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Proton Beam Therapy

SMART for Pancreatic Cancer

N/A

Waitlist Available

Led By Michael Chuong, MD

Research Sponsored by Viewray Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Normal bone marrow and organ function as defined below: Absolute neutrophil count ≥ 500/mcL (microliters), Platelets ≥ 50,000/mcL, Hemoglobin ≥ 8.0 g/dL (deciliters), Total bilirubin ≤ 1.5 x IULN, Aspartate Aminotransferase AST(SGOT) / Alanine Aminotransferase ALT(SGPT) ≤ 3.0 x Institutional Upper Limit of Normal (IULN)

At least 18 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will investigate whether high-dose, magnetic resonance imaging-guided radiation therapy is more effective than lower doses of radiation in patients with locally advanced pancreatic cancer, without increasing the rate of serious gastrointestinal toxicity.

Who is the study for?

This trial is for adults with advanced pancreatic cancer that can't be surgically removed. They must have had at least 3 months of chemotherapy, be in good physical condition, and have normal organ/blood function. Pregnant or breastfeeding individuals, those with distant metastatic disease, high CA19.9 levels, recent major surgery, uncontrolled illnesses or a history of certain treatments are excluded.Check my eligibility

What is being tested?

The trial tests Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) on patients with locally advanced pancreatic cancer to see if it improves survival without increasing serious gastrointestinal side effects. It's a controlled study tracking quality of life over five years.See study design

What are the potential side effects?

While the description doesn't specify side effects for SMART therapy, similar radiation therapies may cause fatigue, skin reactions at the treatment site, nausea and potential increase in gastrointestinal toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood counts and liver function tests are within normal ranges.

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I am 18 years old or older.

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My pancreatic cancer is advanced but cannot be surgically removed.

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I have undergone chemotherapy for 3 months or more.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gastrointestinal toxicity assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5

Secondary outcome measures

Distant progression-free survival

Overall survival

Patient-reported quality of life (QOL)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ablative MRIdian SMARTExperimental Treatment1 Intervention

Radiation: Stereotactic MRI-guided On-table Adaptive Radiation Therapy 50 Gy in 5 fractions

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Viewray Inc.Lead Sponsor

12 Previous Clinical Trials

956 Total Patients Enrolled

Michael Chuong, MDPrincipal InvestigatorMiami Cancer Institute

1 Previous Clinical Trials

30 Total Patients Enrolled

Parag J Parikh, MDPrincipal InvestigatorHenry Ford Health System

Media Library

Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03621644 — N/A

Pancreatic Cancer Research Study Groups: Ablative MRIdian SMART

Pancreatic Cancer Clinical Trial 2023: Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) Highlights & Side Effects. Trial Name: NCT03621644 — N/A

Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03621644 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a possibility for participation in this experiment currently available?

"Unfortunately, this clinical trial is not presently accepting candidates. This medical study was initially posted on January 1st 2019 and its most recent update occurred on October 11th 2022. However, 703 other trials are actively recruiting patients at the moment."

Answered by AI

Are there multiple sites where this research endeavor is taking place?

"Henry Ford Health Sciences, Providence Portland Cancer Center, and Orlando Health are three of the medical sites conducting this study. Additionally, there are twelve other participating institutions located across the country."

Answered by AI

Recent research and studies

Cancer MedicineJournal

Using Adaptive Magnetic Resonance Image‐guided Radiation Therapy for Treatment of Inoperable Pancreatic Cancer

Rudra, Soumon, Naomi Jiang, Stephen A. Rosenberg, Jeffrey R. Olsen, Michael C. Roach, Leping Wan, Lorraine Portelance, et al.. 2019. “Using Adaptive Magnetic Resonance Image‐guided Radiation Therapy for Treatment of Inoperable Pancreatic Cancer”. Cancer Medicine. Wiley. doi:10.1002/cam4.2100.

clinicaltrials.govStudy

Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer

2019. "Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03621644.

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