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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Locally Advanced and Unresectable, But Non-metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma

Treatments: Drug: Association of gemcitabine, oxaliplatin and radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00286013

2004/196

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)