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Intervention for Abdominal Cancer (PERIOP-04 Trial)
Phase 1
Waitlist Available
Led By Rebecca Auer, Doctor
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a diagnosis of a primary abdominal malignancy consented to undergo major surgery with a planned length of stay of 3 or more days.
Eligible patients must have signed a consent for surgical resection of the malignancy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at day 1, 3, 7, 10 and 35 post surgery
Awards & highlights
PERIOP-04 Trial Summary
The purpose of this study is to determine if giving Cialis for 5 days prior to surgery, on the day of surgery along with the influenza vaccine and Cialis 10 days after surgery will have an affect at the cell level for decreasing the chances of the spread of disease post surgery.
Eligible Conditions
- Abdominal Cancer
PERIOP-04 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPERIOP-04 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at day 1, 3, 7, 10 and 35 post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at day 1, 3, 7, 10 and 35 post surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the change in the number of regimen limiting toxicities (RLT) in the experimental cohort
Document the change in the number and severity of CTCAE adverse events that are probably or definitely related to study treatment (tadalafil or influenza) in the experimental cohort.
Secondary outcome measures
Compare the reduction in Natural Killer cell killing as measured on PBMC collected on SD1 as compared to baseline between the control and experimental cohorts, using a standard Natural Killer cell killing assay (51Chromium release assay).
PERIOP-04 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment2 Interventions
Cialis 20 mg daily by mouth for 16 day. 5 days prior to surgery, day of surgery and 10 days post surgery.
Influenza vaccine 0.5mL day of surgery
Group II: ControlActive Control1 Intervention
No intervention in the perioperative period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tadalafil
FDA approved
Haemagglutinin-strain A(H3N2)
FDA approved
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
559 Previous Clinical Trials
2,785,524 Total Patients Enrolled
Rebecca Auer, DoctorPrincipal InvestigatorThe Ottawa Hospital
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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