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Report for Clinical Trial NCT01437618

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

FOLFOXIRI Plus Bevacizumab as First-line Treatment for BRAF V600E Mutant Metastatic Colorectal Cancer: a Prospective Evaluation

The purpose of this study is to prospectively verify if FOLFOXIRI plus bevacizumab as first-line treatment could be considered a promising approach to improve the outcome of BRAF mutant metastatic colorectal cancer patients

NCT01437618 Metastatic Colorectal Cancer
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine

1 Interventions

Name: FOLFOXIRI plus bevacizumab

Description: BEVACIZUMAB 5 mg/Kg i.v. over 30', day 1 followed by IRINOTECAN 165 mg/sqm i.v. over 1-h, day 1 followed by OXALIPLATIN 85 mg/sqm i.v. over 2-h, day 1 concomitantly with l-LV 200 mg/sqm i.v. over 2-h, day 1 followed by 5-FLUOROURACIL 3200 mg/sqm i.v. 48-h continuous infusion, starting on day 1 Cycles repeated every 2 weeks
Type: Drug
Group Labels: 1

BRAF mutant mCRC


Primary Outcomes

Measure: Progression-Free Survival

Time: About 24-30 months (From treatment initiation to evidence of progression or death from any cause)

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 V600E

FOLFOXIRI Plus Bevacizumab as First-line Treatment for BRAF V600E Mutant Metastatic Colorectal Cancer: a Prospective Evaluation. --- V600E ---

Inclusion Criteria: - Histologically confirmed colorectal adenocarcinoma; - Availability of formalin-fixed paraffin embedded tumor block from primary and/or metastasis; - BRAF V600E mutant status of primary colorectal cancer and/or related metastasis; - Unresectable and measurable metastatic disease according to RECIST criteria; - Male or female, aged > 18 years and < 75 years; - ECOG PS < 2 if aged < 71 years; - ECOG PS = 0 if aged 71-75 years; - Life expectancy of more than 3 months; - Adequate haematological function: ANC ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L, Hb ≥ 9 g/dL; - Adequate liver function: serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and transaminases ≤ 2.5 x ULN (in case of liver metastases ≤ 5 x ULN); - Serum creatinine ≤ 1.5 x ULN; - Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse; - At least 6 weeks from prior extended radiotherapy and 4 weeks from surgery; - Written informed consent to experimental treatment and molecular analyses. --- V600E ---



HPO Nodes


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