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
This trial is active, not recruiting.
|Conditions||metastatic cancer, pancreatic cancer|
|Treatments||fluorouracil, selective external radiation therapy, tomotherapy, yttrium y 90 glass microspheres, yttrium y 90 resin microspheres|
|Sponsor||Goshen Health System|
|Start date||November 2006|
|End date||October 2009|
|Trial size||20 participants|
|Trial identifier||NCT00436267, CCCGHS-SIRT-SERT, CDR0000530018|
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.
Hepatic and systemic toxicity
Time to progression
Male or female participants at least 18 years old.
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
|Official title||Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer|
|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 yttrium Y 90 microspheres, selective external radiotherapy with tomotherapy, and fluoroucacil. - Determine hepatic and systemic toxicity of this regimen in these patients. Secondary - Determine the efficacy of this regimen, in terms of time to progression and survival, in these patients. OUTLINE: Patients receive fluorouracil IV continuously on days 1-4. Patients undergo selective internal radiotherapy with yttrium Y 90 microspheres on day 2 and selective external radiotherapy with tomotherapy on day 3. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.|
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