Significance of Chemoradiation Following Induction Chemotherapy in Locally Advanced,Unresectable Pancreatic Cancer -a Randomised Phase 3 Trial: Chemoradiation Following Induction Chemotherapy Compared With Chemotherapy Alone
Inclusion Criteria:
- Age > 18 years
- histologically confirmed adenocarcinoma of the pancreas
- no evidence of distant metastasis based on computed tomography of the thorax and
abdomen
- non resectable pancreatic cancer
- no evidence of peritoneal carcinosis
- ECOG-performance status ≤ 2
- signed study-specific consent form prior to therapy
Exclusion Criteria:
- fertile patients who refuse effective contraception during study treatment
- synchron second malignant neoplasm except basal cell carcinoma of the skin and
carcinoma in situ of the cervix after curative therapy
- the Inclusion of patients with prior or concurrent malignancy (≤ 5 years prior to
enrolment in study) must be discussed
- chronic inflammatory disease of the intestine
- known allergic reactions on study medication
- on-treatment participation on other trials
- insufficient liver function: Bilirubin > 2,0 mg/dl; SGOT, SGPT, alkaline phosphatase,
gGT more than 3 times upper limit of normal (after Stent implantation in case of
obstructive jaundice); cirrhosis of the liver Child B and C
- insufficient bone marrow function: WBC < 3,0 x 10^9/l, Platelets > 100 x 10^9/l
- serum creatinine > 1,5 mg/dl, creatinin clearance < 60ml/min (or comparable test)
- preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm
disturbances requiring therapy, myocardial infarction within the past 6 months,
unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA)
class III or IV heart disease
- neurological and/or psychiatric diseases: stroke, dementia, epilepsy, psychosis
- active intractable or uncontrollable infection, HIV-infection
- prior radiotherapy or chemotherapy