Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to evaluate the feasibility defined as overall tolerance and toxicity as well as relative dose-intensity and cumulative dose delivered, of an association ofgemcitabine, oxaliplatin and radiotherapy in patients with locally advanced and unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Treatments: Gemcitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically proven and unresectable adenocarcinoma of the pancreas or cholangiocarcinoma with no evidence of metastatic disease

• WHO performance status of 0 or 1

• Complete recovrey from surgery in case an enteric and/or biliary tract by-pass operation has been performed

• Maximum delay after surgery: 8 weeks

• No previous or co-existent malignant disease except non melanoma skin cancers and adequately treated cervic carcinoma in situ

• Adequate bon marrow reserve

• No previous chemotherapy or radiotherapy

• Expected survival > 6 months

Exclusion Criteria:

• Active infection

• Metastatic disease

• Inadequate liver function after derivative surgery

• Inadequate renal function

• Pregnancy, breast feeding

• Use of any other investigational agent in the month before enrollment

• Patients with grade 2 or more neuropathy