Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT00490360
• Collaborator: (none)
• Enrollment: 2,007
• Location: 1
• Duration (Months): 67
• Patients Per Site Per Month: 30

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer of the Pancreatic Head	Drug: Gemcitabine / Cisplatin	Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 2007 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head
• Study Start Date: Oct 1, 2001
• Actual Study Completion Date: May 1, 2007

Outcome Measures

Primary Outcome Measures

1. Resectability rate > 70% after restaging [2007]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Zurich, Department of Surgery	Zurich		Switzerland

Sponsors and Collaborators

• University of Zurich

Investigators

• Study Director: 01 Studienregister MasterAdmins, UniversitaetsSpital Zuerich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00490360
• Other Study ID Numbers: 21-2001
• First Posted: Jun 22, 2007
• Last Update Posted: Jun 22, 2007
• Last Verified: Jun 1, 2007

• Additional relevant MeSH terms: Gemcitabine

Study Results

No Results Posted as of Jun 22, 2007