MSS/pMMR metastatic colorectal cancer
Conditions
Brief summary
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
Detailed description
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
Interventions
DRUGOxaliplatin Fresenius Kabi
DRUGIrinotecan Fresenius Kabi
Sponsors
St. Olavs Hospital HF
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Norway
Outcome results
None listed