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. 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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: fluorouracil Drug: leucovorin calcium Procedure: conventional surgery Radiation: radiation therapy Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer
Study Start Date : May 1997
Actual Primary Completion Date : August 2005
Actual Study Completion Date : July 2007

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003049

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Randall K. Pearson, MD Mayo Clinic

Responsible Party: Randall K. Pearson, M.D., Mayo Clinic Cancer Center Identifier: NCT00003049     History of Changes
Other Study ID Numbers: CDR0000065689
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 )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: May 2011

Keywords provided by Mayo Clinic:
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents