Gemcitabine and cisplatin in combination with hyperthermia in patients with locally advanced or metastatic pancreatic cancer as second-line therapy after adjuvant or first-line chemotherapy with Gemcitabine or Gemcitabine combinatio

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864; Combination of standard chemotherapy with Gemcitabine and Cisplatin and regional hyperthermia in patients with locally advanced or metastatic pancreatic cancer.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-003855-11-DE
• Lead Sponsor: Klinikum Großhadern, University of Munich / Medical Director: Prof. Dr. med. Burkhard Götze

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-21
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Histologically confirmed diagnosis of a locally advanced inoperable or intraabdominal (including hepatic) metastatic pancreatic adenocarcinoma with progression under preceding first-line-chemotherapy with Gemcitabine or Gemcitabine combination, or with progress during or after adjuvant chemotherapy with Gemcitabine or Gemcitabine combination
Age 18-75
Karnofsky Performance status >= 70
signed informed consent
life expectance of at least 12 weeks
sufficient organic function
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Preceding firstline chemotherapy with chemotherapeutic agents other than gemcitabine alone or in combination
second malignancy
allergy to any of the drugs used
active infection
pregnancy
polyneuropathy
hyperthermia treatment technically not conductable

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: progression free survival<br>;Secondary Objective: median survival<br>response rate<br>quality of life;Primary end point(s): progression free survival<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): median survival<br>response rate<br>quality of life