Clinical Trial 24290

• Overview

  Study 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)

  Summary:

  Recent advancements in radiation technology now allow investigators to adjust a patient’s radiation treatment plan at each radiation visit to account for daily changes in their tumor as well as any changes in stomach filling and bowel position that may occur day-to-day. This approach is known as “adaptive radiotherapy.” By using adaptive radiotherapy, it may be possible to lower the radiation dose to normal tissues while still safely giving high dose radiation to pancreatic tumors. The investigational part of this study is to evaluate the potential benefit of adaptive radiotherapy in reducing upper gastrointestinal symptoms that may arise from radiation treatment as well as overall quality of life.

  Objective:

  Primary Objective: - To evaluate the rate of acute (90 day) Grade 3+ toxicity using ablatively dosed (50Gy/5fx) CT-STAR for BR/LAPC, compared to historic control rates. We hypothesize that CT-STAR will reduce acute Grade 3+ GI toxicity, with a 10% effect size, from a 20% historic rate. Secondary Objective: - To evaluate the rate of long term (12 month) Grade 3+ toxicity using ablatively dosed (50Gy/5fx) CT-STAR for BR/LAPC, compared to historic control rates. We hypothesize that CT-STAR will reduce long term Grade 3+ GI toxicity, with a 15% effect size, from a 25% historic rate (key powered secondary endpoint) - Evaluate overall survival at one- and two-years-post-completion of CT-STAR - Evaluate local (in-field) control rates at one- and two-years-post-completion of CT-STAR - Evaluate distant-progression-free survival at one- and two-years-post-completion of CT-STAR

• Treatments

  Therapies:

  Radiotherapy

  Medications:

  Radiotherapy ()

• Inclusion Criteria

  Inclusion Criteria:
  • Histologically or cytologically confirmed borderline-resectable (based on NCCN criteria), locally-advanced (based on NCCN criteria), or medically inoperable pancreatic adenocarcinoma.
  • ECOG performance status 0-1
  • 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.
  • 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.
  • At least 18 years of age.
  • 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).
  • 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.
  • Anatomy of target and adjacent OARs adequately visualized on ETHOS simulation imaging, as determined by treating and study physicians.
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Past history of radiotherapy within the projected treatment field
  • Prior, intercurrent, or planned receipt (within 90 days prior to or following SBRT) of any investigational agents related to pancreatic cancer diagnosis.
  • 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.
  • Gross tumor invasion of the stomach or duodenum (defined either radiographically or endoscopically).
  • Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  • Other criteria may apply

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