We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003049
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 22, 2016
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

November 1, 1999
January 27, 2003
December 22, 2016
May 1997
August 2005   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003049 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer

RATIONALE: Surgery to remove the pancreas, some of the small intestine, and lymph nodes may be more effective treatment for cancer of the pancreas than surgery to remove the pancreas and some of the small intestine alone. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery, radiation therapy, and chemotherapy may be an effective treatment for cancer of the pancreas.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the pancreas and a portion of the small intestine with or without removing lymph nodes, followed by radiation therapy and chemotherapy, in treating patients with cancer of the pancreas.


  • 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.

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: fluorouracil
  • Drug: leucovorin calcium
  • Procedure: conventional surgery
  • Radiation: radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2007
August 2005   (Final data collection date for primary outcome measure)


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • WBC at least 3500/mm^3
  • Platelet count at least 100,000/mm^3


  • Not specified


  • 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


  • 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


Biologic therapy:

  • Not specified


  • No prior chemotherapy for this disease

Endocrine therapy:

  • Not specified


  • No prior radiation therapy for this disease
  • No prior radiation therapy to the abdomen


  • Celiotomy and standardized exploration for resectability required
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA015083 ( U.S. NIH Grant/Contract )
974301 ( Other Identifier: Mayo Clinic Cancer Center )
G97-1302 ( Other Identifier: NCI Protocol )
152-97 ( Other Identifier: Mayo Clinic IRB )
Not Provided
Not Provided
Randall K. Pearson, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Randall K. Pearson, MD Mayo Clinic
Mayo Clinic
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP