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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

No Placebo-Only Group

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months post-treatment for reporting.

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 more

Other study objectives

Patient reported quality of life assessment- review of symptoms and how they interfere in life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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