Clinical Trial: Second Look Laparoscopy in Colorectal Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Phase 2 Study Comparing Second Look Laparoscopy to Standard Follow up in Patients With no Radiologic Evidence of Disease at 6 Months After Complete Resection of Colorectal

Current Secondary Outcome:

  • number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm [ Time Frame: 6 months ]
  • changes in quality of life [ Time Frame: 6 months ]
    quality of life is measured at baseline and 6 months after randomization
  • overall survival [ Time Frame: five years ]
  • worst grade adverse event per patient [ Time Frame: 7 months ]
    toxicity measured only in experimental arm, weekly from randomization to 30 days after experimental treatment
  • number of patients with radiologic evidence of disease after initial surgery [ Time Frame: 6 months ]
  • list of therapies and clinical outcomes of patients who had radiologic evidence of disease within 6 months after initial surgery [ Time Frame: two years ]
    description of therapies and outcomes for those patients who were not randomized due to presence of disease


Original Secondary Outcome: Same as current

Information By: National Cancer Institute, Naples

Dates:
Date Received: June 20, 2012
Date Started: April 2012
Date Completion: June 2018
Last Updated: March 28, 2017
Last Verified: March 2017