Overview

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