Stereotactic Adaptive Radiation Therapy of Borderline Resectable Pancreatic Cancer an Individualized Approach

Pancreatic Cancer Clinical Trial

— ARTIA-Pancreas  

Official title:

A Prospective Trial of Stereotactic Adaptive Radiation Therapy for Borderline Resectable/Locally Advanced Pancreatic Cancer: An Individualized Approach to Minimizing Gastrointestinal Toxicity (ARTIA-Pancreas)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764720
• Other study ID #: VAR-2021-07
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2023
• Est. completion date: February 15, 2027

Study information

• Verified date: September 2023
• Source: Varian, a Siemens Healthineers Company
• Contact: Steve Kohlmyer
• Phone: 12628805099
• Email: steve.kohlmyer[@]varian.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is a single-arm, prospective, multi-center clinical trial designed to demonstrate that stereotactic adaptive radiotherapy using an ablatively dosed (50Gy,5fx) for treatment of borderline-resectable, locally-advanced , or medically inoperable pancreatic adenocarcinoma will translate into a decreased toxicity. The study will evaluate GI toxicity, overall survival, local control, quality of life, and workflow metrics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: February 15, 2027
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

2. ECOG performance status 0-1

3. Receipt of at least two months of lead-in chemotherapy (regimen at the discretion of the treating physician) prior to planned initiation of CT-STAR.

4. Limited regional lymphadenopathy permitted. Node positive patients are restricted to those with up to 3 clinically involved (greater than 1cm on cross-sectional imaging or pathologically proven) nodes provided that the lymph nodes are adjacent to the primary tumor.

5. At least 18 years of age.

6. Must be able to take an interruption in systemic therapy at least one week prior to planned start of CT-STAR (two weeks preferred) lasting for the duration of CT-STAR and continuing for at least one week following end of CT-STAR (two weeks preferred).

7. Capable of a single end-exhale breath-hold of at least 20 seconds in duration and of repeated end-exhale or deep inspiratory breath-hold of at least 10 seconds in duration upon verbal instruction.

8. Anatomy of target and adjacent OARs adequately visualized on ETHOS simulation imaging, as determined by treating and study physicians. Note: central review of simulation imaging and initial plan target/OAR contours by the Principal Investigator and Physics lead is required for the first two patients at each participating institution prior to study treatment delivery. Patients with inadequate anatomic visualization at simulation will be considered screen-failures and treated off-protocol as per institutional standard-of-care.

9. Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

1. Past history of radiotherapy within the projected treatment field

2. Prior, intercurrent, or planned receipt (within 90 days prior to or following SBRT) of any investigational agents related to pancreatic cancer diagnosis.

3. Competing, active cancer diagnosis within the preceding one year.

4. 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.

5. Gross tumor invasion of the stomach or duodenum (defined either radiographically or endoscopically).

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• Daily Adaptive External Beam Radiation Therapy
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.

Locations

Country	Name	City	State
United States	Washington University, St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Varian, a Siemens Healthineers Company	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Grade 3+ treatment related GI toxicities	The rate of acute Grade 3 or higher treatment related GI toxicities using CTCAE version 5.0 criteria	Within 90 days from start of treatment
Secondary	Long Term Grade 3+ treatment related GI toxicities	The rate of long term Grade 3 or higher treatment related GI toxicities, using CTCAE version 5.0 criteria	12 months after completion of external beam radiation treatment
Secondary	Overall Survival	Kaplan-Meier estimates of the rates of overall survival	One and two years after completion of external beam radiation treatment
Secondary	Local in-field Control	Local (in-field) control rates defined as stable disease, partial response, or complete response by RECIST criteria	One and two years after completion of external beam radiation treatment
Secondary	Progression Free Survival	Kaplan-Meier estimates of distant-progression-free survival	One and two years after completion of external beam radiation treatment