Previously Untreated Metastatic Colorectal Cancer
Conditions
Keywords
Cancer, Colorectal, Metastatic, Untreated
Brief summary
This is an exploratory study to compare activity and safety in 400 patients with previously untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)
Interventions
DRUGUFOX + Cetuximab
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22) * Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks) * Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21 * Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
DRUGFOLFOX4 + Cetuximab
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22) * Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks) * 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16 * Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent * Inpatient or outpatient ≥ 18 years of age * Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * First occurrence of metastatic disease (not curatively resectable) * Presence of at least one lesion measurable uni dimensionally by computerised tomography (CT) scan or magnetic resonance imaging (MRI). (Target lesion(s) must not lie within an irradiated area) * Life expectancy of ≥ 3 months * Karnofsky performance status of ≥ 60, at study entry * White blood cell count (WBC) ≥ 3 x 10\^9/L, with neutrophils ≥ 1.5 x 10\^9/L, platelets ≥ 100 x 10\^9/L, and hemoglobin ≥ 9 g/dL * Aspartate transaminase and alanine transaminase ≤ 2.5 x Upper Limit of Normal (ULN) (≤ 5 x ULN if liver metastasis are present) * Normal serum creatinine (in case of elevated creatinine, labelled ethylenediaminetetraacetic acid clearance ≥ 65 mL/min is acceptable) * Effective contraception for both male and female subjects if the risk of conception exists * Tumor biopsy or archived sample available
Exclusion criteria
* Brain metastasis and/or leptomeningeal disease (known or suspected) * Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment. * Previous oxaliplatin-based chemotherapy * Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization * Concurrent or previous chronic systemic immune therapy, targeted therapy, anti-vascular epithelial growth factor (VEGF) therapy, epidermal growth factor receptor (EGFR) pathway targeting therapy not indicated in the study protocol * Concurrent hormonal therapy not indicated in the study protocol except for physiologic replacement or contraception * Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia * Peripheral neuropathy \>grade 1 * Known hypersensitivity reaction to any of the components of the treatment. * Any concurrent malignancy other than basal cell cancer of the skin, or pre-invasive cancer of the cervix. (Subjects with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the study) * Pregnancy (absence to be confirmed by ß-human chorionic gonadotrophin test) or lactation period * Known drug abuse/alcohol abuse * Legal incapacity or limited legal capacity * Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent * Participation in another clinical study within the 30 days before randomization * Significant disease which, in the investigator's opinion, would exclude the subject from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009 | Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009 | Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. |
| Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C) | At baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. Cycles were 4 weeks long unless dosing delays | All of the single-item measures of the FACT-C are assessed on ordinal response categories ranging from 0=Not at all to 4=Very much. For scoring purposes the response scores are reversed on negatively phrased questions. The principle for scoring the sub-scales is the same in all cases: subscale score = (Sum of items × Number of items in the subscale) / numbers of items answered. The lowest possible total score is 0 and the highest is 136. A high scale score represents a high QOL. |
| QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire | at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays | The EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QOL. |
| Best Overall Response (BOR) | Evaluations were performed every 8 weeks until disease progression, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009 | BOR defined as percentage of subjects, whose BOR was either (confirmed) complete response (CR) or partial response (PR), relative to the number of subjects belonging to the study population of interest. CR defined as Disappearance of all target lesions plus disappearance of all non-target lesions & without appearance of any new lesions; confirmed minimum 4 weeks later. PR defined as At least 30% reduction in the SOLD of target lesions plus no significant change in non-target lesions to qualify for either CR or PD without appearance of new lesions; confirmed minimum 4 weeks later |
| Treatment Impact on Social Daily Living and Health Care Resource Utilization | From randomisation until final visit, reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009 | Non-protocol medical care visits and consultations |
| Safety - Number of Patients Experiencing Any Adverse Event | Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009 | Please refer to Adverse Events section for details of individual serious adverse events and other adverse events |
| QOL Therapy Preference Questionnaire (TPQ) | at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays | TPQ was used to investigate which features of chemotherapy treatment are the most relevant in ensuring patient satisfaction. The most essential characteristics of a cancer medication are shown at baseline and at cycle 3, along with percentage of subjects selecting that characteristic. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, France, Germany, Greece, Hong Kong, Israel, Italy, Mexico, Poland, Thailand
Participant flow
Recruitment details
First subject randomised 12 February 2007, last subject randomised 30 June 2008. Cut off date was 30th June 2009
Pre-assignment details
A total of 329 participants were screened and 302 participants were included in the Intent to Treat (ITT) Population. One patient included in the ITT population received no study medication and was not included in the Safety Population which comprised 301 participants (151 received UFOX plus cetuximab and 150 FOLFOX4 plus cetuximab).
