The influence of micrometastases on prognosis and survival in stage I-II colon cancerpatients: the EnRoute+ study - EnRoute+ study

Jeroen Bosch Ziekenhuis0 个研究点目标入组 1,000 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- 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

•- 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
•- 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

发起方

Jeroen Bosch Ziekenhuis