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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00003049
First received: November 1, 1999
Last updated: May 10, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Cancer
 Drug: fluorouracil
Drug: leucovorin calcium
Procedure: conventional surgery
Radiation: radiation therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer\

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Estimated Enrollment: 100
Study Start Date: May 1997
Study Completion Date: July 2007
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003049

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Randall K. Pearson, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00003049     History of Changes
Other Study ID Numbers: CDR0000065689, P30CA015083, 974301, G97-1302, 152-97
Study First Received: November 1, 1999
Last Updated: May 10, 2011
Health Authority: United States: Federal Government

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
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013