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| CCCGHS-SIRT-SERT |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorouracil | Drug | |||
| selective external radiation therapy | Radiation | |||
| tomotherapy | Radiation | |||
| yttrium Y 90 glass microspheres | Radiation | |||
| yttrium Y 90 resin microspheres | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response | ||
| Hepatic and systemic toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | ||
| Survival |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic cancer with liver metastases
Unresectable disease AND meets any of the following criteria:
Newly diagnosed disease
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth L. Pennington, MD | Goshen Health System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Cancer Care at Goshen General Hospital | Goshen | Indiana | 46526 | United States |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D050486 | Serotonin Plasma Membrane Transport Proteins |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D027981 | Symporters |
| D016623 | Ion Pumps |
| D026901 | Membrane Transport Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D050480 | Plasma Membrane Neurotransmitter Transport Proteins |
| D050479 | Neurotransmitter Transport Proteins |
| D000070590 | Solute Carrier Proteins |
| D008565 | Membrane Proteins |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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