Feasibility Of Radiotherapy And Concomitant Gemcitabine And Oxaliplatin In Locally Advanced Pancreatic Cancer And Distal Cholangiocarcinoma

Study Overview

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

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

N/A

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

DRUG: Association of gemcitabine, oxaliplatin and radiotherapy

2004/196

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-02-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-12-06
First Submitted that Met QC Criteria 2006-02-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-12-09
First Posted (ACTUAL) 2006-02-02	Results First Posted N/A	Last Verified 2022-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Feasibility
Tolerance

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Marc Peeters, MD, PhD, University Hospital, Ghent

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record