Presentation study protocol
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The document outlines the rationale and protocol for a study investigating micrometastases in pN0 colon cancer patients. It notes high recurrence rates in this group and aims to 1) improve risk stratification and 2) study the impact of adjuvant chemotherapy for pN0micro+ patients. The proposed study is a multicenter, randomized clinical trial that will examine lymph nodes from pN0 colon cancer patients using serial sectioning and immunohistochemistry to detect micrometastases, and randomize pN0micro+ patients to observation or adjuvant chemotherapy to evaluate 3-year disease-free survival.
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Presentation study protocol
- 7. RATIONALE OF THE STUDY Medisch Contact 2010
- 8. RATIONALE OF THE STUDY Steenbergen, EJSO 2009
- 9. RATIONALE OF THE STUDY Van der Zaag, EJSO 2009
- 10. RATIONALE OF THE STUDY Van der Zaag, EJSO 2009
- 30. EnRoute PROTOCOL
- 31. RATIONALE OF THE STUDY
- 32. RATIONALE OF THE STUDY Cochrane.org
- 38. EnRoute PROTOCOL STUDY DESIGN flow chart
- 39. EnRoute PROTOCOL PRIMARY END-POINT - 3-year disease free survival (DFS) in study groups (proportion of patients without local or distant recurrence, or second primary colorectal cancer, during the defined period of time)
- 40. EnRoute PROTOCOL INCLUSION CRITERIA Registration - histological proven colon cancer, clinically localized, judged potentially resectable for cure, without intraoperatively gross nodal involvement - radiological suspicion of colon cancer, clinically localized, judged potentially resectable for cure, without intraoperatively gross nodal involvement - written informed consent
- 41. EnRoute PROTOCOL EXCLUSION CRITERIA Registration - age < 18 years - previous colorectal surgery - clinical tumor perforation or obstruction
- 42. EnRoute PROTOCOL INCLUSION CRITERIA Randomization - pN0micro+ colon cancer patients (stage I/II, Dukes A/B) - patients deemed to be fit for chemotherapy treatment (WHO classification ≤ 1; ASA classification ≤ 2)
- 43. EnRoute PROTOCOL EXCLUSION CRITERIA Randomization - high risk pN0 according to: LNN < 10, T4, perforation/obstruction, lymphangioinvasion - chemotherapy-related exclusion criteria
- 44. EnRoute PROTOCOL CONSORT STATEMENT
- 48. EnRoute PROTOCOL FOLLOW UP