NCT06509126 Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer
| NCT ID | NCT06509126 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | National Cancer Institute, Naples |
| Condition | Colorectal Cancer Stage IV |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-06-12 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 500 participants in total. It began in 2024-06-12 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent to study procedures and to correlative studies. 2. Histologically proven left sided mCRC. 3. RAS/BRAF wild-type and pMMR and/or MSS status assessed at local centers according a validated method defined by EMA 4. Disease judged unresectable by the local multidisciplinary team 5. Patient candidate to receive Induction treatment with FOLFIRI plus panitumumab as per standard clinical practice 6. No prior treatments (chemotherapy, radiation or surgery) for mCRC. Surgery for primary CRC tumor before starting treatment is allowed. 7. Either sex aged ≥ 18 8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry. 9. Imaging-documented measurable disease, according to RECIST 1.1 criteria. 10. Known dihydropyrimidine dehydrogenase (DPYD) activity is mandatory. Additional analysis of polymorphisms uridine diphosphate-glycosyltransferase 1 (UGT1A1) enzyme is recommended but not mandatory 11. Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL. 12. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 X ULN. 13. Adequate renal function: serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (calculated according to Cockroft-Gault formula). 14. Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range Exclusion Criteria: 1. Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 2. Prior chemotherapy or any other medical treatment for mCRC (previous adjuvant chemotherapy is allowed if terminated \> 6 months previously). 3. Major surgical intervention within 4 weeks prior to enrollment. 4. Pregnancy and breast-feeding. 5. Any brain metastases. 6. Complete deficiency of activity of dihydropyrimidine dehydrogenase (DPYD) or known UGT1A1 homozygosity. 7. Required dose reduction of 5-fluorouracil in the past for toxicity. 8. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study. 9. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form. 10. Participation in any interventional drug or medical device study within 30 days prior to treatment start. 11. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment. 12. History of interstitial pneumonitis or pulmonary fibrosis. 13. History of corneal perforation or ulceration keratitis
Frequently Asked Questions
Who can join the NCT06509126 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Colorectal Cancer Stage IV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06509126 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 500 participants.
Is NCT06509126 currently recruiting?
Yes, NCT06509126 is actively recruiting participants. Visit ClinicalTrials.gov or contact National Cancer Institute, Naples to inquire about joining.
Where is the NCT06509126 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT06509126 clinical trial?
NCT06509126 is sponsored by National Cancer Institute, Naples. The trial plans to enroll 500 participants.
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