Colorectal cancer
Conditions
Interventions
investigational material(s)
Generic name etc : mFOLFOX6 + panitumumab
INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, panitumumab
Therapeutic category code : 429 Oth
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study
Exclusion criteria
Exclusion criteria: Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| exploratory Overall survival (OS) Timeframe: Up to approximately 63 months OS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study evaluate the relationship between OS and gene mutations. OS will be measured as the time from the date of randomization to the date of death due to any causes. | — |
Secondary
| Measure | Time frame |
|---|---|
| exploratory Progression-Free Survival (PFS) Timeframe: Up to approximately 63 months PFS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations. PFS is defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause. exploratory Response Rate (RR) Timeframe: Approximately 12 months RR obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations. RR is defined as percentage of participants who achieve Complete Response (CR) and Partial Response (PR) as the best overall response per RECIST version 1.1. exploratory Duration of Response (DOR) Time Frame: Up to approximately 63 months DOR obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations. DOR means that the period from the day when either CR or PR is first confirmed until the day of documented PD or the day of death due to all causes, whichever occurs earlier. exploratory Percentage of Participants who Proceeded to Surgical Resection Time Frame: Up to approximately 63 months The outcome obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations. exploratory Percentage of Participants with Early Tumor Shrinkage Time Frame: Up to approximately 63 months The outcome obtained in | — |
Countries
Japan
Outcome results
None listed