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

Aarhus University Hospital/Karen-Lise Garm Spindler0 个研究点目标入组 350 人开始时间: 2020年10月7日最近更新: 2024年2月26日

适应症

试验速览

暂无简介。

•Radical intended treatment for metastatic spread from CRC, by resection, RFA, SBRT (or other experimental local treatment options)
•No evidence of further disease based on pre-treatment work-up according to SOC
•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 CT (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 175
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 175

•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 cer-vi-
•Pregnant (positive pregnancy test) or breast feeding women
•Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabin

发起方

Aarhus University Hospital/Karen-Lise Garm Spindler