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A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer\


Phase 3
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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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 CenterRochester, Minnesota  55905