (depending last date of adjuvant chemotherapy) and normal CEA. Laparoscopic access to the abdominal cavity is obtained under general anaesthesia, followed by adhesiolysis if necessary. Complete staging is performed, with biopsy of any lesion suspicious of PM, and determining the peritoneal cancer index (PCI) in case of PM. Conversion to laparotomy not allowed for better exposure, but only for intra-operative complications.

Procedure: Third look DLS
Third look DLS is performed within one month from negative CT at 18 months and normal CEA. Laparoscopic access to the abdominal cavity is obtained under general anaesthesia, followed by adhesiolysis if necessary. Complete staging is performed, with biopsy of any lesion suspicious of PM, and determining the peritoneal cancer index (PCI) in case of PM. Conversion to laparotomy not allowed for better exposure, but only for intra-operative complications.




Primary Outcome Measures :
  1. Proportion of peritoneal metastases detected after a negative second look DLS [ Time Frame: 20 months ]
    Peritoneal metastases that are detected using either routine follow-up or third look DLS according to randomization.


Secondary Outcome Measures :
  1. Incidence of PM at second look DLS after curative treatment of primary tumour, depending on pathological pT4 stage, pathological nodal stage and histology [ Time Frame: 6-10 months ]
    Occult peritoneal metastases not detected by routine CT scan 6-9 months after primary resection of pT4 colon cancer, that are detected at second look DLS performed at 6-10 months after the primary resection.

  2. Incidence of PM during first 20 months after curative resection of primary tumour, depending on pathological pT4 stage, pathological nodal stage and histology [ Time Frame: 20 months ]
    This outcome measure tries to stratify pT4 colon cancer patients in clinically relevant subgroups based on their risk to develop PM.

  3. Incidence of PM in patients who did or did not undergo adjuvant chemotherapy [ Time Frame: 20 months ]
    This outcome measure analysis a potential impact of adjuvant chemotherapy on the development of PM.

  4. Sensitivity, specificy, NPV and PPV of CT imaging to detect PM compared to DLS [ Time Frame: 20 months ]
    Diagnostic accuracy of CT using DLS findings as gold standard.

  5. Proportion of detected PM eligible for curative intent CRS+HIPEC at different follow-up intervals [ Time Frame: 20 months ]
    This outcome measures determines the clinical impact of PM detection, considering potentially curative intent treatment.

  6. 30-day morbidity related to second/third look DLS [ Time Frame: From the second or third look DLS till 30 days postoperative ]
    This outcome measure is important to determine the harm/benefit ratio of DLS.

  7. Extent of adhesiolysis required at second/third look DLS assessed with the Zühlke score [ Time Frame: 20 months ]

    The Zühlke score measures the severity of intraabdominal adhesions.

    1. Filmy adhesions.
    2. Stronger adhesions requiring some sharp dissection.
    3. Dense vascularized adhesions requiring sharp dissection.
    4. Extreme dense vascularized adhesions with high risk for organ damage during dissection.

    A higher score indicates a worse outcome.


  8. 5-year peritoneal recurrence free survival [ Time Frame: 5 years ]
    This outcome measure determines whether third look DLS has any impact on the overall detection of PM.

  9. 5-year disease-free survival [ Time Frame: 5 years ]
    Important long-term oncological endpoint to determine the potential oncological benefit of third look DLS.

  10. 5-year overall survival [ Time Frame: 5 years ]
    Important long-term oncological endpoint to determine the potential oncological benefit of third look DLS.

  11. Quality of life assessed with the CRC-29 questionnaire [ Time Frame: 2 years ]
    Assessing impact of invasive diagnostic procedures on QOL.

  12. Quality of life assessed with the EQ-5D-5L questionnaire [ Time Frame: 2 years ]
    Assessing impact of invasive diagnostic procedures on QOL.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Curative intent resection of pT4a,bN0-2M0 colon cancer or rectosigmoid cancer above the peritoneal reflection, with or without adjuvant systemic therapy;
  • Age between 18 and 80 years;
  • Written informed consent.

Exclusion Criteria:

  • Histological subtype other than (mucinous) adenocarcinoma or signet-ring cell carcinoma;
  • Clinical condition that does not allow for second look surgery or subsequent treatment of PM if detected;
  • Second look surgery thought not to be technically possible (i.e. because of extensive abdominal surgery / re-interventions).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413254


Contacts
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Contact: Vivian P. Bastiaenen, M.D. +31205665199 V.P.Bastiaenen@amc.nl
Contact: Pieter J. Tanis, M.D. PhD P.J.Tanis@amc.nl

Locations
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Netherlands
Flevoziekenhuis Recruiting
Almere, Netherlands
Contact: Jarmila van der Bilt, MD PhD         
Amsterdam UMC, location AMC Recruiting
Amsterdam, Netherlands
Contact: Vivian Bastiaenen, MD    0031205665199    V.P.Bastiaenen@amc.nl   
Amsterdam UMC, location VUmc Recruiting
Amsterdam, Netherlands
Contact: Jurriaan Tuynman, MD PhD         
Antoni van Leeuwenhoek Recruiting
Amsterdam, Netherlands
Contact: Arend Aalbers, MD         
OLVG Recruiting
Amsterdam, Netherlands
Contact: Tom Karsten, MD PhD         
Catharina hospital Recruiting
Eindhoven, Netherlands
Contact: Ignace de Hingh, MD PhD         
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: Patrick Hemmer, MD         
St. Antonius hospital Recruiting
Nieuwegein, Netherlands
Contact: Djamila Boerma, MD PhD         
Radboudumc Recruiting
Nijmegen, Netherlands
Contact: Hans de Wilt, MD PhD         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands
Contact: Helma van Grevenstein, MD PhD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: P.J. Tanis, M.D. PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03413254    
Other Study ID Numbers: NL61507.018.17
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by P.J. Tanis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
pT4 colon cancer
Peritoneal metastases
Early detection
Diagnostic laparoscopy
Second look surgery
Third look surgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Neoplastic Processes
Pathologic Processes