‘Improving clinical management of colon cancer through CONNECTION, a nation-wide Colon Cancer Registry and Stratification effort.’

MC Utrecht0 个研究点目标入组 260 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•To be eligible to participate in this study, a subject must meet all the following criteria:
•Histologically proven cT3-4, N0-2, M0 primary colon cancer, patients with rectal cancer will be excluded from this study. If there is uncertainty about the origin of the carcinoma (i.e. colon or rectum), it is up to the local treating physician to decide whether the patient is eligible. For tumours located in the rectosigmoid region, the decision of the local multidisciplinary team will determine if a patient is eligible for this study.
•Patient is able and willing to provide written informed consent for the CONNECTION- study
•Informed consent for PLCRC components ‘clinical data’, ‘tissue’ and ‘future studies’
•MSS based on pre-treatment biopsy by IHC
•Fit to undergo neoadjuvant chemotherapy with capecitabine + oxaliplatin and subsequent surgery judged by the primary treating physician
•Adequate bone marrow, liver and renal function
•-absolute neutrophil count (ANC) =1.5 x 109/L
•-platelets =100 x 109/L
•-HB = 5.5 mmol/L
•-Total bilirubin = 1.5 UNL
•-ASAT = 5 x UNL
•-ALAT = 5 x UNL
•-alkaline phosphatase = 5 x UNL
•-creatinine clearance >30 ml/min

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Any other malignant disease within the preceding 5 years apart from non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk <5%
•Colonic obstruction that has not been defunctioned by a stoma
•Pregnant or lactating women

发起方

MC Utrecht