A 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
Data Collection
Adenocarcinoma+9
+ Carcinoma
+ Digestive System Diseases
Treatment Study
Summary
Study start date: May 1, 2001
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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