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Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

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ClinicalTrials.gov Identifier: NCT00490360
Recruitment Status : Completed
First Posted : June 22, 2007
Last Update Posted : June 22, 2007
Sponsor:
Information provided by:
University of Zurich

Tracking Information
First Submitted Date  ICMJE June 21, 2007
First Posted Date  ICMJE June 22, 2007
Last Update Posted Date June 22, 2007
Study Start Date  ICMJE October 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2007)
Resectability rate > 70% after restaging [ Time Frame: 2007 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head
Official Title  ICMJE Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head
Brief Summary Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer of the Pancreatic Head
Intervention  ICMJE Drug: Gemcitabine / Cisplatin
Study Arms  ICMJE Not Provided
Publications * Heinrich S, Schäfer 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2007)
2007
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00490360
Other Study ID Numbers  ICMJE 21-2001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
PRS Account University of Zurich
Verification Date June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP