Trial Outcomes & Findings for Study Evaluating Biomarkers in Patients With Colorectal Cancer and Native KRAS Treated With Chemotherapy + Cetuximab (NCT NCT01276379)
NCT ID: NCT01276379
Last Updated: 2021-07-02
Results Overview
Measurements according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors). Main techniques: CT-scan. Two groups will be defined based on the score built from the proposed clinical variables and biomarkers. Instead of a binomial distribution, a Log-rank method has been used to calculate the sample size in order to include all the incidents during the follow-up. Expecting a minimum 20% difference (60 vs. 40%) on PFS at 12 months between groups and with the following assumptions: Alpha error (bilateral): 5% Beta error: 20% Results are reported by subgroups to compare outcome measure according to BRAF mutation. All patients belong to same treatment/study arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
221 participants
Primary outcome timeframe
4 years
Results posted on
2021-07-02
Participant Flow
All patients were allocated in the same treatment arm. Some patient characteristics and results may be reported according to the mutational status of the patients despite all patients received the same treatment schedule
Participant milestones
| Measure |
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
|---|---|
|
Overall Study
STARTED
|
221
|
|
Overall Study
COMPLETED
|
181
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
|---|---|
|
Overall Study
Screening failure
|
40
|
Baseline Characteristics
Study Evaluating Biomarkers in Patients With Colorectal Cancer and Native KRAS Treated With Chemotherapy + Cetuximab
Baseline characteristics by cohort
| Measure |
WT BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=161 Participants
Patients with a determination of BRAF status and presence of Wild type (WT) BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
Mutant BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=20 Participants
Patients with a determination of BRAF status and presence of a mutation in the BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
67 Years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
65 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
161 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
161 participants
n=5 Participants
|
20 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
Stage
Stage I
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Stage
Stage II
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Stage
Stage III
|
30 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Stage
Stage IV
|
117 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Primary location
Ascending colon
|
23 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Primary location
Transverse colon
|
12 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Primary location
Descending colon
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Primary location
Sigmoid colon
|
73 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Primary location
Rectum
|
43 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Surgery of the primary tumor
|
91 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Performance Status (PS)
ECOG 0
|
112 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Performance Status (PS)
ECOG 1
|
49 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Number of metastatic organs
1
|
87 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Number of metastatic organs
2
|
58 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Number of metastatic organs
3
|
15 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Number of metastatic organs
4 or higher
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: Evaluable population
Measurements according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors). Main techniques: CT-scan. Two groups will be defined based on the score built from the proposed clinical variables and biomarkers. Instead of a binomial distribution, a Log-rank method has been used to calculate the sample size in order to include all the incidents during the follow-up. Expecting a minimum 20% difference (60 vs. 40%) on PFS at 12 months between groups and with the following assumptions: Alpha error (bilateral): 5% Beta error: 20% Results are reported by subgroups to compare outcome measure according to BRAF mutation. All patients belong to same treatment/study arm.
Outcome measures
| Measure |
WT BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=161 Participants
Patients with a determination of BRAF status and presence of Wild type (WT) BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
Mutant BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=20 Participants
Patients with a determination of BRAF status and presence of a mutation in the BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
|---|---|---|
|
Progression Free Survival
|
11.4 Months
Interval 9.9 to 13.1
|
5.9 Months
Interval 3.3 to 7.8
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Evaluable population
Measured as time in months from start of study treatment to death or lost to follow up. Results are reported by subgroups to compare outcome measure according to BRAF mutation. All patients belong to same treatment/study arm.
Outcome measures
| Measure |
WT BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=161 Participants
Patients with a determination of BRAF status and presence of Wild type (WT) BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
Mutant BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=20 Participants
Patients with a determination of BRAF status and presence of a mutation in the BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
|---|---|---|
|
Overall Survival
|
32.6 Months
Interval 27.5 to 38.8
|
9.3 Months
Interval 5.3 to 22.0
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Evaluable population
Duration of the partial or total response to the treatment. Evaluation and classification according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)
Outcome measures
| Measure |
WT BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=181 Participants
Patients with a determination of BRAF status and presence of Wild type (WT) BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
Mutant BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
Patients with a determination of BRAF status and presence of a mutation in the BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
|---|---|---|
|
Response Duration
|
8.66 Months
Interval 1.16 to 53.49
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Safety population (all patients that received at least one infusion of study treatment)
Frequency and type of adverse events (AEs). AEs were coded according to NCI CTCAE V3.0 and classified by frequency, relatedness to study treatment (related/not related) and severity (Grade). Severity ranges from grade 1 (low intensity) to Grade 5 (max. intensity, death)
Outcome measures
| Measure |
WT BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=218 Participants
Patients with a determination of BRAF status and presence of Wild type (WT) BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
Mutant BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
Patients with a determination of BRAF status and presence of a mutation in the BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
|---|---|---|
|
Frequency of Adverse Events
Any AEs · yes
|
198 Participants
|
—
|
|
Frequency of Adverse Events
Any AEs · no
|
20 Participants
|
—
|
|
Frequency of Adverse Events
Grade 3 or higher AEs · yes
|
138 Participants
|
—
|
|
Frequency of Adverse Events
Grade 3 or higher AEs · no
|
80 Participants
|
—
|
|
Frequency of Adverse Events
Grade 5 AEs · yes
|
5 Participants
|
—
|
|
Frequency of Adverse Events
Grade 5 AEs · no
|
213 Participants
|
—
|
|
Frequency of Adverse Events
Treatment related AEs of any grade · yes
|
176 Participants
|
—
|
|
Frequency of Adverse Events
Treatment related AEs of any grade · no
|
42 Participants
|
—
|
|
Frequency of Adverse Events
Treatment related AEs grade 3 or higher · yes
|
101 Participants
|
—
|
|
Frequency of Adverse Events
Treatment related AEs grade 3 or higher · no
|
117 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Evaluable population
The secondary biomarkers in serum and tumoral tissue will be analysed in order to predict the acquired resistance.
Outcome measures
| Measure |
WT BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=181 Participants
Patients with a determination of BRAF status and presence of Wild type (WT) BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
Mutant BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
Patients with a determination of BRAF status and presence of a mutation in the BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
|---|---|---|
|
Secondary Biomarkers Analysis
PI3K and PTEN · Mutant
|
98 Participants
|
—
|
|
Secondary Biomarkers Analysis
PI3K and PTEN · UK
|
14 Participants
|
—
|
|
Secondary Biomarkers Analysis
IGF-1RP/MMP7 · WT
|
158 Participants
|
—
|
|
Secondary Biomarkers Analysis
IGF-1RP/MMP7 · Mutant
|
23 Participants
|
—
|
|
Secondary Biomarkers Analysis
IGF-1RP/MMP7 · UK
|
0 Participants
|
—
|
|
Secondary Biomarkers Analysis
PI3K and PTEN · WT
|
69 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Evaluable population
Measurements according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors). Main techniques: CT-scan. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR Results are reported by subgroups to compare outcome measure according to BRAF mutation. All patients belong to same treatment/study arm.
Outcome measures
| Measure |
WT BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=161 Participants
Patients with a determination of BRAF status and presence of Wild type (WT) BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
Mutant BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=20 Participants
Patients with a determination of BRAF status and presence of a mutation in the BRAF gen.
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
|---|---|---|
|
Tumoral Response
Complete response (CR)
|
16 Participants
|
1 Participants
|
|
Tumoral Response
Partial response (PR)
|
106 Participants
|
6 Participants
|
|
Tumoral Response
Stable disease (SD)
|
25 Participants
|
6 Participants
|
|
Tumoral Response
Progression disease (PD)
|
8 Participants
|
4 Participants
|
|
Tumoral Response
Not evaluable (NE)
|
6 Participants
|
3 Participants
|
Adverse Events
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
Serious events: 173 serious events
Other events: 198 other events
Deaths: 136 deaths
Serious adverse events
| Measure |
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=218 participants at risk
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.8%
4/218 • Number of events 4 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
4/218 • Number of events 4 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Metabolism and nutrition disorders
Anorexia
|
0.92%
2/218 • Number of events 2 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Ascites
|
0.46%
1/218 • Number of events 1 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
General disorders
Asthenia
|
8.7%
19/218 • Number of events 19 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
28/218 • Number of events 28 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
General disorders
Pain
|
0.92%
2/218 • Number of events 2 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
3/218 • Number of events 3 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
General disorders
Edema
|
0.46%
1/218 • Number of events 1 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Constipation
|
0.92%
2/218 • Number of events 2 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
General disorders
Fever
|
0.46%
1/218 • Number of events 1 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Fistula
|
3.2%
7/218 • Number of events 7 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Hepatobiliary disorders
Hepatic toxicity
|
1.4%
3/218 • Number of events 3 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Infections and infestations
Infections
|
4.1%
9/218 • Number of events 9 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Blood and lymphatic system disorders
Leucocytopenia
|
1.8%
4/218 • Number of events 4 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Mucositis
|
6.4%
14/218 • Number of events 14 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Nausea
|
4.1%
9/218 • Number of events 9 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Nervous system disorders
Neuropathy
|
2.3%
5/218 • Number of events 5 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.3%
53/218 • Number of events 53 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
5/218 • Number of events 5 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Intestinal obstruction
|
4.6%
10/218 • Number of events 10 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Eye disorders
Ocular alterations non otherwise specified (NOS)
|
0.46%
1/218 • Number of events 1 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Nervous system disorders
paresthesia
|
2.3%
5/218 • Number of events 5 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
3/218 • Number of events 3 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Immune system disorders
Alergic reaction
|
3.2%
7/218 • Number of events 7 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
13.3%
29/218 • Number of events 29 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
rectal bleeding
|
0.46%
1/218 • Number of events 1 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
General disorders
Hand-foot syndrome
|
0.46%
1/218 • Number of events 1 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Hepatobiliary disorders
Transaminitis
|
0.92%
2/218 • Number of events 2 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Cardiac disorders
Cardiac disorders NOS
|
0.92%
2/218 • Number of events 2 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Metabolism and nutrition disorders
Metabolic disorders NOS
|
2.8%
6/218 • Number of events 6 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Gastrointestinal disorders NOS
|
2.3%
5/218 • Number of events 5 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
General disorders
General and site reactions NOS
|
0.92%
2/218 • Number of events 2 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Musculoskeletal and connective tissue disorders
Muscolosqueletal disorders NOS
|
2.3%
5/218 • Number of events 5 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Eye disorders
Ocular disorders NOS
|
1.4%
3/218 • Number of events 3 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Renal and urinary disorders
Urinary disorders NOS
|
1.8%
4/218 • Number of events 4 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders NOS
|
2.8%
6/218 • Number of events 6 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Vascular disorders
Vascular disorders NOS
|
4.6%
10/218 • Number of events 10 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Skin and subcutaneous tissue disorders
Xerosis
|
3.7%
8/218 • Number of events 8 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
Other adverse events
| Measure |
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab
n=218 participants at risk
FOLFOX/FOLFIRI + cetuximab 500mg/m2 bi-weekly for 6 months, then bi-weekly cetuximab as monotherapy.
FOLFIRI (m): FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
FOLFOX-6 (m): FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
* Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
* l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
* One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
* 5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours.
Cetuximab: - 500 mg/m2 i.v. Every 2 weeks.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.3%
29/218 • Number of events 29 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Blood and lymphatic system disorders
Anemia
|
15.6%
34/218 • Number of events 34 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Metabolism and nutrition disorders
Anorexia
|
12.4%
27/218 • Number of events 27 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
General disorders
Asthenia
|
46.3%
101/218 • Number of events 101 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Diarrhoea
|
36.7%
80/218 • Number of events 80 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Nervous system disorders
Dysgeusia
|
10.1%
22/218 • Number of events 22 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
General disorders
Pain NOS
|
9.6%
21/218 • Number of events 21 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Abdominal pain
|
12.8%
28/218 • Number of events 28 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Constipation
|
18.3%
40/218 • Number of events 40 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
General disorders
Fever
|
11.5%
25/218 • Number of events 25 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Fistula
|
21.6%
47/218 • Number of events 47 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Infections and infestations
Infections NOS
|
7.8%
17/218 • Number of events 17 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Blood and lymphatic system disorders
Leucopenia
|
7.3%
16/218 • Number of events 16 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Mucositis
|
39.9%
87/218 • Number of events 87 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Nausea
|
27.5%
60/218 • Number of events 60 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Nervous system disorders
Neuropathy
|
33.0%
72/218 • Number of events 72 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.0%
37/218 • Number of events 37 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Nervous system disorders
Paresthesia
|
20.6%
45/218 • Number of events 45 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.1%
22/218 • Number of events 22 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Skin and subcutaneous tissue disorders
Cutaneous reaction
|
61.5%
134/218 • Number of events 134 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
Mucosa dryness
|
6.0%
13/218 • Number of events 13 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Hepatobiliary disorders
Transaminitis
|
6.0%
13/218 • Number of events 13 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Metabolism and nutrition disorders
Metabolic disorders NOS
|
16.5%
36/218 • Number of events 36 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Gastrointestinal disorders
gastrointestinal disorders
|
18.3%
40/218 • Number of events 40 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorders NOS
|
9.2%
20/218 • Number of events 20 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Eye disorders
Ocular disorders NOS
|
11.0%
24/218 • Number of events 24 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Psychiatric disorders
Psychiatric disorders NOS
|
5.5%
12/218 • Number of events 12 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Renal and urinary disorders
Urinary disorders NOS
|
6.0%
13/218 • Number of events 13 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders NOS
|
13.3%
29/218 • Number of events 29 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Vascular disorders
Vascular disorders NOS
|
5.5%
12/218 • Number of events 12 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Congenital, familial and genetic disorders
trichomegaly
|
5.0%
11/218 • Number of events 11 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
|
Skin and subcutaneous tissue disorders
Xerosis
|
16.5%
36/218 • Number of events 36 • 4 years
Safety assessments included patient history and physical examinations, vital signs, ECOG PS, AEs, blood chemistry, and blood counts, which were performed at each visit. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Relation to cetuximab or chemotherapy (definitely, probably, possibly, unlikely, or unrelated) were assessed by the PI. AEs reported by treatment arm, which includes all patients
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Complying with the R.D. 223/2004, the results of this trial will be published, both positive and negative results in recognized scientific journals or congress. The Sponsor and the Investigators are fully committed to publishing the results of the study. All publications (i.e., manuscripts, abstracts, oral / slide presentations, book chapters) based on this study must be submitted to the sponsor for review prior to publication.
- Publication restrictions are in place
Restriction type: OTHER