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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 recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00436267
First received: February 15, 2007
Last updated: December 18, 2013
Last verified: November 2009

February 15, 2007
December 18, 2013
November 2006
October 2009   (final data collection date for primary outcome measure)
  • Tumor response [ Designated as safety issue: No ]
  • Hepatic and systemic toxicity [ Designated as safety issue: Yes ]
  • Tumor response
  • Hepatic and systemic toxicity
Complete list of historical versions of study NCT00436267 on ClinicalTrials.gov Archive Site
  • Time to progression [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Time to progression
  • Survival
Not Provided
Not Provided
 
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
Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
Not Provided
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00436267
CDR0000530018, CCCGHS-SIRT-SERT
Not Provided
Kenneth Lee Pennington, Center for Cancer Care at Goshen General Hospital
Goshen Health System
Not Provided
Study Chair: Kenneth L. Pennington, MD Goshen Health System
National Cancer Institute (NCI)
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP