- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03322072
Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung TUmours Using Real-Time Tumour Tracking & Respiratory Gating (GPS)
Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung Tumors Using Real-Time Tumor Tracking & Respiratory Gating: A Seamless Phase I/II Prospective Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 thoracic surgeons, radiation oncologists, and medical physicists at CancerCare Manitoba and Health Sciences Center in the use and work flow of the Health Canada approved endobronchial implanted real-time tumor tracking transponder beacons. Patients in phase I will undergo standard stereotactic ablative radiotherapy (SABR) of a lung tumor with prior endobronchial transponder beacon placement. For phase I, the transponder beacons will be used for comparative localization analyses and SABR treatment setup procedures will be carried out independent of transponder beacon data, however, transponder data will be collected in order to conduct, post-treatment, in vivo quality assurance assessments of beacon performance characteristics. Otherwise, the SABR treatment for phase I will consist of the currently accepted standard internal target volume based and standard image guided SABR.
Phase II of this trial will consist of 26 patients who will undergo a specialized form of SABR radiotherapy specifically designed to take full advantage of the real-time tumor tracking ability of the transponder beacons. Specifically, SABR in phase II will consist of smaller radiotherapy treatment volumes employing respiratory gating and smaller planning target volume expansion margins given the superior tumor location telemetry afforded by the beacons. Comparative dosimetric analyses contrasting the traditional ITV/PTV style treatments to those with reduced ITV/PTV margins achieved via Calypso guided SABR will be performed. Patient self-reported quality of life and toxicity assessments will be collected with the goal of facilitating power and sample size calculations for the design of a larger phase III randomized controlled trial of Calypso guided SABR treatment in the future
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julian O Kim, MD
- Phone Number: 204-787-4760
- Email: jkim7@cancercare.mb.ca
Study Contact Backup
- Name: Gordon Buduhan, MD
- Phone Number: 204-787-3109
- Email: gbuduhan@exchange.hsc.mb.ca
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Winnipeg, Manitoba, Canada, R
- Health Sciences Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Real-Time Position Transponder Beacons
Patients in this arm will each be receiving 3 implanted real-time position transponder beacons (Calypso beacons)
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The anchored lung tracking beacons are passive electromagnetic transponder beacons which are placed immediately adjacent to a lung tumor using a bronchoscope.
Three beacons will be placed in the small airways of the lung adjacent to the target tumor (within 3 cm of the tumor).
Each beacon measures 2 mm in diameter and 8 mm in length and consists of a miniature electrical circuit that is encapsulated in a biocompatible glass capsule.
Each beacon has an affixed five-legged anchoring system which expands to 5mm diameter once deployed.
The Calypso transponder beacon is placed endobronchially using the working channel of a bronchoscope.
Navigational bronchoscopy can be used to pre-plan the optimal location for each beacon to be placed within the airways by using a pre-bronchoscopy CT scan.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean within patient difference in PTV volumes
Time Frame: Assessed Immediately prior to RT start
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Mean within patient difference in PTV volumes of standard non-gated SABR treatment compared to PTV volumes of gated SABR using Calypso based PTV margins
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Assessed Immediately prior to RT start
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient self-reported quality of life
Time Frame: 1, 2, and 3 year
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EORTC QLQ - LC13 questionnaire
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1, 2, and 3 year
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Acute and late toxicity assessment using the Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Time Frame: 1, 2, and 3 year
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Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
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1, 2, and 3 year
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RT doses to Thoracic Organs at Risk
Time Frame: Assessed Immediately prior to RT start
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Mean within patient difference in radiotherapy doses to thoracic Organs at risk
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Assessed Immediately prior to RT start
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Tumour Local Control
Time Frame: 1, 2, and 3 year
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Local Control (RECIST version 1.1 criteria)
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1, 2, and 3 year
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Progression Free Survival
Time Frame: 1,2, and 3 year
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Progression Free Survival
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1,2, and 3 year
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Overall Survival
Time Frame: 1,2, and 3 year
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Overall Survival
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1,2, and 3 year
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRIC 2017-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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