SMART for Pancreatic Cancer

Not currently recruiting at 13 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for locally advanced pancreatic cancer using Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART). This method uses MRI to guide high doses of radiation to the tumor while adapting the treatment plan daily. The researchers aim to determine if this approach can improve survival rates and quality of life without adding serious side effects. Suitable participants have been diagnosed with pancreatic cancer that cannot be surgically removed and have completed at least three months of chemotherapy. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that might enhance patient outcomes.

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.

What prior data suggests that this MRI-guided radiation therapy is safe for pancreatic cancer patients?

Research has shown that Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) is generally safe for people with pancreatic cancer. Studies have found that patients usually tolerate this treatment well, with few reports of serious side effects. For example, one study noted promising survival rates without a significant increase in major stomach or intestinal problems. This suggests the treatment is relatively safe and offers hope for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for pancreatic cancer because it represents a significant advancement over traditional radiation methods. Unlike conventional treatments, which often can't adjust in real-time to changes in tumor size or position, SMART uses MRI guidance to adapt the radiation delivery on the fly, ensuring high precision and minimizing damage to surrounding healthy tissues. This approach may enhance treatment effectiveness and reduce side effects, offering new hope for patients with this challenging condition.

What evidence suggests that SMART is effective for pancreatic cancer?

Studies have shown that a treatment called SMART, which uses advanced MRI technology to guide radiation therapy, can help patients with advanced pancreatic cancer live longer. In this trial, participants will receive Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) at a dose of 50 Gy in 5 fractions. Research indicates that higher doses of radiation, as planned in this treatment, may better control the cancer without causing more severe side effects. In previous studies, patients who received this therapy had positive results, with few experiencing serious digestive issues. This suggests that SMART could be a promising option for improving outcomes in pancreatic cancer patients who cannot undergo surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael Chuong, MD

Principal Investigator

Miami Cancer Institute

Parag Parikh, MD

Principal Investigator

Henry Ford Health System

Daniel Low, PhD

Principal Investigator

University of California, Los Angeles

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.

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

Medical/psychological contraindication to magnetic resonance imaging (MRI).

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

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38135187/

Stereotactic MR-guided on-table adaptive radiation therapy ... Long-term outcomes from the phase 2 SMART trial demonstrate encouraging OS and limited severe toxicity. Additional prospective evaluation of ...

2. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)09371-4/fulltext

Stereotactic MR-guided on-table adaptive radiation therapy ... Long-term outcomes from the phase 2 SMART trial demonstrate encouraging OS and limited severe toxicity. Additional prospective evaluation of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0167814023093714

Stereotactic MR-guided on-table adaptive radiation therapy ... Radiation dose escalation may improve local control (LC) and overall survival (OS) in select pancreatic ductal adenocarcinoma (PDAC) patients.

4. asco.org asco.org/abstracts-presentations/ABSTRACT283943

Stereotactic MR-guided on-table adaptive radiation therapy ... Background: Standard dose radiation therapy has been unsuccessful in inoperable pancreatic cancer; with a negative study (LAP07) for conventional ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37210048/

A Multi-Institutional Phase 2 Trial of Ablative 5-Fraction ... We conducted a prospective study evaluating the safety of 5-fraction Stereotactic MR-guided on-table Adaptive Radiation Therapy (SMART) for locally advanced ( ...

6. henryford.com henryford.com/news/2022/11/smart-study

Promising Safety, Patient Outcomes Data for MRI-Guided ... Findings from a recent prospective study show promising safety and patient outcomes data for locally advanced and borderline resectable pancreatic cancer ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03621644

Study Details | NCT03621644 | Stereotactic MRI-guided On ... Excellent tolerance and tumor control has been demonstrated, but median survival remained approximately 14 months. This highlights the strengths and limitations ...