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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 combination

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 combination

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003855-11-DE
Enrollment
75
Registered
2006-06-21
Start date
Unknown
Completion date
Unknown
Last updated
2012-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Combination of standard chemotherapy with Gemcitabine and Cisplatin and regional hyperthermia in patients with locally advanced or metastatic pancreatic cancer. MedDRA version: 14.1 Level: LLT Classification code 10033604 Term: Pancreatic cancer System Organ Class: 100000004864

Interventions

Product Name: Gemcitabine Pharmaceutical Form: INN or Proposed INN: Gemcitabinhydrochlorid Concentration unit: % percent Concentration type: equal Concentration number: 87,7- Product Name: Cisplatin

Sponsors

Klinikum Großhadern, University of Munich / Medical Director: Prof. Dr. med. Burkhard Götze
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: progression free survival ;Secondary Objective: median survival response rate quality of life;Primary end point(s): progression free survival—

Secondary

MeasureTime frame
Secondary end point(s): median survival response rate quality of life—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 24, 2026