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2012-03
2019-03
2021-03
336
NCT01077427
Klinikum der Universitaet Muenchen, Grosshadern
Klinikum der Universitaet Muenchen, Grosshadern
INTERVENTIONAL
Hyperthermia European Adjuvant Trial
Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through an intensified adjuvant treatment with gemcitabine, cisplatin and regional deep hyperthermia as compared to standard chemotherapy.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2010-02-25 | N/A | 2017-11-14 |
2010-02-26 | N/A | 2017-11-17 |
2010-03-01 | N/A | 2017-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Gemcitabine + Capecitabine | DRUG: Gemcitabine + Capecitabine
|
| EXPERIMENTAL: Gemcitabine + Cisplatin + regional hyperthermia | DEVICE: Gemcitabine + Cisplatin + regional hyperthermia
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival (OS) | From date of randomization until the date of death from any cause assessed up to 60 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Rolf D. Issels, MD, PhD Phone Number: +49-89-4400-77776 Email: heat@med.uni-muenchen.de |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
