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

Pancreatic Cancer Clinical Trial

Official title:

Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00436267
• Other study ID #: CDR0000530018
• Secondary ID: CCCGHS-SIRT-SERT
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 15, 2007
• Last updated: December 18, 2013
• Start date: November 2006

Study information

• Verified date: November 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• fluorouracil

Radiation:
• selective external radiation therapy

• tomotherapy

• yttrium Y 90 glass microspheres

• yttrium Y 90 resin microspheres

Locations

Country	Name	City	State
United States	Center for Cancer Care at Goshen General Hospital	Goshen	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Goshen Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response			No
Primary	Hepatic and systemic toxicity			Yes
Secondary	Time to progression			No
Secondary	Survival			No