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Losartan + Radiation Therapy for Pancreatic Cancer (SHAPER Trial)
Phase 1
Recruiting
Led By Shane Lloyd
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed pancreatic ductal adenocarcinoma
Borderline resectable or locally advanced unresectable pancreas cancer as defined by the National Comprehensive Cancer Network (NCCN) and determined by a pancreatic surgeon prior to therapy
Must not have
Patients with known evidence of chronic hepatitis B virus (HBV) infection and a detectable HBV viral load
Patients taking direct renin-angiotensin system inhibitors including aliskiren (Rasilez)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months post-treatment
Awards & highlights
Summary
This trial is studying losartan and hypofractionated radiation therapy to see if they are effective in treating pancreatic cancer.
Who is the study for?
This trial is for patients with pancreatic cancer that's borderline resectable or locally advanced and unresectable. They must have had at least one round of specific chemotherapy, be within certain blood and organ function parameters, not pregnant, willing to use effective contraception, and able to consent. Exclusions include those on high-dose losartan, other trials, prior malignancies affecting safety assessments, previous radiation or surgery for pancreatic cancer, uncontrolled ulcers or chronic coughs among others.
What is being tested?
The SHAPER trial is testing the combination of losartan (a drug that may improve blood flow) with hypofractionated radiation therapy (which delivers higher doses in a shorter period), following chemotherapy. The goal is to see if this combo is more effective than just radiation alone in treating pancreatic cancer by killing more tumor cells with fewer side effects.
What are the potential side effects?
Potential side effects from losartan might include low blood pressure symptoms like dizziness or fainting. Radiation therapy can cause skin irritation at the treatment site, fatigue, nausea and potential damage to nearby organs depending on its location.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed as pancreatic ductal adenocarcinoma.
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My pancreas cancer is advanced but hasn't been removed.
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I have tried FOLFIRINOX or gemcitabine chemotherapy.
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I am fully active and can carry on all pre-disease activities without restriction.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have chronic hepatitis B with a detectable virus level.
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I am currently taking medication for my blood pressure that includes aliskiren.
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I have had radiation or surgery for pancreatic cancer.
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I have a single kidney, narrowed kidney arteries, or ongoing kidney failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Grade 3 or higher gastrointestinal toxicity rate
Secondary study objectives
Frequency of adverse events
Number patients that require a medical intervention or hospitalization due to hypotension
Overall survival (OS)
+2 moreOther study objectives
Patient reported quality of life assessment- review of symptoms and how they interfere in life
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (losartan, hypofractionated radiation therapy)Experimental Treatment5 Interventions
Beginning on day 1, patients receive losartan potassium PO QD. Beginning day 14, patients also undergo hypofractionated radiation therapy over 15 fractions 5 days a week for up to 3 weeks. Patients continue to receive losartan potassium PO QD during radiation therapy and for 28 days after completion of radiation therapy. Patients may begin additional anti-cancer therapy per investigator discretion after the last dose of HRT. Losartan can be given concurrently with additional therapy and Losartan dosing can continue until 28 days after last dose of HRT, regardless of when additional therapy is started.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 3
~130
Losartan
2003
Completed Phase 4
~3000
Losartan Potassium
2007
Completed Phase 4
~1060
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,127 Previous Clinical Trials
1,793,174 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,977 Total Patients Enrolled
Shane LloydPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to distant parts of my body, but may also be in nearby lymph nodes.My cancer is confirmed as pancreatic ductal adenocarcinoma.I have tried FOLFIRINOX or gemcitabine chemotherapy.I don't have another cancer that could affect this trial's safety or results.I take more than 50mg of losartan daily and cannot reduce it.I am enrolling within 3 months after my last chemotherapy session.Your platelet count is at least 100,000 per microliter.I have chronic hepatitis B with a detectable virus level.Your blood potassium level is less than 5.0 mmol/L.I am currently taking medication for my blood pressure that includes aliskiren.My pancreas cancer is advanced but hasn't been removed.I am fully active and can carry on all pre-disease activities without restriction.I am on blood pressure medication that cannot be safely stopped before starting the trial.I haven't had uncontrolled stomach ulcers in the last 28 days.I have hepatitis C but haven't been treated, or I'm being treated and my viral load is undetectable.I am HIV positive and not on effective treatment or have had a detectable viral load in the last 6 months.Your blood creatinine level is less than 1.25 md/dL.I have had a chronic cough for many days over the past 3 to 12 months.I am using or willing to use effective birth control during and for 12 months after the study.Women who can have babies need to have a negative pregnancy test before joining the study.My heart failure is mild to moderate, classified as 2B or better.I have been checked for heart issues due to past treatments before joining.The levels of certain liver enzymes in your blood should not be more than 2.5 times the normal limit.Your body has enough infection-fighting white blood cells.Your total bilirubin level should be less than or equal to 2.0 mg/dL.I have had radiation or surgery for pancreatic cancer.I have recovered from previous treatment side effects, or they are minor and stable.I have low blood pressure that could make treatment unsafe for me.I have a single kidney, narrowed kidney arteries, or ongoing kidney failure.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (losartan, hypofractionated radiation therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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