The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer.
The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer. This study will enroll a total of approximately 800 participants (400 per group). Participants will be randomized to either the mFOLFOX6 + panitumumab arm (Group P) or mFOLFOX6 + bevacizumab arm (Group B) at 1:1 ratio at the time of registration. Group P and Group B treatment regimen shown below should be administered once every two weeks, following dose, schedule and route of administration. Group P; mFOLFOX6 + panitumumab combination therapy, once every two weeks OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg Group B; mFOLFOX6 + bevacizumab combination therapy, once every two weeks OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg This trial is conducted by multicenter and is scheduled for 12 months as whole administration period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
823
oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
OS in Participants With Left-sided Tumors
OS was measured as the time from the date of randomization to the date of death due to any cause. The left-sided tumors were defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum.
Time frame: Up to approximately 60 months
Overall Survival (OS) in All Participants
OS was measured as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 60 months
Progression-Free Survival (PFS) in Participants With Left-sided Tumors
PFS was 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 left-sided tumors were defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum.
Time frame: Up to approximately 60 months
Progression-Free Survival (PFS) in All Participants
PFS was 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.
Time frame: Up to approximately 60 months
Response Rate (RR) in All Participants
RR was defined as number of participants who achieve Complete Response (CR) and Partial Response (PR) as the best overall response per RECIST version 1.1.The best overall response was CR, followed by PR, stable disease (SD), progressive disease (PD), and not evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization., SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
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Unnamed facility
Ichinomiya, Aichi-ken, Japan
Unnamed facility
Komaki, Aichi-ken, Japan
Unnamed facility
Kōnan, Aichi-ken, Japan
Unnamed facility
Nagakute, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Okazaki, Aichi-ken, Japan
Unnamed facility
Toyoake, Aichi-ken, Japan
Unnamed facility
Toyohashi, Aichi-ken, Japan
Unnamed facility
Toyokawa, Aichi-ken, Japan
Unnamed facility
Toyota, Aichi-ken, Japan
...and 145 more locations
Time frame: Up to approximately 60 months
Duration of Response (DOR)
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.
Time frame: Up to approximately 60 months
Number of Participants Treated With Curative Surgical Resection After Chemotherapy
Curative surgical resection was defined as complete resection.
Time frame: Up to approximately 60 months
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred in the treatment period after receiving the protocol treatment.
Time frame: Up to approximately 60 months