Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer
dexamethasone
+ fluorouracil
+ brachytherapy
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: September 1, 1995
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.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 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
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 2 locations
Northside Hospital Cancer Center
Atlanta, United StatesOpen Northside Hospital Cancer Center in Google MapsCenter for Molecular Medicine
Garden City, United States