colon cancer large intestine cancer
Conditions
Interventions
Detection of micrometastases in pN0 colon cancer patients through ex vivo
sentinel lymph node mapping procedure and fine pathology by serial sectioning
and immunohistochemistry. pN0micro+ patients w
Sponsors
Jeroen Bosch Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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 - patients free of disseminated disease - written informed consent
Exclusion criteria
Exclusion criteria: - previous chemotherapy - high risk pN0 patient according to: less then 10 lymph nodes detected in resected specimen, or invasion in other organs (T4NxMx), or colon perforation at presentation, or obstruction at presentation, or angioinvasion at pathological examination. - clinically positive nodal tumours or advanced disease (stage III / Dukes C) - haematology (within 7 days before start of chemotherapy treatment): Hb = 1,5 UL, ASAT >= 2,5 UL, ALAT >= 2,5 UL, gamma-GT >= 2,5 UL, ALP >= 5 UL, - other current serious illness or medical conditions: severe cardiac illness (NYHA class III-IV) , significant neurologic or psychiatric disorders, uncontrolled infections, active DIC, other serious underlying medical conditions that could impair the ability of the patient to participate in the study - known hypersensitivity to study drugs - definite contraindications for the use of corticosteroids - use of immunosuppressive or antiviral drugs - any other experimental drugs within a 4-week period prior to start of surgery and adjuvant chemotherapy and throughout the study period - pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is 3-year DFS in study groups (proportion of patients without local or distant recurrence, or second primary colorectal cancer, during the defined period of time). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are rate of upstaging in pN0 colonic cancer patients (total number pN0micro+ patients x 100 / total number pN0 colon cancer patients) and 3-year overall survival. | — |
Countries
Netherlands
Outcome results
None listed