Pancreatic CancerPhase 3NCT00014651
Vapreotide in Treating Patients Undergoing Elective Pancreatic Resection
A Phase 3 study testing vapreotide and conventional surgery in people with Pancreatic Cancer and Perioperative/Postoperative Complications, run by Mayo Clinic at 18 sites in United States.
Trial summary
RATIONALE: Drugs such as vapreotide may prevent complications following pancreatic resection. It is not yet known if vapreotide is more effective than no further therapy in preventing side effects of pancreatic resection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Cancer, Perioperative/Postoperative Complications
- What is being tested?
- vapreotide and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 18 sitesUnited States
- Study dates
- Mar 2001to Apr 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
PATIENT CHARACTERISTICS: Age: 18 to 90 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
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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Taubman Health Care Center
Ann Arbor, Michigan, 48109
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
University of Texas Medical Branch
Galveston, Texas, 77555-1329
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Loyola University Medical Center
Maywood, Illinois, 60153
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Virginia Mason Medical Center
Seattle, Washington, 98111
Moffett Cancer Center (South)
Tampa, Florida, 33601
About this study
Official title: Vapreotide in Pancreas Surgery: A Double-Blind, Placebo-Controlled, Randomized Study of Vapreotide to Prevent Post-Surgical Complications in Patients Undergoing Elective Pancreatic Resection Grant Application Title: Vapreotide to Prevent Complications of Pancreatic Resection
RATIONALE: Drugs such as vapreotide may prevent complications following pancreatic resection. It is not yet known if vapreotide is more effective than no further therapy in preventing side effects of pancreatic resection.
PURPOSE: This randomized phase III trial is studying vapreotide to see how well it works compared to a placebo in preventing complications in patients undergoing surgery for pancreatic cancer.
Read the detailed description
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.
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.
- Being tested
- vapreotide, conventional surgery
- Keywords
- perioperative/postoperative complications, stage I pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vapreotideDrug
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2004 (estimated)
- Study startMar 2001
- Primary completionMar 2001
- Study completionApr 2002
Why it stopped: Teminated by the DSMB because there are no differences between the control group and the Vapreotide group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Michael G. Sarr, MD, FACS, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014651
- Sponsor's protocol ID
- CDR0000068584
- Other IDs
- P30CA015083, MAYO-IRB-B-234-00, MAYO-FDR001827, NCI-G01-1938
- Status last verified
- Aug 2010
- First submitted
- 10 Apr 2001
- Last updated
- 10 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vapreotide in Pancreas Surgery: A Double-Blind, Placebo-Controlled, Randomized Study of Vapreotide to Prevent Post-Surgical Complications in Patients Undergoing Elective Pancreatic Resection Grant Application Title: Vapreotide to Prevent Complications of Pancreatic Resection
- ClinicalTrials.gov ID
- NCT00014651
- Acronym / sponsor ID
- CDR0000068584
- Keywords
- perioperative/postoperative complications, stage I pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Teminated by the DSMB because there are no differences between the control group and the Vapreotide group
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2001
- Primary completion
- Mar 2001 (actual)
- Study completion
- Apr 2002 (actual)
- First posted
- 5 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs such as vapreotide may prevent complications following pancreatic resection. It is not yet known if vapreotide is more effective than no further therapy in preventing side effects of pancreatic resection.
PURPOSE: This randomized phase III trial is studying vapreotide to see how well it works compared to a placebo in preventing complications in patients undergoing surgery for pancreatic cancer.
Detailed description
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.
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.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vapreotide | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Teminated by the DSMB because there are no differences between the control group and the Vapreotide group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G. Sarr, MD, FACS study chair
Mayo Clinic
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vapreotide and conventional surgery in people with Pancreatic Cancer and Perioperative/Postoperative Complications, run by Mayo Clinic at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Teminated by the DSMB because there are no differences between the control group and the Vapreotide group). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.