Participants by arm
| Arm | Count |
|---|---|
| UFOX + Cetuximab UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21 | 152 |
| FOLFOX4 + Cetuximab FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16 | 150 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subject in survival follow-up | 1 | 0 |
| Overall Study | Subject on treatment | 1 | 0 |
Baseline characteristics
| Characteristic | UFOX + Cetuximab | FOLFOX4 + Cetuximab | Total |
|---|---|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 10.01 | 61 years STANDARD_DEVIATION 11.04 | 60.5 years STANDARD_DEVIATION 10.53 |
| Age, Customized <65 years | 93 participants | 84 participants | 177 participants |
| Age, Customized >=65 years | 57 participants | 66 participants | 123 participants |
| Age, Customized Missing | 2 participants | 0 participants | 2 participants |
| Region of Enrollment Argentina | 5 participants | 6 participants | 11 participants |
| Region of Enrollment Australia | 6 participants | 5 participants | 11 participants |
| Region of Enrollment Austria | 13 participants | 9 participants | 22 participants |
| Region of Enrollment Belgium | 5 participants | 7 participants | 12 participants |
| Region of Enrollment Brazil | 5 participants | 9 participants | 14 participants |
| Region of Enrollment France | 6 participants | 8 participants | 14 participants |
| Region of Enrollment Germany | 27 participants | 28 participants | 55 participants |
| Region of Enrollment Greece | 9 participants | 5 participants | 14 participants |
| Region of Enrollment Hong Kong | 7 participants | 4 participants | 11 participants |
| Region of Enrollment Italy | 28 participants | 33 participants | 61 participants |
| Region of Enrollment Mexico | 4 participants | 0 participants | 4 participants |
| Region of Enrollment Poland | 30 participants | 27 participants | 57 participants |
| Region of Enrollment Thailand | 7 participants | 9 participants | 16 participants |
| Sex: Female, Male Female | 57 Participants | 55 Participants | 112 Participants |
| Sex: Female, Male Male | 95 Participants | 95 Participants | 190 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 151 / 151 | 146 / 150 |
| serious Total, serious adverse events | 52 / 151 | 48 / 150 |
Outcome results
Primary
Progression-free Survival (PFS)
Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria
Time frame: Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
Population: Intention-to-treat (ITT) population i.e. all randomized subjects .
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UFOX + Cetuximab | Progression-free Survival (PFS) | 6.6 months |
| FOLFOX4 + Cetuximab | Progression-free Survival (PFS) | 8.2 months |
p-value: 0.004895% CI: [0.515, 0.889]Stratified log rank
Secondary
Best Overall Response (BOR)
BOR defined as percentage of subjects, whose BOR was either (confirmed) complete response (CR) or partial response (PR), relative to the number of subjects belonging to the study population of interest. CR defined as Disappearance of all target lesions plus disappearance of all non-target lesions & without appearance of any new lesions; confirmed minimum 4 weeks later. PR defined as At least 30% reduction in the SOLD of target lesions plus no significant change in non-target lesions to qualify for either CR or PD without appearance of new lesions; confirmed minimum 4 weeks later
Time frame: Evaluations were performed every 8 weeks until disease progression, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
Population: ITT population i.e. all randomized subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UFOX + Cetuximab | Best Overall Response (BOR) | 37.5 percentage of participants |
| FOLFOX4 + Cetuximab | Best Overall Response (BOR) | 51.3 percentage of participants |
p-value: 0.01695% CI: [1.11, 2.777]Cochran-Mantel-Haenszel
Secondary
Overall Survival (OS)
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Time frame: Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
Population: ITT population i.e. all randomized subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UFOX + Cetuximab | Overall Survival (OS) | 12.9 months |
| FOLFOX4 + Cetuximab | Overall Survival (OS) | 15.5 months |
p-value: 0.379795% CI: [0.603, 1.213]Stratified log rank
Secondary
Overall Survival (OS)
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Time frame: Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 31 Aug 2011
Population: ITT population i.e. all randomized subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UFOX + Cetuximab | Overall Survival (OS) | 16.8 months |
| FOLFOX4 + Cetuximab | Overall Survival (OS) | 18.4 months |
p-value: 0.857595% CI: [0.755, 1.263]Stratified log rank
Secondary
QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire
The EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QOL.
Time frame: at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays
Population: Patients were considered evaluable for EQ-5D provided they had at least one evaluable EQ-5D questionnaire and provided that they were also included in the ITT Population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| UFOX + Cetuximab | QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire | Baseline | 0.747 scores on a scale | Standard Error 0.021 |
| UFOX + Cetuximab | QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire | Cycle 3 | 0.782 scores on a scale | Standard Error 0.021 |
| UFOX + Cetuximab | QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire | Cycle 6 | 0.758 scores on a scale | Standard Error 0.026 |
| FOLFOX4 + Cetuximab | QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire | Baseline | 0.734 scores on a scale | Standard Error 0.021 |
| FOLFOX4 + Cetuximab | QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire | Cycle 3 | 0.758 scores on a scale | Standard Error 0.022 |
| FOLFOX4 + Cetuximab | QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire | Cycle 6 | 0.771 scores on a scale | Standard Error 0.026 |
Secondary
QOL Therapy Preference Questionnaire (TPQ)
TPQ was used to investigate which features of chemotherapy treatment are the most relevant in ensuring patient satisfaction. The most essential characteristics of a cancer medication are shown at baseline and at cycle 3, along with percentage of subjects selecting that characteristic.
