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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Suspended
• CT.gov ID: NCT00286013
• Collaborator: (none)
• Enrollment: 30
• Locations: 4
• Patients Per Site: 7.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced and Unresectable, But Non-Metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma	Drug: Association of gemcitabine, oxaliplatin and radiotherapy	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma
• Study Start Date: May 1, 2004

Outcome Measures

Primary Outcome Measures

1. Feasibility []

2. Tolerance []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasme University Hospital	Brussels		Belgium	1000
2	Jules Bordet Institute	Brussels		Belgium	1000
3	University Hospital Ghent	Ghent		Belgium	9000
4	CHU Sart-Tilman	Luik		Belgium	4000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Marc Peeters, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website University Hospital Ghent

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00286013
• Other Study ID Numbers: 2004/196
• First Posted: Feb 2, 2006
• Last Update Posted: Dec 28, 2007
• Last Verified: Dec 1, 2007

• Additional relevant MeSH terms: Cholangiocarcinoma; Gemcitabine; Oxaliplatin

Study Results

No Results Posted as of Dec 28, 2007