A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer
fluorouracil
+ leucovorin calcium
+ conventional surgery
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: May 1, 1997
Actual date on which the first participant was enrolled.OBJECTIVES: Assess the overall survival of patients with resectable ductal pancreatic adenocarcinoma undergoing extended versus standard pancreatoduodenectomy. OUTLINE: Patients are randomized to undergo standard pancreatoduodenectomy (PD) or PD with extended lymph node resection after an exploratory laparotomy. Patients receive adjuvant chemoradiation therapy 4-6 weeks after surgery, if no metastases are evident. Radiation therapy is given every week for 5 weeks. Fluorouracil/leucovorin calcium is administered by rapid IV push daily within 2 hours of radiation on days 1-4 of week 1 and days 29-31 of week 5. Patients are followed every 4 months for the first year, then every 6 months for the next 2 years. PROJECTED ACCRUAL: 50 patients will be accrued per group for a total of 100 patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 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.From 18 to 120 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 proven adenocarcinoma of the exocrine pancreas excluding periampullary cancer Resectable malignancy must be located in a region that can be encompassed by a radiation port of 20 x 20 cm No evidence of extranodal metastatic disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Not specified Renal: Bilateral renal function as demonstrated by excretory urogram (IVP) or abdominal CT scan with contrast OR Greater than 2/3 of one functioning kidney must be shielded during radiation therapy Other: Must have adequate oral nutrition (greater than 1200 calories daily) Greater than 5 years since prior malignancy except: Squamous cell skin cancer Basal cell skin cancer In situ cervical cancer Not pregnant or lactating Patients of reproductive potential must use effective birth control No cystic neoplasms of the pancreas No islet cell, periampullary or cholangiocarcinoma No Federal Medical Center inmates PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for this disease Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy for this disease No prior radiation therapy to the abdomen Surgery: Celiotomy and standardized exploration for resectability required
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