Colorectal CancerPhase 4ARIEL-ENGICNCT07094893
Anti-EGFR Agents in Patients With Right-sided Advanced Colorectal Cancer With Wild-type RAS and AREG/EREG High Status
A Phase 4 study testing Cetuximab (EGFR inhibitor), Bevacizumab and Irinotecan (CPT-11) in people with Colorectal Cancer, run by Gruppo Oncologico del Nord-Ovest.
Trial summary
The aim of this trial is to assess the feasibility of EREG/AREG assessment as a clinical diagnostic standard, used to guide clinical decision making in right-PTL, RAS-wt aCRC. Further to this, the aim is to determine whether EREG/AREG status identifies right-PTL participants who will benefit from the addition of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cetuximab (EGFR inhibitor), Bevacizumab and Irinotecan (CPT-11)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to Mar 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Biopsy-confirmed adenocarcinoma of the colon with a right primary tumour location
- aCRC defined as either M1 or locally inoperable disease
- Tumour RAS status either wild-type (by local testing) or unknown
- Fit for combination chemotherapy plus anti-EGFR agent
- Sufficient tumour material for EREG/AREG analysis
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- Written informed consent for registration
- Registered in ARIEL-ENGIC
- Local testing confirms tumour RAS-wt status
- ARIEL-ENGIC central testing confirms tumour EREG/AREG high
- Tumour measurable by RECIST v1.1 criteria on CT scan
- Participants have had CT scan within the timeframes stipulated (If there is a contrast reaction, then non-contrast CT with MRI is acceptable, assuming at least one of these modalities shows measurable disease at baseline for ETS evaluation and both modalities are repeated at the trial timepoints at week 8 and 16 and every 8 weeks until disease progression.)
- Pre-randomisation laboratory tests :
- Neutrophils ≥1.5 x109/l and platelet count ≥100 x109/l
- Serum bilirubin ≤ 1.25 x upper limit of normal (ULN), alkaline phosphatase
- 5x ULN, and serum transaminase (either AST or ALT) ≤ 2.5 x ULN
- Estimated creatinine clearance ≥50ml/min (creatinine clearance estimated as per local practice)
- WHO performance status (PS) 0, 1 or 2
- Fit for combination chemotherapy plus anti-EGFR agent
- Life expectancy of at least 12 weeks
- Women of childbearing potential must have a negative blood pregnancy test at the baseline visit.
- Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception
- Written informed consent for randomization.
Who cannot join
- Tumour RAS-mutation present
- Prior chemotherapy for aCRC
- Prior anti-EGFR agent therapy
- Participant has received more than one cycle of chemotherapy since registration
- Participants with history of hypersensitivity to any component of their proposed trial treatment regimen or any of their excipients
- Participants in receipt of live vaccine within four weeks prior to randomisation
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- Participants with a history interstitial pneumonitis/idiopathic lung disease (ILD) or pulmonary fibrosis
- Participants with a history of keratitis, ulcerative keratitis or severe dry eye
- Participants with a history of severe skin reaction which in the clinicians' opinion could be exacerbated by EGFR Mab (cf Steven's Johnson Syndrome)
- Complete dihydropyrimidine dehydrogenase (DPYD) deficiency
- Untreated brain metastases or spinal cord compression or primary brain tumours
- History or evidence upon physical examination of CNS disease unless adequately treated
- Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration
- Clinically significant (e.g. active) cardiovascular disease for example cerebrovascular accidents, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), serious cardiac arrhythmia requiring medication
- Treatment with any investigational drug within 30 days prior to enrolment or 2 investigational agent half-lives (whichever is longer)
- Other co-existing malignancies or malignancies diagnosed within the last 5 years that are likely to have an impact upon survival or treatment delivery
- Known human immunodeficiency virus (HIV)
- Has documented presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to enrolment
- Has a positive hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to enrolment. Note: Participants with a positive HCV antibody test result due to prior resolved disease can be randomised, only if a confirmatory HCV RNA test is obtained - Definite contraindications for the use of corticosteroids and antihistamines as premedication.
- Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies.
- Woman pregnant or lactating or expecting to conceive children within the projected duration of the study through 6 months after the last dose of bevacizumab and/or fluorouracil.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Biomarker Enrichment Trial of Anti-EGFR Agents in Patients With Advanced Colorectal Cancer (aCRC) With Wild-type RAS and Right Primary Tumour Location (Right-PTL).
The aim of this trial is to assess the feasibility of EREG/AREG assessment as a clinical diagnostic standard, used to guide clinical decision making in right-PTL, RAS-wt aCRC. Further to this, the aim is to determine whether EREG/AREG status identifies right-PTL participants who will benefit from the addition of anti-EGFR therapy to first-line chemotherapy.
Read the detailed description
ARIEL-ENGIC is a multi-centre, phase IV, open label, randomised controlled biomarker enrichment trial with an internal pilot phase in which participants with wild-type RAS, right-PTL and EREG/AREG high aCRC will be randomized in a 1:1 ratio to receive chemotherapy (doublet) plus cetuximab versus chemotherapy (doublet or triplet) alone or with bevacizumab.
ARIEL-ENGIC is an international trial in which the UK (recruitment ongoing) and EU (Italy, Germany and Spain) are participating. ARIEL-ENGIC aims to randomize 280 participants at a global level. In Europe 60 centers will be involved and 120 participants (40 pts per Member State involved) will be randomized.
Given the biomarker prevalence, 660 participants will be registered to identify sufficient RAS-wt participants with high tumour EREG/AREG expression.
The ARIEL-ENGIC study has 2 phases, registration and randomization (the main trial). Participants meeting all of the inclusion criteria and none of the exclusion criteria for registration will be considered for trial eligibility and biomarker analysis. Tumour samples will be sent for centralized biomarker (EREG/AREG) assessment. Participants with high tumour EREG/AREG will be eligible for randomisation. Participants eligible for the randomisation phase will be allocated 1:1 to chemotherapy alone or with bevacizumab or chemotherapy plus anti-EGFR agent.
Stratification factors will be:
- Choice of first-line chemotherapy (irinotecan-based doublet; oxaliplatin-based doublet; FOLFOXIRI)
- Tumour location (transverse vs caecum vs ascending)
- Prior adjuvant or neoadjuvant chemotherapy (yes vs no)
- Primary tumour resected
- Country of registration
- Conditions
- Colorectal Cancer
- Being tested
- Cetuximab (EGFR inhibitor), Bevacizumab, Irinotecan (CPT-11), Oxaliplatin, Leucovorin and 5-FU
- Keywords
- metastatic colorectal cancer, first-line, right primary tumour location, AREG, EREG, RAS wild-type, anti-EGFR
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab (EGFR inhibitor)Drug
Administration according to the labels of each IMP.
BevacizumabDrug
Administration according to the labels of each IMP.
Irinotecan (CPT-11)Drug
Administration according to the labels of each IMP.
OxaliplatinDrug
Administration according to the labels of each IMP.
Leucovorin and 5-FUDrug
Administration according to the labels of each IMP.
CapecitabineDrug
Administration according to the labels of each IMP.
| Study group | Role | What they receive |
|---|---|---|
| Doublet or Triplet +/- Bevacizumab | Active comparator | FOLFOX or CAPOX or FOLFIRI or FOLFOXIRI +/- bevacizumab.
Treatment regimen and the dosage of each product in both arms will be at Investigators' discretion and in accordance with European guidelines (ESMO).
Chemotherapy backbone is at investigators' choice as per clinical practice and guidelines according to the labels of each IMP. Choice of regimen will depend upon individual patient characteristics and choices, as judged by their oncologist. The choice of adding or not bevacizumab will be at investigators' evaluation according to its label and after evaluating any contraindication to its administration. The study treatment consists of the first 16 weeks of 1st line induction chemotherapy, followed by continuation of chemotherapy +/- bevacizumab, maintenance treatment or treatment break as per investigator and patient preference. Receives: Drug: Bevacizumab; Drug: Irinotecan (CPT-11); Drug: Oxaliplatin; Drug: Leucovorin and 5-FU; Drug: Capecitabine |
| Doublet + Cetuximab | Experimental | FOLFOX or FOLFIRI + Cetuximab.
