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Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490360
First Posted: June 22, 2007
Last Update Posted: June 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Zurich
  Purpose
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.

Condition Intervention Phase
Cancer of the Pancreatic Head Drug: Gemcitabine / Cisplatin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Resectability rate > 70% after restaging [ Time Frame: 2007 ]

Enrollment: 2007
Study Start Date: October 2001
Study Completion Date: May 2007
Detailed Description:

Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Two cycles of chemotherapy are given on day 1 and 15 each. After restaging excludes disease progression, a standard Whipple procedure is performed.

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria: - Age > 18 years

  • Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head
  • WHO-performance status 0-2
  • Written informed consent
  • Discussion in an intrdisciplinary conference

Exclusion criteria: - Insufficient renal function (calculated creatinin clearance < 60ml(min)

  • Insufficient hematologic function (neutrophil count <1'000/ul, platelets < 100'000/ul)
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490360


Locations
Switzerland
University Hospital of Zurich, Department of Surgery
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00490360     History of Changes
Other Study ID Numbers: 21-2001
First Submitted: June 21, 2007
First Posted: June 22, 2007
Last Update Posted: June 22, 2007
Last Verified: June 2007

Additional relevant MeSH terms:
Gemcitabine
Cisplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs