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 Ot
Sponsors
Kohei Shitara
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Investigator* and subinvestigator judge a candidate is understand clinical trial and comply this protocol. *Those who participates in conducting a study and oversight the study duties at a site. (2)Patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment (3)Aged >=20 to = 1.5*10^3/microL 2)Platelet count >= 1.0*10^4/microL 3)Hemoglobin >= 9.0 g/dL 4)Total bilirubin == 3 months (90 days) after enrollment
Exclusion criteria
Exclusion criteria: (1)Radiotherapy received within 4 weeks (28 days) prior to enrollment. Treatments aimed at relieving pain for bone metastases are excluded. (2)Known brain metastasis or strongly suspected of brain metastasis (3)Synchronous cancers or metachronous cancers with a disease-free period of == Grade 2 by CTCAE (Japanese edition JCOG version 4.03) (22)Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study (e.g. Patients who might agree to participate under compulsion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Overall survival (OS) for All Participants Timeframe: Up to approximately 60 months OS will be measured as the time from the date of randomization to the date of death due to any cause. 2.OS for Participants with Left-sided Tumors Timeframe: Up to approximately 60 months OS will be measured as the time from the date of randomization to the date of death due to any cause. The left-sided tumors are defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Progression-Free Survival (PFS) Timeframe: Up to approximately 60 months 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. The outcome will be reported per all participants and those with left-sided tumors. The left-sided tumors are defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum. 2.Response Rate (RR) Timeframe: Approximately 12 months 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. The outcome will be reported per all participants and those with left-sided tumors. The left-sided tumors are defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum. 3.Duration of response (DOR) Time Frame: Up to approximately 60 months 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. The outcome will be reported per all participants and those with left-sided tumors. The left-sided tumors are defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum. 4.Percentage of Participants Treated with Curative Surgical Resection after Chemotherapy Timeframe: Up to approximately 60 months Curative surgical resection is defined as complete resection. The outcome will be reported per all participants and those with left-sided tumors. The left-sided tumors are defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum. 5.Percentage of Participants with Treatment-emergent Adverse Events Timeframe: Until 28 days after the discontinuation of protocol treatment or the start subsequent therapy (up to approxim | — |
Countries
Japan
Outcome results
None listed