Adjuvant Versus Neoadjuvant Plus Adjuvant Chemotherapy in Resectable Pancreatic Cancer

• Status: Terminated
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The outcome of patients with resected pancreatic cancer has significantly been improved by adjuvant chemotherapy. However, a large proportion of patients cannot receive adjuvant chemotherapy due to surgical complications. Neoadjuvant chemotherapy has been shown to be safe and effective and can be applied to all patients. This study should test neoadjuvant chemotherapy in a randomized manner.

Patients with resectable cytologically proven adenocarinoma of the pancreatic head are randomized to arm A or B.

Patients randomized to arm A receive an 8-week neoadjuvant chemotherapy with gemcitabine/oxaliplatin followed by surgery. Thereafter, all patients receive adjuvant gemcitabine for six months.

Patients randomized to arm B undergo surgery and receive the same adjuvant treatment as in arm A.

The primary study-endpoint is the recurrence-free survival. Tumor recurrence are determined by computed tomography in a defined protocol.

• Trial with medicinal product

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Gemcitabine; Oxaliplatin

Criteria

Inclusion criteria:

• resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)

• T1-3, Nx, M0 (UICC 6th version, 2002)

• infiltration of the portal vein (<180°) is not an exclusion criterion

• cytologic or histologic confirmation of adenocarcinoma

• age >18 years

• written informed consent

Exclusion criteria:

• contraindication for Whipple procedure

• an infiltration >180° of the portal vein

• abutment of the tumor to the superior mesenteric artery

• infiltration of the superior mesenteric artery or the celiac trunk

• chronic neuropathy > grade 2

• WHO performance score >2

• uncorrectable cholestasis (bilirubin > 100mmol/l despite drainage attempts for more than four weeks prior to inclusion)

• female patients in child bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessary (IUP), condoms)

• pregnant or lactating women

• mental or organic disorders which could interfere with giving informed consent or receiving treatments

• Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer

• percutaneous biopsy of the primary tumor