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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000064415 | Registry Identifier | PDQ (Physician Data Query) | |
| CH/UMC-95079 | |||
| NCI-V95-0760 |
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy combined with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically.
OBJECTIVES:
OUTLINE: Patients are stratified according to prior therapy (yes vs no).
Patients receive dexamethasone intratumorally, then macroaggregated albumin and interstitial phosphorus P32 intratumorally. Most patients receive a second course of this brachytherapy.
Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy. Radiotherapy is administered 5 days a week for 6.4 weeks. Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2.
Patients are followed monthly for 1 year then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone | Drug | |||
| fluorouracil | Drug | |||
| brachytherapy | Radiation | |||
| phosphorus P32 | Radiation | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | ||
| Duration of remission | ||
| Survival |
| Measure | Description | Time Frame |
|---|---|---|
| Patterns of failure |
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DISEASE CHARACTERISTICS:
Histologically proven unresectable adenocarcinoma of the pancreas limited to the head, body, or tail of the pancreas
No ascites (with or without tumor cells)
No endoscopically proven tumor penetration of duodenum or stomach
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley E. Order, MD, ScD, FACR | Center for Molecular Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northside Hospital Cancer Center | Atlanta | Georgia | 30342-1611 | United States | ||
| Center for Molecular Medicine |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D005472 | Fluorouracil |
| D001918 | Brachytherapy |
| C000615311 | Phosphorus-32 |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Garden City |
| New York |
| 11530 |
| United States |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |