FOLFOXIRI plus Panitumumab or FOLFOX plus Panitumumab in the treatment of metastatic colorectal cancer.

Phase 1

• Conditions: Metastatic Colorectal Cancer; MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004394-40-IT
• Lead Sponsor: Fondazione GONO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-10
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 432

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified