EUCTR2010-021477-36-DE
Active, not recruiting
Phase 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 enrollmentNovember 19, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Gesellschaft für Studienmanagement und Onkologie mbH
- Enrollment
- 310
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 (\< 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
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
Outcomes
Primary Outcomes
Not specified
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