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Phase III Randomized Study of Vapreotide in Patients Undergoing Elective Pancreatic Resection Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Phase III Randomized Study of Vapreotide in Patients Undergoing Elective Pancreatic Resection conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase III Randomized Study of Vapreotide in Patients Undergoing Elective Pancreatic Resection Clinical research trials and Phase III Randomized Study of Vapreotide in Patients Undergoing Elective Pancreatic Resection health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Phase III Randomized Study of Vapreotide in Patients Undergoing Elective Pancreatic Resection. Phase III Randomized Study of Vapreotide in Patients Undergoing Elective Pancreatic Resection Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Phase III Randomized Study of Vapreotide in Patients Undergoing Elective Pancreatic Resection clinical trial. Human subjects frequently get the finest healthcare available for their Phase III Randomized Study of Vapreotide in Patients Undergoing Elective Pancreatic Resection condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Randomized Study of Vapreotide in Patients Undergoing Elective Pancreatic Resection  Phase III Randomized Study of Vapreotide in Patients Undergoing Elective Pancreatic Resection
Phase III Randomized Study of Vapreotide in Patients Undergoing Elective Pancreatic Resection
For Condition: perioperative/postoperative complications,stage 1 pancreatic cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Mayo Clinic Cancer Center
Synopsis: Patient Abstract available in the near future.
Details: OBJECTIVES: I. Compare the efficacy of vapreotide versus placebo in reducing postoperative pancreatic complications in patients undergoing elective pancreatic resection. II. Compare the postoperative complications occurring within 45 days after surgery unrelated to the pancreas, days of hospitalization and survival at 45 days after surgery, number of rehospitalizations, and number of postoperative blood units or packed red blood cells administered in patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients undergo surgical resection on day 1 and receive vapreotide subcutaneously twice daily on days 1-7. Arm II: Patients undergo surgical resection and receive a placebo as in arm I. Patients are followed at days 28 and 45. PROJECTED ACCRUAL: A total of 580 patients (290 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Planned elective pancreatic resection due to presumed pancreatic tumor (either proximal or distal pancreatic lesion) or presumed neoplasm of the ampullary or periampullary region - Require peri-anastomotic drain(s) near the pancreaticoenterostomy or near the pancreatic stump closure - The following are excluded: Emergency surgery of the pancreas (acute pancreatitis, pancreatic trauma); Known chronic pancreatitis (pancreatic cancer with duct obstructive chronic pancreatitis allowed); Need for total pancreatectomy; Need for pancreatic transplantation; Need for elective pancreatic-cyst anastomosis; Need for pancreatic duct drainage operation without resection (pancreatic stents allowed if performed with partial pancreatic resection); Enucleation of a pancreatic neoplasm --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No neoadjuvant or postoperative adjuvant chemotherapy from 2 weeks before to 2 weeks after surgery - Endocrine therapy: At least 4 weeks since prior somatostatin or somatostatin analogue; No other concurrent somatostatin or somatostatin analogues - Radiotherapy: No neoadjuvant or postoperative adjuvant radiotherapy from 2 weeks before to 2 weeks after surgery - Surgery: See Disease Characteristics - Other: No concurrent pancreatic enzyme inhibitors (e.g., antiproteases); No concurrent immunosuppressive agents --Patient Characteristics-- - Age: 18 and over - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 2.0 mg/dL - Renal: Creatinine no greater than 2 times upper limit of normal - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelSarr, Study Chair, Mayo Clinic Cancer Center
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
University of Texas Medical Branch
Galveston, Texas, 77555-1329
United States
Taubman Health Care Center
Ann Arbor, Michigan, 48109
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Virginia Mason Medical Center
Seattle, Washington, 98111
United States
Moffett Cancer Center (South)
Tampa, Florida, 33601
United States
Additional Information:
Study ID Numbers: CDR0000068584; MAYO-IRB-B-234-00,NCI-G01-1938,MAYO-FDR001827
Study Start Date: March 2001
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014651
Other Perioperative/postoperative Complications Studies:
1. Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
2. Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
3. J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma
4. Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer
5. Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
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Phase III Randomized Study of Vapreotide in Patients Undergoing Elective Pancreatic Resection
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