Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

June 21, 2007 updated by: University of Zurich
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

2007

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • University Hospital of Zurich, Department of Surgery

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resectability rate > 70% after restaging
Time Frame: 2007
2007

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start

October 1, 2001

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

June 21, 2007

First Submitted That Met QC Criteria

June 21, 2007

First Posted (Estimate)

June 22, 2007

Study Record Updates

Last Update Posted (Estimate)

June 22, 2007

Last Update Submitted That Met QC Criteria

June 21, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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