Gemcitabine en radiotherapie in combinatie met panitumumab bij patiënten met niet uitgezaaide, inoperabele alvleesklierkanker.

1. Histological or cytological confirmed pancreatic cancer;

2. Not eligible for curative resection;

3. No distant metastases present;

4. Previously untreated with chemotherapy and anti-cancer biologicals for current malignancy;

5. No other current malignant disease, except for basal cell carcinoma of the skin;

6. Measurable or evaluable disease as defined by RECIST 1.1 criteria;

7. Performance status 0–2 Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Scale;

8. Age ≥ 18 years;

9. Adequate haematological and biological functions:

A. Bone marrow function:

i. Neutrophils ≥ 1.5 x 109/L;

ii. Platelets ≥ 100 x 109/L;

iii. Hb ≥ 6 mmol/L.

B. Hepatic function:

i. AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN);

ii. Bilirubin ≤ 1.5 times institutional ULN.

C. Renal function:

i. eGFR >50ml/min.

D. Metabolic Function:

i. Magnesium ≥ lower limit of normal;

ii. Calcium ≥ lower limit of normal.

10. No imminent bowel obstruction;

11. No active bleeding;

12. No uncontrolled infection;

13. Patients with reproductive potential must use effective contraception. Female patients must have a negative pregnancy test;

14. Signed informed consent.

1. Participation in another therapeutic clinical study within 30 days of enrollment or during this clinical study;

2. No adequate radiation therapy possible: based on the opinion of the radiation oncologist when radiation therapy cannot be performed because radiation field is too large (PTV volume too large or OAR too high);

3. History of allergic reactions to gemcitabine or antibody treatment;

4. Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection, uncontrolled hypertension);

5. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 1 year before enrolment/randomization;

6. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan;

7. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance;

8. Pregnant or breastfeeding women;

9. Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for six months after last treatment;

10. Known positive status for HIV and/or hepatitis B or C;

11. Any reason why, in the investigator’s opinion, the patient should not participate in the study;

12. Drug or alcohol abuse.