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Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas Clinical research trials and Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas. Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas clinical trial. Human subjects often get the best healthcare possible for their Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas  Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas
Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas
For Condition: adenocarcinoma of the pancreas,stage 4A pancreatic cancer,stage 2 pancreatic cancer,stage 4B pancreatic cancer,stage 3 pancreatic cancer
Status: Recruiting
Sponsor(s): University of South Florida ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as fluorouracil and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Fluorouracil may make the tumor cells more sensitive to radiation therapy. Brachytherapy uses radioactive material, such as phosphorus P32, placed directly into or near a tumor to kill tumor cells. Combining chemotherapy and external-beam radiation therapy with brachytherapy may kill more tumor cells. PURPOSE: Randomized clinical trial to compare the effectiveness of combining fluorouracil, gemcitabine, and external-beam radiation therapy with or without brachytherapy using phosphorus P32 in treating patients who have locally or regionally advanced unresectableadenocarcinoma of the pancreas (pancreatic cancer).
Details: OBJECTIVES: Primary - Compare the survival of patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas treated with fluorouracil, external beam radiotherapy, and gemcitabine with vs without brachytherapy with phosphorus P32 suspension. Secondary - Compare time to disease progression, tumor response rate, and physical performance in patients treated with these regimens. - Compare the safety and tolerability of these regimens in this patient population. - Compare duration of response and time to treatment failure in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive phosphorus P32 suspension percutaneously under CT guidance on day 0 and at months 1, 2, 6, 7, and 8. Patients receive fluorouracil IV continuously on days 1-5 of weeks 1-6. Patients concurrently undergo external beam radiotherapy 5 days a week on weeks 1-6. At the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes once weekly for 7 weeks. After a 1-week rest, patients then receive gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment repeats every 28 days. - Arm II: Patients receive fluorouracil and gemcitabine and undergo external beam radiotherapy as in arm I. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 24-30 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed pancreatic adenocarcinoma - Locally or regionally advanced disease - Unresectable disease defined by the following: - Invasion into a major vascular structure determined preoperatively by a CT scan, angiogram, or CT portogram or intraoperatively by surgeon - Severe comorbidities precluding operation, such as congestive heart failure, coronary artery disease, or chronic obstructive pulmonary disease - Bidimensionally measurable disease by CT scan - No recurrent disease - No previously resected pancreatic cancer - No tumors of the pancreas not ductal in origin (e.g., islet cell tumors, lymphoma, or sarcoma) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count: 1,500/mm^3 - Platelet count 50,000/mm^3 - Hemoglobin 10 g/dL Hepatic - Bilirubin < 2 times upper limit of normal (ULN) - AST and ALT < 5 times ULN - Alkaline phosphatase < 5 times ULN - Albumin 2.5 mg/dL Renal - Creatinine 1.5 mg/dL Cardiovascular - See Disease Characteristics Pulmonary - See Disease Characteristics Other - No other malignancy within the past 5 years except curatively resected basal cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or early stage prostate cancer - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for pancreatic adenocarcinoma Surgery - See Disease Characteristics Other - No prior chromic phosphate P32 suspension (Phosphocol®) - At least 4 weeks since prior cytotoxic therapy for pancreatic adenocarcinoma - At least 4 weeks since prior investigational anti-tumoral agents - No other concurrent investigational agents - No other concurrent anticancer agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlexanderRosemurgy, Study Chair, University of South Florida
USF Physician's Group *Recruiting*
Tampa, Florida, 33606
United States
Recruiting Alexander Rosemurgy 813-844-7393
Additional Information:
Study ID Numbers: CDR0000355400; USFPG-6034
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079365
Other Stage 4a Pancreatic Cancer Studies:
1. Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
2. Perifosine in Treating Patients With Advanced Pancreatic Cancer
3. Paclitaxel and Bryostatin-1 in Treating Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
4. BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery
5. R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Related Studies:
Other stage 4A pancreatic cancer Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas
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