Adaptive Radiation Therapy for Pancreatic Cancer

(ARTIA-Pancreas Trial)

Recruiting at 2 trial locations

Overseen By Jennifer Woo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Varian, a Siemens Healthineers Company

Must not be taking: Investigational agents

Disqualifiers: Active cancer, Uncontrolled illness, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 week

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using radiation therapy for treating certain types of pancreatic cancer that are difficult to operate on. The focus is on a targeted radiation approach, specifically Daily Adaptive External Beam Radiation Therapy, to determine if it can reduce side effects in the stomach and intestines while also assessing its impact on patient survival and quality of life. Suitable candidates for this trial have pancreatic cancer that cannot be surgically removed and have already undergone a few months of chemotherapy. As an unphased trial, this study provides patients with the opportunity to explore innovative treatment options that may enhance their quality of life.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop your systemic therapy (like chemotherapy) at least one week before starting the trial treatment and continue the break for at least one week after the treatment ends.

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

Research has shown that stereotactic adaptive radiation therapy, a targeted form of radiation treatment, is both safe and effective. Studies have found that this therapy can deliver high doses of radiation directly to tumors while minimizing side effects, particularly in pancreatic cancer cases.

One study noted that this treatment precisely targets tumors, reducing unnecessary exposure to nearby healthy tissues. As a result, patients experience fewer side effects and generally tolerate the treatment well. This makes it a promising option for those with pancreatic cancer that cannot be surgically removed or is difficult to operate on.

Overall, the treatment is considered safe with a low risk of severe side effects, which is encouraging for anyone considering participation in a trial involving this therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Daily Adaptive External Beam Radiation Therapy for pancreatic cancer because it offers a more personalized approach to radiation treatment. Unlike traditional methods, which use a one-size-fits-all approach, this treatment adapts to changes in the patient's anatomy daily, potentially increasing precision and effectiveness. By using the Varian Ethos treatment system, this method delivers tailored radiation doses that can better target the tumor while minimizing damage to surrounding healthy tissues. This adaptive approach could lead to improved outcomes and fewer side effects compared to conventional radiation therapy.

What evidence suggests that Daily Adaptive External Beam Radiation Therapy is effective for pancreatic cancer?

Research shows that adaptive radiation therapy, which participants in this trial will receive, effectively treats pancreatic cancer. Studies have found that increasing the radiation dose may help prevent the cancer from spreading and improve survival rates in patients with pancreatic ductal adenocarcinoma. For those with locally advanced pancreatic cancer, this type of radiation therapy has led to high rates of successful cancer-removal surgery. This suggests that adaptive radiation therapy could better manage pancreatic cancer by precisely targeting the tumor and adjusting treatment as needed. ^{1 2 3 4 6}

Who Is on the Research Team?

Lauren Henke, MD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for adults with a specific type of pancreatic cancer that's borderline-resectable, locally-advanced, or inoperable. Participants must have had at least two months of chemotherapy and be able to hold their breath as instructed during treatment. Pregnant individuals, those with certain heart conditions, active infections, or other cancers within the last year can't join.

Inclusion Criteria

My cancer has spread to no more than 3 nearby lymph nodes.

My scans clearly show the area needing treatment and nearby critical organs.

I can understand and am willing to sign the consent form.

Exclusion Criteria

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

I have not been diagnosed with another cancer in the past year.

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic adaptive radiotherapy using an ablatively dosed (50Gy,5fx) for treatment of pancreatic adenocarcinoma

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of GI toxicity and overall survival

12 months

Long-term Follow-up

Participants are monitored for long-term GI toxicities and local control

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Daily Adaptive External Beam Radiation Therapy

Trial Overview The study tests a high-dose radiation therapy called stereotactic adaptive radiotherapy (50Gy in 5 fractions) on patients with pancreatic cancer. It aims to reduce toxicity compared to traditional treatments while assessing survival rates, tumor control, quality of life and the efficiency of the treatment process.

How Is the Trial Designed?

Group I: Daily Adaptive External Beam Radiation Therapy Experimental Treatment 1 Intervention

Daily adaptive radiation therapy delivered with Varian Ethos treatment system

Daily Adaptive External Beam Radiation Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Stereotactic Adaptive Radiation Therapy for:

• Borderline resectable pancreatic cancer
• Locally advanced pancreatic cancer
• Medically inoperable pancreatic adenocarcinoma

Approved in European Union as Stereotactic Adaptive Radiation Therapy for:

• Pancreatic adenocarcinoma
• Locally advanced pancreatic cancer

Who Is Running the Clinical Trial?

Varian, a Siemens Healthineers Company

Lead Sponsor

Trials

35

Recruited

7,200+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

The study demonstrated that online adaptive MR-guided stereotactic body radiation therapy (SBRT) is feasible and well-tolerated in 25 patients with unresectable upper abdominal tumors, with 84% of treatment fractions completed within 60 minutes.

No severe acute toxicity (grade 3 or higher) was reported, and the treatment successfully alleviated pain in 11 out of 13 patients, indicating both safety and efficacy in symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online adaptive MR-guided stereotactic radiotherapy for unresectable malignancies in the upper abdomen using a 1.5T MR-linac. Daamen, LA., de Mol van Otterloo, SR., van Goor, IWJM., et al.[2022]

The first reported case of cone beam CT-guided stereotactic adaptive radiotherapy (CT-STAR) for pancreatic cancer demonstrated successful treatment in a 61-year-old female patient, allowing for precise targeting while minimizing damage to critical organs.

CT-STAR effectively adhered to strict safety constraints, achieving all hard constraints for critical gastrointestinal structures across five treatment fractions, which would have been violated by the initial treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first reported case of a patient with pancreatic cancer treated with cone beam computed tomography-guided stereotactic adaptive radiotherapy (CT-STAR). Kim, M., Schiff, JP., Price, A., et al.[2023]

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]

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]

The first use of stereotactic MR-guided online adaptive radiation therapy (SMART reRT) for reirradiation of locally recurrent pancreatic adenocarcinoma showed promising results, allowing for dose escalation while minimizing damage to nearby gastrointestinal organs.

A 68-year-old patient tolerated the SMART reRT treatment well, receiving 50 Gy in 5 fractions with minimal fatigue, suggesting that this method may enhance the safety and efficacy of reirradiation in sensitive areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic MR-guided online adaptive radiotherapy reirradiation (SMART reRT) for locally recurrent pancreatic adenocarcinoma: A case report. Doty, DG., Chuong, MD., Gomez, AG., et al.[2021]

Citations

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

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) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05764720

NCT05764720 | Stereotactic Adaptive Radiation Therapy ... This trial is a single-arm, prospective, multi-center clinical trial designed to demonstrate that stereotactic adaptive radiotherapy using an ablatively dosed ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9817834/

Stereotactic MR-Guided Adaptive Radiotherapy for ... SMART achieved high secondary resection rates in LAPC patients. Keywords: stereotactic MR-guided adaptive radio therapy (SMART), stereotactic body radiation ...

4. 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6536981/

Using adaptive magnetic resonance image‐guided radiation ... We reviewed 44 patients with inoperable pancreatic cancer treated with MRgRT. Treatments included conventional fractionation, hypofractionation, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12562207/

First Spanish Experience with Stereotactic MR-Guided ... Stereotactic MR-guided adaptive radiotherapy (SMART) may facilitate the delivery of ablative doses of radiation safely with low toxicity. This ...