Adaptive Radiation Therapy for Pancreatic Cancer

(ARTIA-Pancreas Trial)

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 precise radiation therapy for patients with difficult-to-remove or inoperable pancreatic cancer. The treatment uses focused radiation to destroy cancer cells while sparing healthy tissue. The study aims to see if this method reduces side effects and improves patient outcomes.

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.

Is adaptive radiation therapy for pancreatic cancer safe for humans?

Research shows that adaptive radiation therapy, including SMART and SBRT, can safely deliver high doses of radiation to pancreatic tumors while minimizing exposure to nearby sensitive organs. This suggests it is generally safe for humans, even in cases of reirradiation. ^{1 2 3 4 5}

What makes the treatment Adaptive Radiation Therapy for Pancreatic Cancer unique?

Adaptive Radiation Therapy for Pancreatic Cancer is unique because it uses advanced imaging techniques like MRI to adjust the radiation dose daily, allowing for precise targeting of the tumor while minimizing damage to nearby sensitive organs. This approach, known as Stereotactic MR-guided Adaptive Radiation Therapy (SMART), is particularly beneficial for inoperable or recurrent pancreatic cancer, offering a safer and more effective treatment option compared to traditional methods. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Adaptive Radiation Therapy for Pancreatic Cancer?

Research shows that stereotactic MR-guided adaptive radiation therapy (SMART) can safely deliver high doses of radiation to pancreatic tumors while protecting nearby sensitive organs. This approach has shown promise in treating inoperable pancreatic cancer and recurrent cases, offering a potential benefit over traditional methods. ^{1 2 3 4 5}

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 pause my current cancer treatment for 1-2 weeks before and after joining CT-STAR.

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

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]

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]

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]

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]

Citations

1. 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]

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

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

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

Stereotactic MR-guided online adaptive radiotherapy reirradiation (SMART reRT) for locally recurrent pancreatic adenocarcinoma: A case report. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Online adaptive MR-guided stereotactic radiotherapy for unresectable malignancies in the upper abdomen using a 1.5T MR-linac. [2022]

6. England 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). [2023]