eoadjuvant chemotherapy versus standard treatment in patients with locally advanced colon cancer - NeoCol

Vejle Hospital0 个研究点目标入组 250 人开始时间: 2016年6月14日最近更新: 2016年8月29日

适应症

试验速览

暂无简介。

•Histologically verified locally advanced T3 (ETI > 5 mm) or T4 colon cancer assessed by CT scan.
•Age = 18 years
•Hematology
•ANC =1.5x10^9/l. Thrombocytes = 100x10^9/l.
•Biochemistry
•Bilirubinemia = 3 x upper normal level. ALAT = 5 x upper normal value
•Consent to translational research
•Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
•Written and orally informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•Patients with distant metastases.
•Acute operation
•Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before inclusion.
•Active, serious infection or other serious disease.
•Peripheral neuropathy NCI grade > 1
•Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri.
•Other investigational treatment within 30 days prior to treatment start.
•Hypersensitivity to one or more of the active or auxiliary substances.

发起方