Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head - Full Text View

Sponsored by:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00490360

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 II

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

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 > 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

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

Publications indexed to this study:

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.

Study ID Numbers:	21-2001
Study First Received:	June 21, 2007
Last Updated:	June 21, 2007
ClinicalTrials.gov Identifier:	NCT00490360
Health Authority:	Switzerland: Swissmedic

Study placed in the following topic categories:

Cisplatin
Gemcitabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009