Status:
ACTIVE_NOT_RECRUITING
Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung TUmours Using Real-Time Tumour Tracking & Respiratory Gating
Lead Sponsor:
CancerCare Manitoba
Collaborating Sponsors:
Varian Medical Systems
Conditions:
Lung Cancer Stage I
Lung Cancer Stage II
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This is a single arm seamless phase I/II prospective cohort study. Patients with early stage Non-Small Cell Lung Cancer (T1-T2N0M0) or those with a single pulmonary metastasis of a known malignancy (e...
Detailed Description
This trial is a seamless phase I/II prospective, single arm, cohort study. Phase I of the trial will consist of two patients and will serve to conduct quality assurance assessments and to familiarize...
Eligibility Criteria
Inclusion
- Adult ≥ 18 years of age who is surgically inoperable, or refusing surgical management.
- Tumor criteria (a patient must satisfy one of "a", "b" below to be eligible):
- 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\*;
- 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).
- Confirmation of malignancy (a patient must satisfy one of "a", "b" below to be eligible):
- Tumors accessible by bronchoscopy, image-guided percutaneous biopsy, or other invasive staging methods require biopsy confirmation of malignancy.
- 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.
- ECOG performance status of 0 to 2.
- Minimum life expectancy of 6 months.
- Deemed fit to undergo bronchoscopy by their participating thoracic surgeon
- Deemed fit to undergo SABR by their participating Radiation Oncologist.
- Respiratory function (a patient must satisfy both "a" and "b" below):
- Minimum FEV1 of 0.8 liters
- Minimum DLCO of 35% predicted.
- Able to provide written informed consent and understand verbal instructions necessary for radiotherapy treatments.
Exclusion
- Tumors located \< 1cm from the chest wall based on CT imaging.
- Tumors located ≤ 2 cm from the proximal bronchial tree (see figure 7)
- Patients who require supplemental oxygen at rest.
- Patients who are unable to lie flat or still for a minimum of 30 minutes.
- ECOG performance status 3 or 4.
- Evidence of uncontrolled extra-thoracic metastatic disease (based on imaging or clinical findings).
- Proven or suspected intrathoracic lymph node involvement.
- Prior SABR to the target tumor.
- Prior history of idiopathic pulmonary fibrosis, interstitial lung disease, or active collagen vascular disease (systemic lupus erythematosus, Rheumatoid arthritis, or Scleroderma)
- Pregnancy.
- Active pulmonary infection
- Known hypersensitivity to nickel titanium (Nitinol)
- Known Bronchiectasis of the small airways nearest to the tumor
Key Trial Info
Start Date :
November 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 14 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03322072
Start Date
November 23 2017
End Date
January 14 2025
Last Update
March 20 2024
Active Locations (2)
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1
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
2
Health Sciences Center
Winnipeg, Manitoba, Canada, R