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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: November 16, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response [ Designated as safety issue: No ]
  • Hepatic and systemic toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2006
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436267

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Kenneth Lee Pennington, Center for Cancer Care at Goshen General Hospital
ClinicalTrials.gov Identifier: NCT00436267     History of Changes
Other Study ID Numbers: CDR0000530018, CCCGHS-SIRT-SERT
Study First Received: February 15, 2007
Last Updated: November 16, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
stage IV pancreatic cancer
liver metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Pancreatic Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
 Endocrine System Diseases
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013