resectable pancreatic cancer MedDRA version: 17.1 Level: LLT Classification code 10033608 Term: Pancreatic cancer resectable System Organ Class: 100000004864 MedDRA version: 17.1 Level: LLT Classification code 10033604 Term: Pancreatic cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Gemedac
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Gemcitabine
Other descriptive name: GEMCITABINE HYDROCHLORIDE
Concentration unit: mg/ml milligram(s)/mill
Sponsors
Gesellschaft für Studienmanagement und Onkologie mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy) 2. T1-3, Nx, M0 (UICC 6th version, 2002) 3. Infiltration of the portal vein ( 18 years 6. Written informed consent 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 310 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 310
Exclusion criteria
Exclusion criteria: 1. Contraindication for Whipple procedure 2. Infiltration > 180° of the portal vein 3. Abutment of the tumor to the superior mesenteric artery 4. Infiltration of the superior mesenteric artery or the celiac trunk 5. Chronic neuropathy > grade 2 6. WHO performance score > 2 7. Female patients in child-bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessars (IUP), condoms) 8. Pregnant or lactating women 9. Mental or organic disorders which could interfere with giving informed consent or receiving treatments 10. Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer 11. Percutaneous biopsy of the primary tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy) by comparing progression-free survival (PFS);Secondary Objective: To compare treatment arms with respect to: • Histological response • Overall Survival (OS) • Complication rates after surgery • Feasibility of adjuvant chemotherapy;Primary end point(s): Progression-free Survival;Timepoint(s) of evaluation of this end point: Time from date of consent to progression/recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Histological response 2 Overall Survival (OS) 3 Complication rates after surgery 4 Feasibility of adjuvant chemotherapy;Timepoint(s) of evaluation of this end point: 1 At the time of surgery 2 Time from informed consent to death of patients 3 After surgery to end of treatment 4 After surgery | — |
Countries
Austria, Belgium, France, Germany, Switzerland
Outcome results
None listed