Status:
UNKNOWN
Internal Radiation Therapy With Y-90 Microspheres, External Radiation Therapy With Tomotherapy, and Fluorouracil in Treating Patients With Newly Diagnosed or Recurrent Pancreatic Cancer and Liver Metastases That Cannot Be Removed By Surgery
Lead Sponsor:
Goshen Health System
Conditions:
Metastatic Cancer
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such...
Detailed Description
OBJECTIVES: Primary * Determine tumor response in patients with unresectable, newly diagnosed or recurrent pancreatic cancer and liver metastases treated with selective internal radiotherapy with yt...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed pancreatic cancer with liver metastases
- Unresectable disease AND meets any of the following criteria:
- Newly diagnosed disease
- No prior treatment
- Received prior treatment and progressed
- Underwent prior pancreatectomy and progressed
- Liver-only disease (receives selective internal radiotherapy only)
- No known CNS metastases
- No known diffuse peritoneal metastases
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 80-100%
- Life expectancy \> 3 months
- WBC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Bilirubin \< 2 mg/dL (without extrahepatic biliary obstruction)
- Albumin \> 2 g/dL
- Creatinine \< 2 mg/dL
- Not pregnant
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior surgery, chemotherapy, and biologic therapy allowed
- No prior external beam radiotherapy to liver or pancreatic bed
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00436267
Start Date
November 1 2006
Last Update
December 19 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States, 46526