Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Per Pfeiffer
With
Merck Serono International SA
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histology and stages:
Histologically 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
You may not be if
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
