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
Recruitment status was: Active, not recruiting
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.
Radiation: selective external radiation therapy
Radiation: yttrium Y 90 glass microspheres
Radiation: yttrium Y 90 resin microspheres
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer|
- Tumor response [ Designated as safety issue: No ]
- Hepatic and systemic toxicity [ Designated as safety issue: Yes ]
- Time to progression [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Estimated Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436267
|United States, Indiana|
|Center for Cancer Care at Goshen General Hospital|
|Goshen, Indiana, United States, 46526|
|Study Chair:||Kenneth L. Pennington, MD||Goshen Health System|