NL-OMON36641
Withdrawn
Phase 3
The influence of micrometastases on prognosis and survival in stage I-II colon cancerpatients: the EnRoute+ study - EnRoute+ study
Jeroen Bosch Ziekenhuis0 sites1,000 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- colon cancer
- Sponsor
- Jeroen Bosch Ziekenhuis
- Enrollment
- 1000
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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 \<\= 6,2 mmol/l, WBC \<\= 3,0 x 109/L, platelets \<\= 100 x 109/L
- •\- renal function (within 7 days before start of chemotherapy treatment): creatinine \< 1,25 UL or \< 125 µmol/l; creat.clearance \< 60 ml/min.(Cockcroft\-Gault formula)
- •\- liver function (within 7 days before start of treatment): bilirubin \>\= 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
Outcomes
Primary Outcomes
Not specified
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