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
|ClinicalTrials.gov Identifier: NCT00436267|
Recruitment Status : Unknown
Verified November 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 19, 2007
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Pancreatic Cancer||Drug: fluorouracil Radiation: selective external radiation therapy Radiation: tomotherapy Radiation: yttrium Y 90 glass microspheres Radiation: yttrium Y 90 resin microspheres||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer|
|Study Start Date :||November 2006|
|Estimated Primary Completion Date :||October 2009|
- Tumor response
- Hepatic and systemic toxicity
- Time to progression
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|