Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer

Sponsor
National Cancer Institute, Naples
Study ID
NCT06509126
Phase
PHASE3
Status
Recruiting
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Conditions

  • Colorectal Cancer Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Panitumumab — DRUG
    Administered at the dosage of 6mg/kg as 60 minutes, or 90 minutes for doses over 1000 mg, intravenous infusion
  • Irinotecan — DRUG
    Administered at the dosage of 180 mg/m2 over 60 minutes intravenous infusion
  • 5-fluorouracil — DRUG
    Administered at the dosage of 400 mg/m2 (bolus intravenous infusion) followed by continuous intravenous infusion over 46 hours at the dosage of 2400 mg/m2
  • L-folinic acid — DRUG
    Administered at the dosage of 200 mg/m2 over 120 minutes as intravenous infusion

Study Details

The investigators hypothesize that intermittent first-line Panitumumab plus FOLFIRI is effective in first line as the same regimen given continuously, resulting in a Time to Treatment Failure (TTF) not inferior to that obtained with standard continuous regimen of Panitumumab plus FOLFIRI, in the treatment of metastatic left sided RAS/B-RAF wild-type colorectal cancer patients. Correlative mechanistic studies on tissue and blood samples, liquid biopsies, could identify potential biomarkers of efficacy and help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach with a personalized anti-EGFR treatment strategy.

Key Dates

Start date
Jun 12, 2024
Status verified
Jun 2024
Primary completion
Jan 31, 2028
Completion
Jun 30, 2028

Study Design

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

Arms

  • Active Comparator: CONTINUOUS ARM
    Patients will receive Panitumumab plus FOLFIRI until progressive disease, unacceptable toxicity or informed consent withdrawal
  • Experimental: INTERMITTENT ARM
    Patients will have a treatment free interval until progressive disease (PD), when they will receive up to 8 cycles of Panitumumab plus FOLFIRI. In the presence of complete or partial response, or stable disease, non-progressing patients will undergo again to treatment free interval until PD, when they will restart treatment. Treatment cycling will continue till any PD on treatment.

Primary Outcome Measure

Time to Treatment Failure [ Time Frame: up to 1 year last patients randomized ]

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