Anti-EGFR Agents in Patients With Right-sided Advanced Colorectal Cancer With Wild-type RAS and AREG/EREG High Status

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT07094893
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cetuximab (EGFR inhibitor) — DRUG
    Administration according to the labels of each IMP.
  • Bevacizumab — DRUG
    Administration according to the labels of each IMP.
  • Irinotecan (CPT-11) — DRUG
    Administration according to the labels of each IMP.
  • Oxaliplatin — DRUG
    Administration according to the labels of each IMP.
  • Leucovorin and 5-FU — DRUG
    Administration according to the labels of each IMP.
  • Capecitabine — DRUG
    Administration according to the labels of each IMP.

Study Details

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.

Key Dates

Start date
Apr 15, 2026
Status verified
Jan 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2030

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Doublet or Triplet +/- Bevacizumab
    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.
  • Experimental: Doublet + Cetuximab
    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.

Primary Outcome Measure

Early tumour shrinkage (ETS) [ Time Frame: 8 weeks after treatment start ]

Central Contacts

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