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Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00490360
First received: June 21, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Zurich

Additional 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
Study First Received: June 21, 2007
Last Updated: June 21, 2007
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on June 17, 2013