Time frame: at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays
Population: Patients were considered evaluable for TPQ provided they had at least one evaluable TPQ questionnaire and they were also included in the ITT TPQ subset population.~The most essential characteristics of a cancer medication score are shown at baseline and cycle 3, no further cycles are available due to the low number of patients in later cycles
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UFOX + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Baseline: Does not increase your risk of infection | 18 percentage of participants |
| UFOX + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Baseline: Does not interfere with daily activities | 17 percentage of participants |
| UFOX + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Baseline: Does not make you vomit | 4 percentage of participants |
| UFOX + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Baseline: Does not give you diarrhea | 9 percentage of participants |
| UFOX + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Cycle 3: Does not increase your risk of infection | 15 percentage of participants |
| UFOX + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Cycle 3: Does not interfere with daily activities | 10 percentage of participants |
| UFOX + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Cycle 3: Does not make you vomit | 4 percentage of participants |
| UFOX + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Cycle 3: Does not give you diarrhea | 15 percentage of participants |
| FOLFOX4 + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Cycle 3: Does not give you diarrhea | 4 percentage of participants |
| FOLFOX4 + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Baseline: Does not increase your risk of infection | 16 percentage of participants |
| FOLFOX4 + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Cycle 3: Does not increase your risk of infection | 15 percentage of participants |
| FOLFOX4 + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Baseline: Does not interfere with daily activities | 15 percentage of participants |
| FOLFOX4 + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Cycle 3: Does not make you vomit | 10 percentage of participants |
| FOLFOX4 + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Baseline: Does not make you vomit | 14 percentage of participants |
| FOLFOX4 + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Cycle 3: Does not interfere with daily activities | 11 percentage of participants |
| FOLFOX4 + Cetuximab | QOL Therapy Preference Questionnaire (TPQ) | Baseline: Does not give you diarrhea | 5 percentage of participants |
Secondary
Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
All of the single-item measures of the FACT-C are assessed on ordinal response categories ranging from 0=Not at all to 4=Very much. For scoring purposes the response scores are reversed on negatively phrased questions. The principle for scoring the sub-scales is the same in all cases: subscale score = (Sum of items × Number of items in the subscale) / numbers of items answered. The lowest possible total score is 0 and the highest is 136. A high scale score represents a high QOL.
Time frame: At baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. Cycles were 4 weeks long unless dosing delays
Population: Patients were considered evaluable for FACT-C provided they had at least one evaluable FACT-C questionnaire and provided that they were also included in the ITT Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| UFOX + Cetuximab | Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C) | Baseline | 98.22 scores on a scale | Standard Error 1.725 |
| UFOX + Cetuximab | Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C) | Cycle 3 | 95.41 scores on a scale | Standard Error 1.735 |
| UFOX + Cetuximab | Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C) | Cycle 6 | 94.75 scores on a scale | Standard Error 2.09 |
| FOLFOX4 + Cetuximab | Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C) | Baseline | 96.45 scores on a scale | Standard Error 1.749 |
| FOLFOX4 + Cetuximab | Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C) | Cycle 3 | 95.89 scores on a scale | Standard Error 1.806 |
| FOLFOX4 + Cetuximab | Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C) | Cycle 6 | 94.70 scores on a scale | Standard Error 2.126 |
Secondary
Safety - Number of Patients Experiencing Any Adverse Event
Please refer to Adverse Events section for details of individual serious adverse events and other adverse events
Time frame: Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UFOX + Cetuximab | Safety - Number of Patients Experiencing Any Adverse Event | 151 participants |
| FOLFOX4 + Cetuximab | Safety - Number of Patients Experiencing Any Adverse Event | 149 participants |
Secondary
Treatment Impact on Social Daily Living and Health Care Resource Utilization
Non-protocol medical care visits and consultations
Time frame: From randomisation until final visit, reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UFOX + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | General Practitioner consultation | 65 visits or consultations |
| UFOX + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Emergency room visit | 34 visits or consultations |
| UFOX + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Specialist consultation | 62 visits or consultations |
| UFOX + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Practice visit | 71 visits or consultations |
| UFOX + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Nurse consultation | 15 visits or consultations |
| UFOX + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Hospital oupatient clinic visit | 40 visits or consultations |
| UFOX + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Other consultation | 19 visits or consultations |
| UFOX + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Home visit | 15 visits or consultations |
| FOLFOX4 + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Other consultation | 18 visits or consultations |
| FOLFOX4 + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Emergency room visit | 26 visits or consultations |
| FOLFOX4 + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Hospital oupatient clinic visit | 35 visits or consultations |
| FOLFOX4 + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Practice visit | 159 visits or consultations |
| FOLFOX4 + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | General Practitioner consultation | 124 visits or consultations |
| FOLFOX4 + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Specialist consultation | 84 visits or consultations |
| FOLFOX4 + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Nurse consultation | 123 visits or consultations |
| FOLFOX4 + Cetuximab | Treatment Impact on Social Daily Living and Health Care Resource Utilization | Home visit | 130 visits or consultations |