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

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 optimi

Trial Details

NCT ID
NCT06509126
Phase
PHASE3
Sponsor
National Cancer Institute, Naples
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Panitumumab
  • Irinotecan
  • 5-fluorouracil
  • L-folinic acid
Locations (sample)
  • Naples, Italy|40.85216,14.26811

Key Eligibility Criteria

  • Written informed consent to study procedures and to correlative studies.
  • Histologically proven left sided mCRC.
  • RAS/BRAF wild-type and pMMR and/or MSS status assessed at local centers according a validated method defined by EMA
  • Disease judged unresectable by the local multidisciplinary team

For full eligibility, visit ClinicalTrials.gov.

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