About this trial

This phase II trial tests the effectiveness and safety of artificial intelligence (AI) to determine dose recommendation during stereotactic body radiation therapy (SBRT) planning in patients with primary lung cancer or tumors that has spread from another primary site to the lung (metastatic). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Even with the high precision of SBRT, disease persistence or reappearance (local recurrence) can still occur, which could be attributed to the radiation dose. AI has been used in other areas of healthcare to automate and improve various aspects of medical science. Because the relationship of dose and local recurrence indicates that dose prescriptions matter, decision support systems to help guide dose based on personalized prediction AI algorithms could better assist providers in prescribing the radiation dose of lung stereotactic body radiation therapy treatment.

Eligibility criteria

Qualifiers

Patients with radiographic findings consistent with lung cancer or solitary or oligometastatic disease in the lung. Most patients will have primary non-small cell lung cancer. For primary lung cancers, we include lesions with ground glass opacities with a solid component of 50% or greater. Patients with solitary or oligo-metastatic disease in the lung may have any other histology or cancer type.

Patients must have radiographically measurable or evaluable disease per RECIST v. 1.1.

Patients must be age >= 18 years.

Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Disqualifiers

Patients who have had prior radiotherapy with radiation field overlap.

For primary lung cancers, patients with ground glass opacities without a solid component will be excluded.

Patients who have not recovered from adverse events confined to the thorax (i.e. pneumonitis, bronchial insufficiency, bronchial hemorrhage, esophagitis) due to prior anticancer therapy (i.e., have residual toxicities >= grade 2) with the exception of alopecia. low blood counts (neutropenia, anemia, etc), or anatomically distinct toxicities (i.e. cystitis).

Patients who are receiving any other concurrent investigational agents or genotoxic chemotherapy for cancer treatment.

Trial design

Treatments tested in this trial

  • Computed Tomography
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Quality-of-Life Assessment
  • Radiology, Treatment Planning
  • Stereotactic Body Radiation Therapy
  • X-Ray Imaging

Treatment groups

70 Participants
are divided into 1 treatment group

Locations

1
Northwestern University60611, ChicagoIllinois, United States

Sponsors and collaborators

Northwestern University

Lead sponsor

Varian Medical Systems

Collaborator

National Cancer Institute (NCI)

Collaborator