Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

Cancer of the Pancreatic Head Clinical Trial

Official title:

Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490360
• Other study ID #: 21-2001
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2007
• Last updated: June 21, 2007
• Start date: October 2001
• Est. completion date: May 2007

Study information

• Verified date: June 2007
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2007
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of the Pancreatic Head

Intervention

Drug:
• Gemcitabine / Cisplatin

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich, Department of Surgery	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resectability rate > 70% after restaging		2007