NCT00490360

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,007

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2007

Completed
Last Updated

June 22, 2007

Status Verified

June 1, 2007

First QC Date

June 21, 2007

Last Update Submit

June 21, 2007

Conditions

Cancer of the Pancreatic Head

Outcome Measures

Primary Outcomes (1)

  • Resectability rate > 70% after restaging

    2007

Interventions

Gemcitabine / CisplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich, Department of Surgery

Zurich, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 19092346DERIVED

MeSH Terms

Interventions

GemcitabineCisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2007

First Posted

June 22, 2007

Study Start

October 1, 2001

Study Completion

May 1, 2007

Last Updated

June 22, 2007

Record last verified: 2007-06

Locations

CH(1)