Adjuvant chemotherapy versus NEOadjuvant gemcitabine/ oxaliplatin plus adjuvant gemcitabine in resectable PAncreatic Cancer: a randomized multicenter phase III study

Phase 1

• Conditions: resectable pancreatic cancer; MedDRA version: 17.1Level: LLTClassification code 10033608Term: Pancreatic cancer resectableSystem Organ Class: 100000004864; MedDRA version: 17.1Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-021477-36-DE
• Lead Sponsor: Gesellschaft für Studienmanagement und Onkologie mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-19
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 310

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified