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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00104832 |
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 |
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Pancreatic Cancer |
Procedure: conventional surgery |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Immunologic Studies of Tumors of the Pancreas |
Estimated Enrollment: | 180 |
Study Start Date: | January 2005 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Resectable disease as evidenced by all of the following by preoperative imaging:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Study Chair: | Itzhak Avital, MD | NCI - Surgery Branch |
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 |
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 |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Gastrointestinal Neoplasms |
Endocrinopathy Adenocarcinoma Pancrelipase Recurrence Endocrine Gland Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Endocrine Gland Neoplasms |