EUCTR2010-021477-36-DEActive, not recruitingPhase 1
Adjuvant chemotherapy versus NEOadjuvant gemcitabine/ oxaliplatin plus adjuvant gemcitabine in resectable PAncreatic Cancer: a randomized multicenter phase III study - NEOPAC
Gesellschaft für Studienmanagement und Onkologie mbH0 sites310 target enrollmentStarted: November 19, 2013Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 310
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 (< 180°) is not an exclusion criterion
- •4.Cytologic or histologic confirmation of adenocarcinoma
- •5.Age > 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
- •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
Investigators
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