Status:
COMPLETED
Stereotactic Radiation Therapy and Combination Chemotherapy in Treating Patients Undergoing Surgery for Locally Advanced Pancreatic Cancer
Lead Sponsor:
Technical University of Munich
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work...
Detailed Description
OBJECTIVES: Primary * Determine the clinical response rate in patients undergoing surgery for locally advanced pancreatic cancer treated with stereotactic radiotherapy, gemcitabine hydrochloride, an...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas or intrapancreatic bile duct carcinoma
- Overall view of image morphology and CA19-9 (\< 500 U/L) demonstrating pancreatic cancer allowed if histologic/cytologic confirmation is unavailable
- Locally advanced disease, meeting 1 of the following criteria:
- Uncertain R0 resectability dependant on relation to portal vein, sinus confluens, superior mesenteric artery, and superior mesenteric vein (e.g., contact with portal vein, superior mesenteric vein, or arterial vessels, but \< 180° encasement)
- Unresectable pancreatic cancer (e.g., contact with portal vein, superior mesenteric artery or arterial vessels, \> 180° encasement)
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 1 cm by spiral CT scan or MRI
- Patients with no measurable disease may be assessed for feasibility only
- No distant metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
- WBC ≥ 3,000/mm³
- Granulocyte count ≥ 2,000/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine clearance \> 30 mL/min
- Bilirubin ≤ 3.0 times upper limit of normal
- AST and ALT ≤ 2.5 times normal
- Alkaline phosphatase ≤ 2.5 times normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No secondary malignancy within the past 5 years that was not curatively treated
- No known intolerance to any of the study drugs
- No preexisting polyneuropathy \> grade 1
- No active uncontrolled infection
- No cardiac insufficiency despite optimal medication
- No New York Heart Association class III or IV congestive heart failure
- LVEF ≥ 50% OR shortening fraction ≥ 25%
- No angina pectoris (at rest or under stress) unexplained by interventional cardiology within the past 6 months
- No myocardial infarction within the past 6 months
- No uncontrolled diabetes mellitus
- No other existing serious medical impairments that would preclude study compliance
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No prior radiotherapy to the abdomen
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00425841
Start Date
May 1 2006
End Date
December 1 2009
Last Update
December 12 2012
Active Locations (1)
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1
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675