Studieninformationen
Kurztitel:
FIRE 4.5
Beschreibung:
Randomised study to investigate FOLFOXIRI plus cetuximab or FOLFOXIRI plus bevacizumab as first-line treatment of BRAF-mutated metastatic colorectal cancer
Studiendesign:
Phase II, , Investigator initiierte Studie (IIT), Peer Reviewed, Monozentrisch, National
Therapielinien:
,
Alter:
>= 20 Jahre
Erkrankungen:
Ein-/Ausschlusskriterien:
Inclusion Criteria: Histologically confirmed colorectal cancer RAS wild-type Measurable lesion by RECIST (Ver.1.1) No past history of chemotherapy in the case of unresectable primary lesion/distant metastasis/lymph node metastasis.In the case of recurrence, no treatment for the first recurrence lesion after operation Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.The case >=71 years is PS0. Life expectancy of more than 6 months Patients have enough organ function for study treatment within 14 days before enrollment; White blood cell (WBC)>=3,000/mm3, <12,000/mm3. Neu>=1,500/mm3. Platelet count (PLT) >=10.0x104/mm3. Hb>=9.0g/dL. Total Bilirubin<=1.5x Upper Limited Normal (ULN) aspartate aminotransferase (AST) <=2.5xULN. alanine aminotransferase (ALT) <=2.5xULN. Creatinine<=1.5xULN. Proteinuria<=1+. prothrombin time-international normalized ratio (PT-INR) <=1.5 Must be able to swallow tablets Written informed consent Exclusion Criteria: Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval Lynch syndrome Brain metastases Infectious disease Interstitial lung disease or pulmonary fibrosis Comorbidity or history of serious heart failure History of thromboembolic events Cerebrovascular disease History of hemoptysis/hematemesis Uncontrolled hypertension (systolic BP>180mmHg, or diastolic BP>100mmHg) Sensory alteration or paresthesia interfering with function Large quantity of pleural, abdominal or cardiac effusion Severe comorbidity (renal failure, liver failure, hypertension, etc) Prior radiotherapy for primary and metastases leision Men/women who are unwilling to avoid pregnancy Women who are pregnant or breastfeeding Women with a positive pregnancy test History of severe allergy HBsAg positive or active viral hepatitis Administration of blood products/ Granulocyte-Colony Stimulating Factor (G-CSF), and blood transfusion within 14 days Surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgery within 28 days Systematic administration of antiplatelet drug or non steroid anti-inflammatory drugs (NSAIDs) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy History of gastrointestinal perforation within 1 year Unhealed traumatic bone fracture Uncontrolled diarrhea History of organ recipient Prior cetuximab/bevacizumab/Irinotecan/Oxaliplatin treatment (Adjuvant therapy by Oxaliplatin is excluded) Administration of atazanavir sulfate Jaundice Ileus or bowel obstruction Clinical diagnosis of Alzheimer's Disease Insulin dependent diabetes Thyroid disease Any other cases who are regarded as inadequate for study enrollment by investigators
NCT-Nummer:
Eudract-Nummer:
Studienaktive Standorte
Klinikum Würzburg Mitte gGmbH (Standort Juliusspital)
Gastroenterologie, Rheumatologie
Rekrutierung läuft
Herr Dr. Markus Schubring
m.schubring@kwm-klinikum.de