IMPROVE Intervention Trial: Implementing non-invasive circulating tumor DNA analysis to optimize the operative and postoperative treatment for patients with colorectal cancerIMPROVE IT - IMPROVE IT

Aarhus University Hospital0 个研究点目标入组 70 人开始时间: 2018年1月11日最近更新: 2021年3月17日

适应症

试验速览

暂无简介。

•Inclusion criteria
•Surgically removed Adenocarcinoma of the colon or rectum
•Pathologically stage I or II disease, and radical resection
•Detectable ctDNA in two weeks postoperative plasma sample
•No indication for adjuvant chemotherapy according to DCCG guidelines (website)
•Age at least 18 years
•ECOG performance status 0-2
•Clinically eligible for adjuvant chemotherapy at investigators decision.
•Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count =1.5x109/l and thrombocytes = 100x109/l. Bilirubin = 1.5 x upper normal value and alanine aminotransferase = 3 x upper normal value, and Calculated or measured renal glomerular filtration rate at least 30 mL/min)
•Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject’s male partner or hormonal contraceptive are acceptable •
•Written and verbally 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 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 35

•Exclusion criteria
•Radiological evidence of distant metastasis, by CT- chest and abdomen
•Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
•Previous treatment with 5FU or oxaliplatin
•Neuropathy NCI grade > 1
•Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri
•Pregnant (positive pregnancy test) or breast feeding women

发起方

Aarhus University Hospital