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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

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 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

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

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.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineOTHER
1,976 Previous Clinical Trials
2,290,541 Total Patients Enrolled
Varian, a Siemens Healthineers CompanyLead Sponsor
33 Previous Clinical Trials
7,043 Total Patients Enrolled
Lauren Henke, MDPrincipal InvestigatorCase Western Reserve University

Media Library

Daily Adaptive External Beam Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05764720 — N/A
Pancreatic Cancer Research Study Groups: Daily Adaptive External Beam Radiation Therapy
Pancreatic Cancer Clinical Trial 2023: Daily Adaptive External Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT05764720 — N/A
Daily Adaptive External Beam Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05764720 — N/A
~26 spots leftby Feb 2025