Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung TUmours Using Real-Time Tumour Tracking & Respiratory Gating (GPS)

This is an interventional treatment trial for Lung Cancer Stage I Read More

Inclusion Criteria:

1. Adult ≥ 18 years of age who is surgically inoperable, or refusing surgical management.

2. Tumor criteria (a patient must satisfy one of "a", "b" below to be eligible):

   1. AJCC 7th edition clinical T1aN0M0, T1bN0M0, or T2aN0M0 (<4cm) Non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, or NSCLC Not Otherwise Specified) of the middle or lower lobes of the lung*;

   2. A single pulmonary metastasis (<4cm) of a known primary malignancy of any histology involving the middle or lower lobes of the lung* (either metastatic failure to a single pulmonary site after primary radical treatment, metastatic progression to a single lung metastasis following palliative chemotherapy, or a single pulmonary metastatic lesion of newly diagnosed stage IV malignancy).

      • upper lobe tumors are eligible for trial participation if the tumor has a demonstrated tumor motion of ≥1 cm in any axis (as assessed by fluoroscopy at the time of bronchoscopy).

3. Confirmation of malignancy (a patient must satisfy one of "a", "b" below to be eligible):

   1. Tumors accessible by bronchoscopy, image-guided percutaneous biopsy, or other invasive staging methods require biopsy confirmation of malignancy.
   2. If a tumor is not amenable to a diagnostic biopsy, evidence of growth of the target tumor on serial imaging scans is necessary prior to enrollment. An increase in SUV of the target tumor on serial PET scans is also acceptable.
4. ECOG performance status of 0 to 2.
5. Minimum life expectancy of 6 months.
6. Deemed fit to undergo bronchoscopy by their participating thoracic surgeon
7. Deemed fit to undergo SABR by their participating Radiation Oncologist.

8. Respiratory function (a patient must satisfy both "a" and "b" below):

   1. Minimum FEV1 of 0.8 liters
   2. Minimum DLCO of 35% predicted.
9. Able to provide written informed consent and understand verbal instructions necessary for radiotherapy treatments.

Exclusion Criteria:

1. Tumors located < 1cm from the chest wall based on CT imaging.
2. Tumors located ≤ 2 cm from the proximal bronchial tree (see figure 7)
3. Patients who require supplemental oxygen at rest.
4. Patients who are unable to lie flat or still for a minimum of 30 minutes.
5. ECOG performance status 3 or 4.
6. Evidence of uncontrolled extra-thoracic metastatic disease (based on imaging or clinical findings).
7. Proven or suspected intrathoracic lymph node involvement.
8. Prior SABR to the target tumor.
9. Prior history of idiopathic pulmonary fibrosis, interstitial lung disease, or active collagen vascular disease (systemic lupus erythematosus, Rheumatoid arthritis, or Scleroderma)
10. Pregnancy.
11. Active pulmonary infection
12. Known hypersensitivity to nickel titanium (Nitinol)
13. Known Bronchiectasis of the small airways nearest to the tumor