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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic Identifier:
First received: November 1, 1999
Last updated: December 20, 2016
Last verified: May 2011

November 1, 1999
December 20, 2016
May 1997
August 2005   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003049 on Archive Site
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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
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*   Includes publications given by the data provider as well as publications identified by 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 ( US NIH Grant/Contract Award Number )
974301 ( Other Identifier: Mayo Clinic Cancer Center )
G97-1302 ( Other Identifier: NCI Protocol )
152-97 ( Other Identifier: Mayo Clinic IRB )
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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