Suspended

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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What is being tested

fluorouracil

+ gemcitabine hydrochloride
+ brachytherapy
Drug
Radiation
Who is being recruted

Pancreatic Cancer

Over 18 Years
How is the trial designed

Treatment Study

Interventional
Study Start: May 2001

Summary

Principal SponsorUniversity of South Florida
Last updated: December 4, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2001Actual date on which the first participant was enrolled.

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: This randomized clinical trial is studying fluorouracil, gemcitabine, external-beam radiation therapy, and brachytherapy using phosphorus P32 to see how well they work compared to fluorouracil, gemcitabine, and external-beam radiation therapy in treating patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas (pancreatic cancer). 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.

Official TitleA Randomized Trial Comparing 5-Fluorouracil, External Beam Radiation, and Gemcitabine With or Without P Radiopharmaceutical Therapy As A First Line Therapy in Patients With Locally/Regionally Advanced Non-Resectable Adenocarcinoma of the Pancreas 
Principal SponsorUniversity of South Florida
Last updated: December 4, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pancreatic Cancer
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
USF Physician's GroupTampa, United StatesSee the location

SuspendedOne Study Center