Feasibility of radiotherapy and concomitant gemcitabine and oxaliplatin in locally advanced pancreatic cancer and distal cholangiocarcinoma

Phase 1

• Conditions: Pancreatic cancer or distal cholangiocarcinoma

• Registration Number: EUCTR2004-001126-24-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-20
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

* Histological proven and unresectable adenocarcinoma of the pancreas or cholangiocarcinoma with no evidence of metastatic disease.
* WHO performance status 0-1
* Adequate bone marrow reserve.
* No previous chemotherapy or radiotherapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* Previous or co-existent malignant disease except non melanoma skin cancers and adequately treated cervix carcinoma in situ.
* Active infection.
* Metastatic disease.
* Inadequate renal or liver function.
* Pregnancy.
* Use of any other investigational agent in the month before enrolment into the study.
* Age < 18 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the feasibility defined as overall tolerance and toxicity as well as relative dose-intensity and cumulative dose deliverd, of an assocation of gemcitabine, oxalitplatin and radiotherapy in patients with locally advanced and unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma.;Secondary Objective: Respectability rate and overall survival.;Primary end point(s): Feasibility and tolerance.