Treatment regimen and the dosage of each product in both arms will be at Investigators' discretion and in accordance with European guidelines (ESMO).
Chemotherapy backbone is at investigators' choice as per clinical practice and guidelines according to the labels of each IMP. The study treatment consists of the first 16 weeks of 1st line induction chemotherapy, followed by continuation of chemotherapy + cetuximab, maintenance treatment or treatment break as per investigator and patient preference. Receives: Drug: Cetuximab (EGFR inhibitor); Drug: Irinotecan (CPT-11); Drug: Oxaliplatin; Drug: Leucovorin and 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early tumour shrinkage (ETS)
To determine whether first-line chemotherapy (doublet) with cetuximab is more effective than chemotherapy (doublet or triplet) with or without bevacizumab in achieving early tumour shrinkage (ETS) after 8 weeks of treatment in randomised patients.
Measured: 8 weeks after treatment start
Overall survival (OS)
To assess whether the effectiveness of first-line chemotherapy (doublet) with cetuximab is more effective than chemotherapy (doublet or triplet) with or without bevacizumab in terms of overall survival (OS).
Measured: 50 months
Secondary outcomes (9)
Depth of response (DpR)
Depth of response (DpR) is defined as the maximum tumour shrinkage of RECIST target lesions at the nadir, in the absence of new lesions or progression of non-target lesions, when compared with baseline, assessed at 16 weeks from start of treatment.
Measured: 24 months
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the percentage of participants, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria, during the study treatment. The determination of clinical response will be based on investigator reported measurements. Responses will be evaluated every 8 weeks.
Measured: 24 months
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from randomization to the first documentation of objective disease progression or death due to any cause, whichever occurs first. PFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of progressive disease for participants who are alive, on study and progression free at the time of the analysis. Alive participants who have no tumor assessments after baseline will have time to event censored on the date of randomization.
Measured: 24 months
Overall Toxicity Rate
Overall Toxicity Rate is defined as the percentage of participants, relative to the total of enrolled subjects, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during the treatment.
Measured: 24 months
Toxicity Rate
Toxicity Rate is defined as the percentage of participants, relative to the total of enrolled subjects, experiencing a specific adverse event of grade 3 - 4, according to National Cancer Institute Common Toxicity Criteria (version 5.0)3, during the treatment.
Measured: 24 months
Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. Raw scores are standardized and converted into scale scores ranging from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Measured: Questionnaires will be administered at baseline, 8 weeks, 16 weeks, 12- and 24-months post-randomisation.
Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Module for Colorectal cancer 29 (EORTC QLQ-CR29).
The EORTC QLQ-CR29 includes 29 items that evaluate symptoms (gastrointestinal, urinary, pain and others) and functional areas (sexual, body image and others) that are associated with CRC and its treatments. There are separate items for patients with and without a stoma and separate items to evaluate the sexual function of men and women. Raw scores are standardized and converted into scale scores ranging from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Measured: Questionnaires will be administered at baseline, 8 weeks, 16 weeks, 12- and 24- months post-randomisation.
Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life - Additional items to cover anti-EGFR (IL126)
The EORTC IL126 includes 20 items that evaluate additional items to cover anti-EGFR symptomatic toxicity. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Measured: Questionnaires will be administered at baseline, 8 weeks, 16 weeks, 12- and 24- months post-randomisation.
Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life EQ-5D-3L (3-level version of EQ-5D by the EuroQol Group)
The EQ-5D-3L consists of: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Measured: Questionnaires will be administered at baseline, 8 weeks, 16 weeks, 12- and 24- months post-randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start15 Sep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Oncologico del Nord-Ovest
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono International SA
- Responsible party
- Sponsor
- Investigators
- Chiara Cremolini, MD, PhD, Study chair, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094893
- Sponsor's protocol ID
- ARIEL-ENGIC
- Acronym
- ARIEL-ENGIC
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biomarker Enrichment Trial of Anti-EGFR Agents in Patients With Advanced Colorectal Cancer (aCRC) With Wild-type RAS and Right Primary Tumour Location (Right-PTL).
- ClinicalTrials.gov ID
- NCT07094893
- Acronym / sponsor ID
- ARIEL-ENGIC / ARIEL-ENGIC
- Conditions
- Colorectal Cancer
- Keywords
- metastatic colorectal cancer, first-line, right primary tumour location, AREG, EREG, RAS wild-type, anti-EGFR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Gruppo Oncologico del Nord-OvestUniversity, hospital or other
- Collaborators
- Merck Serono International SA
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to assess the feasibility of EREG/AREG assessment as a clinical diagnostic standard, used to guide clinical decision making in right-PTL, RAS-wt aCRC. Further to this, the aim is to determine whether EREG/AREG status identifies right-PTL participants who will benefit from the addition of anti-EGFR therapy to first-line chemotherapy.
Detailed description
ARIEL-ENGIC is a multi-centre, phase IV, open label, randomised controlled biomarker enrichment trial with an internal pilot phase in which participants with wild-type RAS, right-PTL and EREG/AREG high aCRC will be randomized in a 1:1 ratio to receive chemotherapy (doublet) plus cetuximab versus chemotherapy (doublet or triplet) alone or with bevacizumab.
ARIEL-ENGIC is an international trial in which the UK (recruitment ongoing) and EU (Italy, Germany and Spain) are participating. ARIEL-ENGIC aims to randomize 280 participants at a global level. In Europe 60 centers will be involved and 120 participants (40 pts per Member State involved) will be randomized.
Given the biomarker prevalence, 660 participants will be registered to identify sufficient RAS-wt participants with high tumour EREG/AREG expression.
The ARIEL-ENGIC study has 2 phases, registration and randomization (the main trial). Participants meeting all of the inclusion criteria and none of the exclusion criteria for registration will be considered for trial eligibility and biomarker analysis. Tumour samples will be sent for centralized biomarker (EREG/AREG) assessment. Participants with high tumour EREG/AREG will be eligible for randomisation. Participants eligible for the randomisation phase will be allocated 1:1 to chemotherapy alone or with bevacizumab or chemotherapy plus anti-EGFR agent.
Stratification factors will be:
- Choice of first-line chemotherapy (irinotecan-based doublet; oxaliplatin-based doublet; FOLFOXIRI)
- Tumour location (transverse vs caecum vs ascending)
- Prior adjuvant or neoadjuvant chemotherapy (yes vs no)
- Primary tumour resected
- Country of registration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doublet or Triplet +/- Bevacizumab | Active comparator | Drug: Bevacizumab, Drug: Irinotecan (CPT-11), Drug: Oxaliplatin, Drug: Leucovorin and 5-FU, Drug: CapecitabineFOLFOX or CAPOX or FOLFIRI or FOLFOXIRI +/- bevacizumab. Treatment regimen and the dosage of each product in both arms will be at Investigators' discretion and in accordance with European guidelines (ESMO). Chemotherapy backbone is at investigators' choice as per clinical practice and guidelines according to the labels of each IMP. Choice of regimen will depend upon individual patient characteristics and choices, as judged by their oncologist. The choice of adding or not bevacizumab will be at investigators' evaluation according to its label and after evaluating any contraindication to its administration. The study treatment consists of the first 16 weeks of 1st line induction chemotherapy, followed by continuation of chemotherapy +/- bevacizumab, maintenance treatment or treatment break as per investigator and patient preference. |
