Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head
NCT ID: NCT00490360
Last Updated: 2007-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
2007 participants
INTERVENTIONAL
2001-10-31
2007-05-31
Brief Summary
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Detailed Description
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Staging and restaging procedures include abdominal CT, diagnostic laparoscopy, PET/CT, tumor markers (CEA, CA 19-9) and assessment of the quality of life by the QLQ-30.
* Trial with medicinal product
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Gemcitabine / Cisplatin
Eligibility Criteria
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Inclusion Criteria
* WHO-performance status 0-2
* Written informed consent
* Discussion in an intrdisciplinary conference
Exclusion Criteria
* Uncorrectable coagulopathy
* Severe cholestasis (bilirubin \>100mmol/l)
* Distant metastases in liver, lungs or other organs
* Peritoneal carcinomatosis
* Unresectable tumor (s. 4.2.)
* Contraindication for Whipple procedure
* Uncontrolled infection
* Neurotphil count \> °2
* Estimated life experience \< 6 months
* HIV Infection
* Severe medical or psychatric comorbidities which interefere with the participation in this trial or the informed consent
* Female patients in child-bearing age without adequate contraception
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Principal Investigators
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01 Studienregister MasterAdmins
Role: STUDY_DIRECTOR
UniversitaetsSpital Zuerich
Locations
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University Hospital of Zurich, Department of Surgery
Zurich, , Switzerland
Countries
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References
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Heinrich S, Schafer M, Weber A, Hany TF, Bhure U, Pestalozzi BC, Clavien PA. Neoadjuvant chemotherapy generates a significant tumor response in resectable pancreatic cancer without increasing morbidity: results of a prospective phase II trial. Ann Surg. 2008 Dec;248(6):1014-22. doi: 10.1097/SLA.0b013e318190a6da.
Other Identifiers
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21-2001
Identifier Type: -
Identifier Source: org_study_id