Metastatic colorectal cancer with wild-type KRAS and BRAF MedDRA version: 14.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10061451 Term: Colorectal cancer S
Conditions
Interventions
Trade Name: Fluorouracil
Product Name: Fluorouracil
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: FLUOROURACIL
CAS Num
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histology and stagesHistologically proven adenocarcinoma in the colon or rectum - At least 1 measurable metastatic disease manifestation according to the RECIST criteria (version 1.1) - Potentially completely resectable or potentially curable metastatic colorectal cancer as determined by the local MDT conference and that requires tumour shrinkage before resection is possible. The following definitions are indicative: -- 4 or more liver metastases (CRLeM) without extra-hepatic disease -- 2 or more lung metastases (CRLuM) without hepatic or extra-hepatic disease -- 1 or more CRLeM determined as "potentially resectable" (such as because of location) by the local MDT. -- 1 or more CRLuM determined by the local MDT as potentially resectable (such as because of location). -- Non-resectable primary disease with resectable CRLeM or CRLuM. KRAS and BRAF status - Tumour tissue (primary or metastasis) typed as wild-type KRAS AND wild-type BRAF General conditions - age > 18 years - WHO performance status = 1; - expected survival > 3 months - sufficient bone-marrow function (Hb = 6.2 µmol/l/Hb > 10 g/dl ANC = 1.5 x 109/l, thrombocytes = 100 x 109/l) - sufficient kidney and liver function: total bilirubin = 1.5 x upper normal limit, serum creatinine = 1.25 x upper normal limit, ALAT = 3 x upper normal limit and = 5 x upper normal limit with liver metastases - the patient must have signed an informed declaration of consent before being registered; this must be documentable according to national guidelines 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous treatment - previous chemotherapy for advanced/metastatic disease - adjuvant chemotherapy unless completed more than 6 months before registration - previous treatment with oxaliplatin or irinotecan - previous treatment with cetuximab or other treatment for EGFR - History of Inflammatory Bowel disease - Severe or uncontrolled cardiovascular disease, congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias) - Any condition that, according to the treating physician's judgement, could prevent the planned medical/surgical treatment from being carried out responsibly (such as uncontrolled active infection, known hypersensitivity or contra-indication for the planned treatment. - Pregnant or breast-feeding women - Patients of fertile age who do not want to use reliable contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate (RR) estimate by the investigator; Secondary Objective: To evaluate and determine Progression-free survival (PFS). Survival. Treatment safety and toxicity. Frequency of secondary surgical resection (R0 + R1 + R2 resections). Frequency of secondary micro-radical surgical resection (R0 resection). Frequency of other radical local treatment, such as RFA or MWA. ; Primary end point(s): To determine and evaluate response rate (RR) ;Timepoint(s) of evaluation of this end point: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Frequency of surgical resection Progression-free survival (PFS) Survival Treatment safety and toxicity ;Timepoint(s) of evaluation of this end point: 5 years | — |
Countries
Denmark, Sweden
Contacts
Public ContactDepartment of Clinical Oncology
Odense University Hospital
Outcome results
None listed