Pancreatic Cancer Clinical Trial
Official title:
Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer
Verified date | November 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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 as fluorouracil, work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. Giving radiation
therapy in different ways and giving it together with chemotherapy may kill more tumor
cells.
PURPOSE: This phase II trial is studying the side effects and how well giving internal
radiation therapy and external radiation therapy together with fluorouracil works in
treating patients with newly diagnosed or recurrent pancreatic cancer and liver metastases
that cannot be removed by surgery.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Center for Cancer Care at Goshen General Hospital | Goshen | Indiana |
Lead Sponsor | Collaborator |
---|---|
Goshen Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor response | No | ||
Primary | Hepatic and systemic toxicity | Yes | ||
Secondary | Time to progression | No | ||
Secondary | Survival | No |
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