Neoadjuvant Chemotherapy for Resectable Cancer of the Pan... | NCT00490360

Studies
Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

NCT00490360

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Jun 22, 2007Estimated

Enrollment

2,007Actual

Phase

Phase 2

Conditions

Cancer of the Pancreatic Head

Interventions

Gemcitabine / Cisplatin

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Jun 21, 2007

First Submission Date that Met QC Criteria

Jun 21, 2007

First Posted Date

Jun 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2007

Last Update Posted Date

Jun 22, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,007Actual

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine / Cisplatin	Drug

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Zurich, Department of Surgery		Zurich			Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19092346	Derived	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.

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides