MMRp/ MSS colon cancer
Conditions
Brief summary
Proportion of participants with major pathological response determined by local assessment with protocol specific training/methods, defined as≤10% RVT., Frequency and severity of treatment emergent AEs, SAEs, imAEs, and AEs leading to death or discontinuation of study intervention.
Detailed description
Proportion of participants for whom primary tumour resection is not excluded by either: o Disease progression precluding surgery. o Treatment related toxicity that results in the participant not being suitable for surgery., Proportion of participants with pathological response determined by local assessment in the following categories: o Complete pathologic response (cPR) (0% RVT) o Major pathological response excluding cPR (>0% & ≤10% RVT) o Partial pathologic response (>10% & ≤50% RVT) o Negligible pathologic response (>50% RVT)
Interventions
DRUGCAPECITABINE ZENTIVA 150 mg
DRUGcomprimé pelliculé
DRUGOxaliplatin Bendalis 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGCapecitabine Zentiva 150 mg filmdragerade tabletter
DRUGJEMPERLI 500 mg concentrate for solution for infusion
Sponsors
Glaxosmithkline Research & Development Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with major pathological response determined by local assessment with protocol specific training/methods, defined as≤10% RVT., Frequency and severity of treatment emergent AEs, SAEs, imAEs, and AEs leading to death or discontinuation of study intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants for whom primary tumour resection is not excluded by either: o Disease progression precluding surgery. o Treatment related toxicity that results in the participant not being suitable for surgery., Proportion of participants with pathological response determined by local assessment in the following categories: o Complete pathologic response (cPR) (0% RVT) o Major pathological response excluding cPR (>0% & ≤10% RVT) o Partial pathologic response (>10% & ≤50% RVT) o Negligible pathologic response (>50% RVT) | — |
Countries
Belgium, Italy, Spain
Outcome results
None listed