A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer\
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer\
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Randall K. Pearson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000065689
NCT ID:
NCT00003049
Start Date:
May 1997
Completion Date:
July 2007
Related Keywords:
- Pancreatic Cancer
- stage I pancreatic cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- adenocarcinoma of the pancreas
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
