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Trial record 44 of 46 for:    SIR-Spheres

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00436267
Recruitment Status : Unknown
Verified November 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 19, 2007
Last Update Posted : December 19, 2013
Information provided by:
National Cancer Institute (NCI)

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 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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Pancreatic Cancer Drug: fluorouracil Radiation: selective external radiation therapy Radiation: tomotherapy Radiation: yttrium Y 90 glass microspheres Radiation: yttrium Y 90 resin microspheres Phase 2

Detailed Description:



  • 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.


  • 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer
Study Start Date : November 2006
Estimated Primary Completion Date : October 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Tumor response
  2. Hepatic and systemic toxicity

Secondary Outcome Measures :
  1. Time to progression
  2. Survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  • Prior surgery, chemotherapy, and biologic therapy allowed
  • No prior external beam radiotherapy to liver or pancreatic bed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00436267

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United States, Indiana
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States, 46526
Sponsors and Collaborators
Goshen Health System
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Study Chair: Kenneth L. Pennington, MD Goshen Health System

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Responsible Party: Kenneth Lee Pennington, Center for Cancer Care at Goshen General Hospital Identifier: NCT00436267     History of Changes
Other Study ID Numbers: CDR0000530018
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: November 2009
Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
stage IV pancreatic cancer
liver metastases
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs