This trial is active, not recruiting.

Conditions metastatic cancer, pancreatic cancer
Treatments fluorouracil, selective external radiation therapy, tomotherapy, yttrium y 90 glass microspheres, yttrium y 90 resin microspheres
Phase phase 2
Sponsor Goshen Health System
Start date November 2006
End date October 2009
Trial size 20 participants
Trial identifier NCT00436267, CCCGHS-SIRT-SERT, CDR0000530018


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Tumor response
time frame:
Hepatic and systemic toxicity
time frame:

Secondary Outcomes

Time to progression
time frame:
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).