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
NCT ID: NCT00436267
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2006-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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fluorouracil
selective external radiation therapy
tomotherapy
yttrium Y 90 glass microspheres
yttrium Y 90 resin microspheres
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Goshen Health System
OTHER
Responsible Party
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Center for Cancer Care at Goshen General Hospital
Principal Investigators
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Kenneth L. Pennington, MD
Role: STUDY_CHAIR
Goshen Health System
Locations
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Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States
Countries
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Other Identifiers
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CCCGHS-SIRT-SERT
Identifier Type: -
Identifier Source: secondary_id
CDR0000530018
Identifier Type: -
Identifier Source: org_study_id