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Surgery in Treating Patients With Resectable Pancreatic Neoplasms
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
First Received: March 3, 2005   Last Updated: February 6, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00104832
  Purpose

RATIONALE: Surgery may be an effective way to treat pancreatic neoplasms.

PURPOSE: This clinical trial is studying how well surgery works in treating patients with resectable pancreatic neoplasms.


Condition Intervention
Pancreatic Cancer
Procedure: conventional surgery

MedlinePlus related topics: Cancer Pancreatic Cancer Surgery
Drug Information available for: Pancrelipase Ultrase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Immunologic Studies of Tumors of the Pancreas

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 180
Study Start Date: January 2005
Detailed Description:

OBJECTIVES:

Primary

  • Obtain tumor tissue and lymphocytes, to identify tumor-specific antigens and their HLA-restricted epitopes, from patients with resectable pancreatic neoplasms or suspected mass undergoing standard surgical resection.

Secondary

  • Determine survival of patients treated with this regimen.

OUTLINE: All patients are assessed to verify tumor resectability. Patients with disease outside the pancreatic resection bed (portal vein or superior mesenteric vein involvement) are removed from the study. All other patients undergo standard resection of the primary tumor. Patients are then referred for appropriate adjuvant therapy or treatment under a separate NIH protocol based on tumor histology.

After completion of study therapy, patients are followed at 1 month, every 3-4 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 180 patients (20 per histological type) will be accrued for this study within 4-7 years.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of a pancreatic or ampullary mass or malignant stricture of the pancreas by radiography or endoscopy
  • Resectable disease as evidenced by all of the following by preoperative imaging:

    • No metastasis outside the pancreas and peripancreatic nodes
    • Superior mesenteric venous-portal system patent
    • No superior mesenteric artery involvement
  • No evidence of distant metastases

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 2,500/mm^3
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 50,000/mm^3

Hepatic

  • Hepatitis B surface antigen negative
  • Hepatitis C virus antibody negative
  • No history of cirrhosis

Renal

  • Creatinine ≤ 2.5 mg/dL

Cardiovascular

  • No severe congestive heart failure
  • No active ischemic heart disease

Immunologic

  • HIV negative
  • No other primary or secondary immunodeficiency as evidenced by presence of opportunistic infections
  • No active infection

Other

  • Not pregnant
  • Negative pregnancy test
  • No other malignancy requiring systemic therapy
  • No history of any other significant medical problem that would preclude surgery

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior immunotherapy for pancreatic neoplasm allowed

Chemotherapy

  • Prior chemotherapy for pancreatic neoplasm allowed

Endocrine therapy

  • Prior hormonal therapy for pancreatic neoplasm allowed

Radiotherapy

  • Prior radiotherapy for pancreatic neoplasm allowed

Surgery

  • Not specified

Other

  • Recovered from all prior therapy for pancreatic neoplasm
  • More than 3 weeks since prior and no concurrent systemic therapy for pancreatic neoplasm
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104832

Locations
United States, Maryland
NCI - Surgery Branch Recruiting
Bethesda, Maryland, United States, 20892
Contact: Itzhak Avital, MD     866-820-4505        
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Investigators
Study Chair: Itzhak Avital, MD NCI - Surgery Branch
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000415533, NCI-05-C-0044
Study First Received: March 3, 2005
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00104832     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
stage I pancreatic cancer
stage II pancreatic cancer
acinar cell adenocarcinoma of the pancreas
adenocarcinoma of the pancreas
duct cell adenocarcinoma of the pancreas

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Adenocarcinoma
Pancrelipase
Recurrence
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009