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| Sponsor: | Klinikum der Universitaet Muenchen, Grosshadern |
|---|---|
| Collaborators: |
European Society for Hyperthermic Oncology Institute for Medical Informatics, Biometry and Epidemiology, Munich ClinAssess GmbH, Leverkusen, Germany |
| Information provided by: | Klinikum der Universitaet Muenchen, Grosshadern |
| ClinicalTrials.gov Identifier: | NCT01077427 |
Purpose
The addition of regional hyperthermia to standard chemotherapy (gemcitabine) in an adjuvant setting may improve the outcome of patients with pancreatic cancer. The present trial is performed in order to confirm the hypothesis that the addition of regional hyperthermia (RHT) to gemcitabine standard therapy (G + RHT) for pancreatic cancer patients after R0/R1-tumor resection is superior to gemcitabine standard therapy alone (G).
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Adenocarcinoma |
Device: Gemcitabine + regional hyperthermia Drug: Gemcitabine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III, Randomized, Open Multicenter Trial of Adjuvant Gemcitabine Chemotherapy With the Addition of Regional Hyperthermia in First-line Treatment of Patients With R0/R1 Resected Pancreatic Carcinoma |
| Estimated Enrollment: | 366 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Gemcitabine: Active Comparator
Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course
|
Drug: Gemcitabine
Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course
|
|
Gemcitabine + regional hyperthermia: Experimental
Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course Regional hyperthermia: 60 minutes / 42˚C on days 2, 9, and 16 of each course
|
Device: Gemcitabine + regional hyperthermia
Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course Regional hyperthermia: 60 minutes / 42˚C on days 2, 9, and 16 of each course
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
adequate bone marrow function defined as
adequate renal function defined as
adequate coagulatory function defined as
Exclusion Criteria:
Contacts and Locations| Contact: Rolf D. Issels, MD, PhD | +49-89-7095-4768 | Rolf.Issels@med.uni-muenchen.de |
| Germany, Bavaria | |
| Hospital of the University of Munich | |
| Munich, Bavaria, Germany, 81377 | |
| Principal Investigator: | Rolf D. Issels, MD, PhD | Hospital of the University of Munich, Campus Grosshadern, Germany |
More Information
| Responsible Party: | Klinikum der Universitaet Muenchen, Grosshadern ( Rolf D. Issels, MD, PhD ) |
| ClinicalTrials.gov Identifier: | NCT01077427 History of Changes |
| Other Study ID Numbers: | 115-09 |
| Study First Received: | February 25, 2010 |
| Last Updated: | March 15, 2010 |
| Health Authority: | Germany: Ethics Committee of Hospital of the University of Munich |
|
Pancreas Cancer Adenocarcinoma R0 or R1 resected ductal pancreatic adenocarcinoma |
|
Adenocarcinoma Fever Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Body Temperature Changes Signs and Symptoms Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |