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

NCT06509126 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-07-19

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Cancer Stage IV

Interventions

DRUG

Panitumumab

Administered at the dosage of 6mg/kg as 60 minutes, or 90 minutes for doses over 1000 mg, intravenous infusion

DRUG

Irinotecan

Administered at the dosage of 180 mg/m2 over 60 minutes intravenous infusion

DRUG

5-fluorouracil

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

DRUG

L-folinic acid

Administered at the dosage of 200 mg/m2 over 120 minutes as intravenous infusion

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2028-01-31
Completion
2028-06-30

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06509126 on ClinicalTrials.gov