OPTIMISE OPTIMIzation of treatment SElection and follow up in oligometastatic colorectal cancer – a ctDNA guided phase II randomized approach

Region Midtjylland0 个研究点目标入组 350 人开始时间: 2023年11月23日最近更新: 2024年7月22日

适应症

试验速览

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•Radical intended treatment for metastatic spread from colorectal cancer, by resection, RFA, SBRT (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), No evidence of further disease based on pre-treatment work-up according to standard of care, Age at least 18 years, ECOG performance status 0-2, Clinically eligible for adjuvant triple CT at investigators decision, Adequate bone marrow, liver and renal function allowing systemic chemotherapy (absolute neutrophil count =1.5x10^9/l and thrombocytes = 100x10^9/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

•Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1, Other malignant tumour within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri, Pregnant (positive pregnancy test) or breast feeding women, Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabin

发起方

Region Midtjylland