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


Phase 2
18 Years
N/A
Not Enrolling
Both
Locally Advanced and Unresectable, But Non-Metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility

Principal Investigator

Marc Peeters, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

2004/196

NCT ID:

NCT00286013

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Locally Advanced and Unresectable, But Non-Metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Cholangiocarcinoma

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