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Losartan + Radiation Therapy for Pancreatic Cancer (SHAPER Trial)
SHAPER Trial Summary
This trial is studying losartan and hypofractionated radiation therapy to see if they are effective in treating pancreatic cancer.
SHAPER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSHAPER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SHAPER Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Treatment (losartan, hypofractionated radiation therapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are there any current opportunities to participate in the clinical trial?
"Per data provided by clinicaltrials.gov, this research project is currently enlisting test subjects. The study was initially posted on the 8th of August 2019 and most recently edited on May 3rd 2022."
What conditions may be rectified with Hypofractionated Radiation Therapy?
"Hypofractionated Radiation Therapy is commonly used to manage diabetic nephropathy and has been found useful in treating left ventricular hypertrophy, proteinuria, and hypertensive disease."
What is the maximum capacity of volunteers for this research project?
"Affirmative. As evidenced on clinicaltrials.gov, this medical trial is actively seeking participants as of May 3rd 2022 since its original posting date of August 8th 2019. There are 20 patients required for the study to be conducted at one site location."
Is Hypofractionated Radiation Therapy a dangerous treatment for patients?
"Hypofractionated Radiation Therapy is a relatively new intervention, so its safety rating was set as 1 due to the limited clinical data supporting efficacy and safety."
Has Hypofractionated Radiation Therapy been subjected to testing in other experiments?
"At the moment, there are 30 ongoing trials examining Hypofractionated Radiation Therapy with 2 of these reaching Phase 3. While San Francisco has the majority of studies involving this therapy, 533 other locations across the world feature clinical trial related to it."
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