Back to resultsFeasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma
Primary Purpose
Locally Advanced and Unresectable, But Non-metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Association of gemcitabine, oxaliplatin and radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced and Unresectable, But Non-metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma
Eligibility 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
Sites / Locations
- Erasme University Hospital
- Jules Bordet Institute
- University Hospital Ghent
- CHU Sart-Tilman
Outcomes
Primary Outcome Measures
Feasibility
Tolerance
Secondary Outcome Measures
Full Information
NCT ID
NCT00286013
First Posted
February 1, 2006
Last Updated
December 6, 2022
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00286013
Brief Title
Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma
Official Title
Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2004 (Actual)
Primary Completion Date
May 31, 2006 (Actual)
Study Completion Date
July 22, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced and Unresectable, But Non-metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Association of gemcitabine, oxaliplatin and radiotherapy
Primary Outcome Measure Information:
Title
Feasibility
Title
Tolerance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Peeters, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasme University Hospital
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Jules Bordet Institute
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Luik
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent
Learn more about this trial
Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma
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