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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

Primary Purpose

Metastatic Cancer, Pancreatic Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fluorouracil
selective external radiation therapy
tomotherapy
yttrium Y 90 glass microspheres
yttrium Y 90 resin microspheres
Sponsored by
Goshen Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring recurrent pancreatic cancer, stage IV pancreatic cancer, liver metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Cancer Care at Goshen General Hospital

Outcomes

Primary Outcome Measures

Tumor response
Hepatic and systemic toxicity

Secondary Outcome Measures

Time to progression
Survival

Full Information

First Posted
February 15, 2007
Last Updated
December 18, 2013
Sponsor
Goshen Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00436267
Brief Title
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
Official Title
Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Goshen Health System

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Pancreatic Cancer
Keywords
recurrent pancreatic cancer, stage IV pancreatic cancer, liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Radiation
Intervention Name(s)
selective external radiation therapy
Intervention Type
Radiation
Intervention Name(s)
tomotherapy
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 glass microspheres
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 resin microspheres
Primary Outcome Measure Information:
Title
Tumor response
Title
Hepatic and systemic toxicity
Secondary Outcome Measure Information:
Title
Time to progression
Title
Survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth L. Pennington, MD
Organizational Affiliation
Goshen Health System
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Cancer Care at Goshen General Hospital
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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