COSENSE-1: A feasibility study for using a functional precision medicine platform to select oxaliplatin-based versus irinotecan-based chemotherapy regimens for patients with metastatic colorectal cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- The rate of generating valid tumouroid response reports (valid is defined as a fper patienold-change growth in untreated controls of > 1, registered on day 5, 6, 7 or 8 and normalised with resepect to day 0 or 1): a) t included in the trial and b) per patient with obtained tumour samples, and 2) the time from referral to start of allocated treatment.
研究概览
简要总结
The primary objective of this study is to test the feasibility of incorporating patient-derived tumouroids as clinical decision support in clinical practice.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Obtained written informed consent
- •ECOG performance status 0 or 1
- •Histologically confirmed pMMR/MSS adenocarcinoma originating from the colon or rectum
- •The oxaliplatin-based regimen FOLFOX (+/- antibody) versus the irinotecan-based regimen FOLFIRI (+/- antibody), are evaluated by an experienced physician, independent of inclusion in the trial, to be equally recommended for the participant as standard of care first-line therapy in the treatment of mCRC, following the Norwegian national guideline on the treatment of colorectal cancer
- •Unresectable metastatic disease (not amenable to radical surgery of the cancer disease at the time of study inclusion)
- •Patient has measurable or evaluable disease per RECIST (version 1.1)
- •Patient is eligible for full (100%) chemotherapy doses at first treatment cycle
排除标准
- •Patient is ineligible for full (100%) chemotherapy doses at first treatment cycle
- •Pregnancy or planned pregnancy during the study period, due to the risks of drug treatment to a developing foetus
- •Unresolved toxicities of a previous systemic treatment that, in the opinion of the physician, make the patient unfit for inclusion
- •Inability to understand study procedures and comply with them, or disorder that compromises the patient’s ability to provide informed consent and/or comply with study procedures
- •Partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency
- •Patient has metastatic MMR deficient/MSI adenocarcinoma
- •ECOG performance status 2 or worse
- •Patient is not equally eligible for FOLFOX (+/- antibody) and FOLFIRI (+/- antibody) chemotherapy regimens, according to the Norwegian national guideline on the treatment of colorectal cancer
结局指标
主要结局
The rate of generating valid tumouroid response reports (valid is defined as a fper patienold-change growth in untreated controls of > 1, registered on day 5, 6, 7 or 8 and normalised with resepect to day 0 or 1): a) t included in the trial and b) per patient with obtained tumour samples, and 2) the time from referral to start of allocated treatment.
The rate of generating valid tumouroid response reports (valid is defined as a fper patienold-change growth in untreated controls of > 1, registered on day 5, 6, 7 or 8 and normalised with resepect to day 0 or 1): a) t included in the trial and b) per patient with obtained tumour samples, and 2) the time from referral to start of allocated treatment.
What is the time from referral to start of allocated treatment
What is the time from referral to start of allocated treatment
次要结局
- Response Rates (RR) including ORR, according to RECIST v1.1. criteria
- Overall Survival (OS)
- Progression Free Survival (PFS), defined as the time from starting first-line treatment to the time of documentation of PD according to RECIST on active therapy, determined failure of treatment strategy or death
- Progression Free Survival Rate at 6 months
- Disease Control Rate (DCR) assessed with RECIST v1.1
- Clinical Benefit Rate (CBR), defined as the percentage of patients who had a complete response, partial response, or had stable disease for 6 months or more
- Toxicity graded with the CTCAE v.5.0: incidence of grade 3-5 adverse events
研究者
Cancer clinic
Scientific
St. Olavs Hospital HF