Clinical trial NCT00436267: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Cancer
Pancreatic Cancer
Keywords: recurrent pancreatic cancer
stage IV pancreatic cancer
liver metastases
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-02-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tumor response
measure: Hepatic and systemic toxicity
Secondary outcomes:
measure: Time to progression
measure: Survival
Other outcomes:
Locations:
city: Goshen
country: United States
facility: Center for Cancer Care at Goshen General Hospital
state: Indiana
Study officials:
affiliation: Goshen Health System
name: Kenneth L. Pennington, MD
role: STUDY_CHAIR
References: