ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer"

Sponsor
Gruppo Oncologico Italia Meridionale
Study ID
NCT07381764
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Colorectal Cancer (CRC)

Eligibility Criteria

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

Interventions

  • Erbitux (Cetuximab) — DRUG
    This is an anti-EGFR monoclonal antibody administered in combination with chemotherapy. The dose is 500 mg/m2 over 120 minutes
  • Bevacizumab — DRUG
    This is an anti-VEGF monoclonal antibody used as an active comparator in the control arm of the study. The dose is 5 mg/Kg of body weight given once every 2 weeks.
  • Irinotecan — DRUG
    Irinotecan is a cytotoxic chemotherapy agent administered intravenously in combination with cetuximab the dose is 180 mg/m2 over 90 minutes, once every 2 weeks.
  • Trifluridine/tipiracil — DRUG
    Trifluridine/tipiracil is an oral antineoplastic combination administered in combination with bevacizumab as part of the control treatment arm. The dose is 5 mg/ m² twice daily on Days 1 to 5 and Days 8 to 12 on a cycle of 28 days.

Study Details

This study is a phase II, open-label, multicenter clinical trial designed to evaluate two different treatment options for patients with metastatic colorectal cancer whose disease has progressed after standard therapies. The study compares a rechallenge treatment using irinotecan plus cetuximab with the current standard of care, trifluridine/tipiracil plus bevacizumab, as third-line therapy. Patients enrolled in the study are selected based on specific molecular characteristics of their cancer, identified through circulating tumor DNA analysis from a blood sample. The main purpose of the study is to determine whether the rechallenge with irinotecan and cetuximab leads to a higher tumor response rate compared with trifluridine/tipiracil plus bevacizumab. Secondary objectives include evaluating progression-free survival, overall survival, safety, and quality of life. Patients will be randomly assigned to one of the two treatment groups and will receive treatment until disease progression, unacceptable side effects, or withdrawal of consent. Tumor response will be assessed using standard imaging techniques according to RECIST criteria.

Key Dates

Start date
Mar 30, 2026
Status verified
Jan 2026
Primary completion
Mar 30, 2031
Completion
Mar 30, 2031

Study Design

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

Arms

  • Experimental: Experimental: Arm A - Irinotecan + Cetuximab
    This arm is for participants with molecularly selected metastatic colorectal cancer who have progressed after standard first- and second-line therapies and previously achieved clinical benefit from an anti-EGFR-based regimen. Participants randomized to this arm will receive irinotecan in combination with cetuximab as a rechallenge strategy. The objective of this arm is to evaluate the antitumor activity and safety of irinotecan plus cetuximab compared with the control treatment in the third-line setting.
  • Active Comparator: Active Comparator: Arm B - Trifluridine/Tipiracil + Bevacizumab
    This arm is for participants with molecularly selected metastatic colorectal cancer who have progressed after standard first- and second-line therapies. Participants randomized to this arm will receive trifluridine/tipiracil in combination with bevacizumab, which represents the current standard of care in the third-line treatment setting. This arm serves as the control group for comparison with the experimental rechallenge strategy.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From Week 8 through disease progression or end of treatment, up to approximately 24 months. ]

Central Contacts

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