Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the response/remission rate, survival, and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer. 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.

Official Title
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Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: dexamethasone
* Drug: fluorouracil
* Radiation: brachytherapy
* Radiation: phosphorus P32
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven unresectable adenocarcinoma of the pancreas limited to the head, body, or tail of the pancreas Diameter no greater than 5 cm Volume no greater than 66 mL No ascites (with or without tumor cells) No endoscopically proven tumor penetration of duodenum or stomach PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (transfusion allowed) Hepatic: No hepatic disease At least 50% uptake of technetium-sulfur colloid in normal liver if cirrhosis suspected No vascular occlusion of portal system Renal: Creatinine no greater than 1.5 mg/dL BUN no greater than 25 mg/dL Other: No Crohn's disease, ulcerative colitis, or other inflammatory bowel disease Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: If prior chemotherapy, test dose of colloidal phosphorous P32 administered prior to attempted treatment Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to pancreas, liver, or upper gastrointestinal tract Surgery: No complete surgical resection No splenectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dexamethasone|nan|
|Drug: fluorouracil|nan|
|Radiation: brachytherapy|nan|
|Radiation: phosphorus P32|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Duration of remission |  |  | 
| Survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns of failure |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas