What side effects are associated with this type of intervention?

Stereotactic Adaptive Radiotherapy (SART) for pancreatic cancer aims to minimize damage to healthy tissue while delivering high-dose radiation to the tumor. Common side effects include gastrointestinal issues like nausea, vomiting, and diarrhea, as well as fatigue and skin reactions at the treatment site. When combined with systemic treatments like chemotherapy, additional side effects may include hand-foot syndrome, increased risk of infections, and further gastrointestinal disturbances.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including chemotherapy agents like gemcitabine and nab-paclitaxel, as well as targeted therapies such as erlotinib. While specific FDA approvals for Stereotactic Adaptive Radiotherapy (SART) are not detailed, stereotactic body radiotherapy (SBRT), a similar high-precision radiation technique, is an emerging treatment modality. SBRT delivers high doses of radiation to the tumor while sparing surrounding healthy tissue, aligning with the principles of SART.

What other types of research exist?

Promising novel alternatives to Stereotactic Adaptive Radiotherapy for pancreatic cancer patients include: 1) Immunotherapy, particularly immune checkpoint inhibitors, which have shown potential in enhancing the body's immune response against cancer cells. 2) Targeted therapies, such as PARP inhibitors for patients with specific genetic mutations (e.g., BRCA1/2). 3) Combination therapies that integrate chemotherapy with novel agents to improve efficacy. 4) Advanced radiation techniques like Magnetic Resonance Imaging-Guided Radiation Therapy (MRIgRT), which offers precise targeting of tumors with real-time imaging. These alternatives are being actively researched and may offer new hope for pancreatic cancer patients in 2024.

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Radiation Therapy

Adaptive Radiation Therapy for Pancreatic Cancer (ARTIA-Pancreas Trial)

N/A

Recruiting

Led By Lauren Henke, MD

Research Sponsored by Varian, a Siemens Healthineers Company

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed borderline-resectable (based on NCCN criteria), locally-advanced (based on NCCN criteria), or medically inoperable pancreatic adenocarcinoma

At least 18 years of age

Must not have

Competing, active cancer diagnosis within the preceding one year

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 90 days from start of treatment

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While aiming for decreased toxicity, potential side effects may include gastrointestinal issues due to radiation exposure such as nausea or diarrhea. The precise side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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My pancreatic cancer is advanced but not yet widely spread.

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I am 18 years old or older.

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I can hold my breath for at least 20 seconds once and 10 seconds repeatedly on command.

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My initial treatment plan and imaging will be reviewed by the study's lead doctors.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have had radiation treatment in the area where I will be treated again.

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I haven't taken, nor plan to take, experimental drugs for pancreatic cancer around my SBRT treatment.

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My cancer has spread to my stomach or duodenum.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 90 days from start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 90 days from start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 90 days from start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute Grade 3+ treatment related GI toxicities

Secondary study objectives

Local in-field Control

Long Term Grade 3+ treatment related GI toxicities

Overall Survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Daily Adaptive External Beam Radiation TherapyExperimental Treatment1 Intervention

Daily adaptive radiation therapy delivered with Varian Ethos treatment system

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for pancreatic cancer include stereotactic adaptive radiotherapy (SART), chemotherapy, and investigational therapies. SART delivers precise, high-dose radiation to the tumor while sparing healthy tissue, which is essential for reducing side effects and improving patient quality of life. Chemotherapy targets rapidly dividing cancer cells but can also affect healthy cells, leading to broader side effects. Investigational therapies like ONC201 target specific molecular pathways involved in cancer cell survival and stress responses. Understanding these mechanisms helps tailor treatments to the tumor's characteristics and the patient's overall health, optimizing outcomes.