EUCTR2016-004394-40-ITActive, not recruitingPhase 1
Randomized phase III study of triplet mFOLFOXIRI plus PANITUMUMAB versus mFOLFOX6 plus PANITUMUMAB as initial therapy for unresectable RAS and BRAF wild-type metastatic colorectal cancer patients - TRIPLETE
Fondazione GONO0 sites432 target enrollmentStarted: September 10, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 432
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Histologically proven diagnosis of colorectal cancer.
- •Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.
- •At least one measurable lesion according to RECIST1.1
- •Availability of a tissue tumour sample (primary tumour and/or metastatic sites)
- •Previous adjuvant chemotherapy allowed only if with fluoropyrimidine monotherapy and more than 6 months elapsed between the end of adjuvant and first relapse.
- •RAS (codons 12, 13, 59, 61, 117 and 146 of KRAS and NRAS genes) and BRAF (V600E mutation) wild type status of primary colorectal cancer or related metastasis (local or central laboratory assessment).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 132
Exclusion Criteria
- •Previous treatment for metastatic disease.
- •Radiotherapy to any site within 4 weeks before the study.
- •Previous adjuvant oxaliplatin-containing chemotherapy.
- •Previous treatment with EGFR inhibitors.
- •Untreated brain metastases or spinal cord compression or primary brain tumours.
- •Symptomatic peripheral neuropathy > 1 grade NCIC-CTG criteria.
- •Diagnosis of interstitial pneumonitis or pulmonary fibrosis.
Investigators
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