SMART for Pancreatic Cancer

Recruiting at 12 trial locations

Overseen By Martin Fuss, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Viewray Inc.

Must be taking: Chemotherapy

Disqualifiers: Metastatic disease, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1-2 weeks

133 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

High-dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy delivered using daily adaptive dose planning has been shown in a retrospective study to result in improved overall survival, relative to patients receiving lower radiation doses, in patients with locally advanced pancreatic cancer, without increasing the rate of serious gastrointestinal toxicity. The goal of the proposed trial is to investigative in a controlled, prospective manner the robustness of this outcome, and to track quality of life over a 5-year trial period.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is SMART generally safe for humans?

SMART for pancreatic cancer has been shown to be generally safe, with no severe side effects reported and only low-grade side effects observed in studies. ^{1 2 3 4 5}

How is the SMART treatment for pancreatic cancer different from other treatments?

SMART (Stereotactic MRI-guided On-table Adaptive Radiation Therapy) is unique because it uses real-time MRI guidance to precisely target pancreatic tumors with high-dose radiation, even when they are close to sensitive organs. This allows for safer delivery of effective doses compared to traditional radiation therapies, which can be limited by the proximity of vital organs. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for pancreatic cancer?

Research shows that SMART can deliver high doses of radiation precisely to pancreatic tumors, even when they are close to sensitive organs, which is important for treating inoperable pancreatic cancer. Studies have reported benefits from daily adaptation of the treatment, suggesting it can be effective and safe for patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Michael Chuong, MD

Principal Investigator

Miami Cancer Institute

Daniel Low, PhD

Principal Investigator

University of California, Los Angeles

Parag Parikh, MD

Principal Investigator

Henry Ford Health System

Percy Lee, MD

Principal Investigator

MD Anderson

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My pancreatic cancer is advanced but cannot be surgically removed.

I have undergone chemotherapy for 3 months or more.

Exclusion Criteria

My cancer has spread to distant parts of my body, confirmed by a recent scan.

I've had radiation in the same area as my current cancer.

Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic MRI-guided on-table adaptive radiation therapy, 50 Gy in 5 fractions

1-2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for grade 3 or higher gastrointestinal toxicity and overall survival

90 days

3 visits (in-person)

Long-term Follow-up

Participants' overall survival and quality of life are assessed at 2 years and 12 months post-treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART)

Trial Overview 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.

How Is the Trial Designed?

Group I: Ablative MRIdian SMART Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Viewray Inc.

Lead Sponsor

Trials

13

Recruited

1,100+

Published Research Related to This Trial

The SMART3CM strategy for adaptive radiation therapy in locally advanced pancreatic cancer significantly reduces the number of required optimizations (4 vs 18) compared to the standard FULLOAR method, while maintaining equivalent target coverage (mean V95%=89%).

Using SMART3CM results in lower doses to surrounding organs at risk (OARs) and better adherence to dose constraints, demonstrating its efficacy in sparing healthy tissue during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast and robust online adaptive planning in stereotactic MR-guided adaptive radiation therapy (SMART) for pancreatic cancer. Bohoudi, O., Bruynzeel, AME., Senan, S., et al.[2022]

Stereotactic MR-guided adaptive radiotherapy (SMART) for pancreatic tumors showed no patients experiencing severe acute toxicities, with the most common side effects being mild (grade 1-2) symptoms like asthenia and nausea.

The study demonstrated promising outcomes with a median overall survival of 14.1 months and high local control rates (97% at 6 months), indicating that SMART is effective and safe for treating pancreatic tumors, with a notable secondary surgical resection rate in patients initially diagnosed with locally advanced pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic MR-Guided Radiotherapy for Pancreatic Tumors: Dosimetric Benefit of Adaptation and First Clinical Results in a Prospective Registry Study. Michalet, M., Bordeau, K., Cantaloube, M., et al.[2022]

Stereotactic magnetic resonance-guided adaptive radiation therapy (SMART) delivered an ablative dose of 50 Gy in 5 fractions to 44 patients with inoperable pancreatic adenocarcinoma, resulting in a median overall survival of 15.7 months and a 1-year survival rate of 68.2%.

The treatment demonstrated limited late toxicity, with only 4.6% of patients experiencing grade 3 gastrointestinal ulcers, indicating that SMART can effectively target tumors while minimizing harm to surrounding organs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ablative Five-Fraction Stereotactic Body Radiation Therapy for Inoperable Pancreatic Cancer Using Online MR-Guided Adaptation. Hassanzadeh, C., Rudra, S., Bommireddy, A., et al.[2022]

In a study of 54 patients with locally advanced or recurrent pancreatic cancer treated with stereotactic MR-guided on-table adaptive radiotherapy (SMART), no patients experienced significant acute gastrointestinal toxicity, demonstrating the safety of this high-dose radiation technique.

SMART achieved complete local control in 21.7% of patients, with a median follow-up of 8.9 months, indicating promising efficacy in managing pancreatic tumors, even in those with prior treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatic cancer outcome-local treatment with radiation using MRI-LINAC. Almog, G., Pfeffer, RM., Zalmanov, S., et al.[2023]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Fast and robust online adaptive planning in stereotactic MR-guided adaptive radiation therapy (SMART) for pancreatic cancer. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic MR-Guided Radiotherapy for Pancreatic Tumors: Dosimetric Benefit of Adaptation and First Clinical Results in a Prospective Registry Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Dosimetric Quality of Online Adapted Pancreatic Cancer Treatment Plans on an MRI-Guided Radiation Therapy System. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Ablative Five-Fraction Stereotactic Body Radiation Therapy for Inoperable Pancreatic Cancer Using Online MR-Guided Adaptation. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pancreatic cancer outcome-local treatment with radiation using MRI-LINAC. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic MR-Guided Adaptive Radiotherapy for Pancreatic Tumors: Updated Results of the Montpellier Prospective Registry Study. [2023]