Locally advanced non resectable pancreatic cancer MedDRA version: 21.0 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Numb
Sponsors
Dekan of the Medical Faculty of the University Erlangen-Nuremberg; Prof. Dr. med. Markus F. Neurath
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 830 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 830
Exclusion criteria
Exclusion criteria: • Pregnant or lactating/nursing women • Fertile patients who refuse effective contraception during study treatment • synchron second malignant neoplsam except basal cell carcinoma of the skin and carcinoma is 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 and after Stent implantation according to centre`s practice or after having consulted with PI); cirrhosis of the liver Child B and C • Insufficient bone marrow function: WBC 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evidence of survival benefit for locally advanced, non resectable and non metastatic pancreatic cancer after inductionchemotherapy followed by an additional chemoradiotherapy compared to chemotherapy alone ;Secondary Objective: Not applicable;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: End of follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Tumor-free survival • Rate of local recurrence or local progression • Rate of distant metastasis • Acute and late toxicity of the chemoradiotherapy • Quality of life • Rate of remission • Rate of curative resections (R0) after chemotherapy and chemoradiotherapy ;Timepoint(s) of evaluation of this end point: End of follow up | — |
Countries
Germany
Contacts
Public ContactStudiensekretariat
Universitätsklinikum Erlangen, Strahlenklinik
Outcome results
None listed