| Doublet + Cetuximab | Experimental | Drug: Cetuximab (EGFR inhibitor), Drug: Irinotecan (CPT-11), Drug: Oxaliplatin, Drug: Leucovorin and 5-FUFOLFOX or FOLFIRI + Cetuximab. Treatment regimen and the dosage of each product in both arms will be at Investigators' discretion and in accordance with European guidelines (ESMO). Chemotherapy backbone is at investigators' choice as per clinical practice and guidelines according to the labels of each IMP. The study treatment consists of the first 16 weeks of 1st line induction chemotherapy, followed by continuation of chemotherapy + cetuximab, maintenance treatment or treatment break as per investigator and patient preference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age ≥18 years
- Biopsy-confirmed adenocarcinoma of the colon with a right primary tumour location
- aCRC defined as either M1 or locally inoperable disease
- Tumour RAS status either wild-type (by local testing) or unknown
- Fit for combination chemotherapy plus anti-EGFR agent
Key exclusion criteria (21 listed)
- Tumour RAS-mutation present
- Prior chemotherapy for aCRC
- Prior anti-EGFR agent therapy
- Participant has received more than one cycle of chemotherapy since registration
- Participants with history of hypersensitivity to any component of their proposed trial treatment regimen or any of their excipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab (EGFR inhibitor)Administration according to the labels of each IMP. | Drug | Doublet + Cetuximab |
| BevacizumabAdministration according to the labels of each IMP. | Drug | Doublet or Triplet +/- Bevacizumab |
| Irinotecan (CPT-11)Administration according to the labels of each IMP. | Drug | Doublet + Cetuximab, Doublet or Triplet +/- Bevacizumab |
| OxaliplatinAdministration according to the labels of each IMP. | Drug | Doublet + Cetuximab, Doublet or Triplet +/- Bevacizumab |
| Leucovorin and 5-FUAdministration according to the labels of each IMP. | Drug | Doublet + Cetuximab, Doublet or Triplet +/- Bevacizumab |
| CapecitabineAdministration according to the labels of each IMP. | Drug | Doublet or Triplet +/- Bevacizumab |
Primary outcome
Early tumour shrinkage (ETS)
Time frame: 8 weeks after treatment start
To determine whether first-line chemotherapy (doublet) with cetuximab is more effective than chemotherapy (doublet or triplet) with or without bevacizumab in achieving early tumour shrinkage (ETS) after 8 weeks of treatment in randomised patients.
Overall survival (OS)
Time frame: 50 months
To assess whether the effectiveness of first-line chemotherapy (doublet) with cetuximab is more effective than chemotherapy (doublet or triplet) with or without bevacizumab in terms of overall survival (OS).
9 secondary outcomes
Depth of response (DpR)
Time frame: 24 months
Objective Response Rate (ORR)
Time frame: 24 months
Progression-free survival (PFS)
Time frame: 24 months
Overall Toxicity Rate
Time frame: 24 months
Toxicity Rate
Time frame: 24 months
Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Questionnaires will be administered at baseline, 8 weeks, 16 weeks, 12- and 24-months post-randomisation.
Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Module for Colorectal cancer 29 (EORTC QLQ-CR29).
Time frame: Questionnaires will be administered at baseline, 8 weeks, 16 weeks, 12- and 24- months post-randomisation.
Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life - Additional items to cover anti-EGFR (IL126)
Time frame: Questionnaires will be administered at baseline, 8 weeks, 16 weeks, 12- and 24- months post-randomisation.
Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life EQ-5D-3L (3-level version of EQ-5D by the EuroQol Group)
Time frame: Questionnaires will be administered at baseline, 8 weeks, 16 weeks, 12- and 24- months post-randomisation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chiara Cremolini, MD, PhD study chair
Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cetuximab (EGFR inhibitor), Bevacizumab and Irinotecan (CPT-11) in people with Colorectal Cancer, run by Gruppo Oncologico del Nord-Ovest.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Delliponti (+39050992192, laura.delliponti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early tumour shrinkage (ETS) (time frame: 8 weeks after treatment start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.