Lung Cancer Stage IGPSNCT03322072
Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung TUmours Using Real-Time Tumour Tracking & Respiratory Gating
A study testing Real-Time Position Transponder Beacons in people with Lung Cancer Stage I and Lung Cancer Stage II, run by CancerCare Manitoba at 2 sites in Canada.
Trial 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 (either following radical treatment or systemic therapy) will be offered participation in this study. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer Stage I, Lung Cancer Stage II, Lung Cancer, Nonsmall Cell
- What is being tested?
- Real-Time Position Transponder Beacons
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Nov 2017to 14 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
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- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Health Sciences Center
Winnipeg, Manitoba, R
About this study
Official title: 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
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 (either following radical treatment or systemic therapy) will be offered participation in this study. Participants will have three tumor locator beacons placed with a flexible bronchoscope in the small bronchial airways in proximity (<3cm) from their lung tumors. These tumor locator beacons will provide real-time positional data and will allow for smaller treatment volumes of Stereotactic Ablative Radiosurgery (SABR) and also allow for a specialized form of treatment delivery known as respiratory gated SABR. This is expected to result in higher precision radiotheapy delivery with less radiotherapy dose to healthy tissues which are in close proximity to the lung tumours.
Read the 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
- Conditions
- Lung Cancer Stage I, Lung Cancer Stage II, Lung Cancer, Nonsmall Cell, Lung Cancer Recurrent, Lung Cancer Stage IV
- Being tested
- Real-Time Position Transponder Beacons
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time Position Transponder BeaconsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Real-Time Position Transponder Beacons | Experimental | Patients in this arm will each be receiving 3 implanted real-time position transponder beacons (Calypso beacons) Receives: Device: Real-Time Position Transponder Beacons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean within patient difference in PTV volumes
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
Measured: Assessed Immediately prior to RT start
Secondary outcomes (6)
Patient self-reported quality of life
EORTC QLQ - LC13 questionnaire
Measured: 1, 2, and 3 year
Acute and late toxicity assessment using the Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Measured: 1, 2, and 3 year
RT doses to Thoracic Organs at Risk
Mean within patient difference in radiotherapy doses to thoracic Organs at risk
Measured: Assessed Immediately prior to RT start
Tumour Local Control
Local Control (RECIST version 1.1 criteria)
Measured: 1, 2, and 3 year
Progression Free Survival
Progression Free Survival
Measured: 1,2, and 3 year
Overall Survival
Overall Survival
Measured: 1,2, and 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start23 Nov 2017
- Primary completion14 Jan 2025 (estimated)
- Study completion14 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm prospective cohort study
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CancerCare Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Principal investigator, Dr. Julian Kim, CancerCare Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322072
- Sponsor's protocol ID
- RRIC 2017-014
- Acronym
- GPS
- Status last verified
- Mar 2024
- First submitted
- 17 Oct 2017
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03322072
- Acronym / sponsor ID
- GPS / RRIC 2017-014
- Conditions
- Lung Cancer Stage I, Lung Cancer Stage II, Lung Cancer, Nonsmall Cell, Lung Cancer Recurrent, Lung Cancer Stage IV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- CancerCare ManitobaUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 14 Jan 2025 (estimated)
- Study completion
- 14 Jan 2025 (estimated)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (either following radical treatment or systemic therapy) will be offered participation in this study. Participants will have three tumor locator beacons placed with a flexible bronchoscope in the small bronchial airways in proximity (<3cm) from their lung tumors. These tumor locator beacons will provide real-time positional data and will allow for smaller treatment volumes of Stereotactic Ablative Radiosurgery (SABR) and also allow for a specialized form of treatment delivery known as respiratory gated SABR. This is expected to result in higher precision radiotheapy delivery with less radiotherapy dose to healthy tissues which are in close proximity to the lung tumours.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Real-Time Position Transponder Beacons | Experimental | Device: Real-Time Position Transponder BeaconsPatients in this arm will each be receiving 3 implanted real-time position transponder beacons (Calypso beacons) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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):
- Confirmation of malignancy (a patient must satisfy one of "a", "b" below to be eligible):
- ECOG performance status of 0 to 2.
- Minimum life expectancy of 6 months.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-Time Position Transponder BeaconsThe 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. | Device | Real-Time Position Transponder Beacons |
Primary outcome
Mean within patient difference in PTV volumes
Time frame: Assessed Immediately prior to RT start
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
6 secondary outcomes
Patient self-reported quality of life
Time frame: 1, 2, and 3 year
Acute and late toxicity assessment using the Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Time frame: 1, 2, and 3 year
RT doses to Thoracic Organs at Risk
Time frame: Assessed Immediately prior to RT start
Tumour Local Control
Time frame: 1, 2, and 3 year
Progression Free Survival
Time frame: 1,2, and 3 year
Overall Survival
Time frame: 1,2, and 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time Position Transponder Beacons in people with Lung Cancer Stage I and Lung Cancer Stage II, run by CancerCare Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean within patient difference in PTV volumes (time frame: Assessed Immediately prior to RT start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.