Metastatic Cancer, Pancreatic Cancer
Conditions
Keywords
recurrent pancreatic cancer, stage IV pancreatic cancer, liver metastases
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.
Interventions
DRUGfluorouracil
RADIATIONselective external radiation therapy
RADIATIONtomotherapy
RADIATIONyttrium Y 90 glass microspheres
RADIATIONyttrium Y 90 resin microspheres
Sponsors
Goshen Health System
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response | — |
| Hepatic and systemic toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | — |
| Survival | — |
Countries
United States
Outcome results
None listed