Neoadjuvant Chemotherapy For Resectable Cancer Of The Pancreatic Head

Study Overview

Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.

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

Cancer of the Pancreatic Head

DRUG: Gemcitabine / Cisplatin

21-2001

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-06-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2007-06-21
First Submitted that Met QC Criteria 2007-06-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2007-06-22
First Posted (ESTIMATED) 2007-06-22	Results First Posted N/A	Last Verified 2007-06

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Resectability rate > 70% after restaging		2007

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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 > Â°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

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: 01 Studienregister MasterAdmins, UniversitaetsSpital Zuerich

Publications

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

General Publications

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.

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Resources

PatientS

Caregivers

Clinical Trial Record