Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03322072
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Varian Medical Systems
Information provided by (Responsible Party):
Dr. Julian Kim, CancerCare Manitoba

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 (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.

Condition or disease Intervention/treatment Phase
Lung Cancer Stage I Lung Cancer Stage II Lung Cancer, Nonsmall Cell Lung Cancer Recurrent Lung Cancer Stage IV Device: Real-Time Position Transponder Beacons Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm prospective cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 23, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


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)
Device: Real-Time Position Transponder Beacons
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Patient self-reported quality of life [ Time Frame: 1, 2, and 3 year ]
    EORTC QLQ - LC13 questionnaire

  2. Acute and late toxicity assessment using the Common Terminology Criteria for Adverse Events (CTCAE version 4.0) [ Time Frame: 1, 2, and 3 year ]
    Common Terminology Criteria for Adverse Events (CTCAE version 4.0)

  3. RT doses to Thoracic Organs at Risk [ Time Frame: Assessed Immediately prior to RT start ]
    Mean within patient difference in radiotherapy doses to thoracic Organs at risk

  4. Tumour Local Control [ Time Frame: 1, 2, and 3 year ]
    Local Control (RECIST version 1.1 criteria)

  5. Progression Free Survival [ Time Frame: 1,2, and 3 year ]
    Progression Free Survival

  6. Overall Survival [ Time Frame: 1,2, and 3 year ]
    Overall Survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322072


Contacts
Layout table for location contacts
Contact: Julian O Kim, MD 204-787-4760 jkim7@cancercare.mb.ca
Contact: Gordon Buduhan, MD 204-787-3109 gbuduhan@exchange.hsc.mb.ca

Locations
Layout table for location information
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Julian O Kim, MD    1-204-787-4760    jkim7@cancercare.mb.ca   
Health Sciences Center Recruiting
Winnipeg, Manitoba, Canada, R
Contact: Gordon Buduhan, MD    1-204-787-3109    gbuduhan@exchange.hsc.mb.ca   
Sponsors and Collaborators
CancerCare Manitoba
Varian Medical Systems
  Study Documents (Full-Text)

Documents provided by Dr. Julian Kim, CancerCare Manitoba:
Layout table for additonal information
Responsible Party: Dr. Julian Kim, Assistant Professor, CancerCare Manitoba
ClinicalTrials.gov Identifier: NCT03322072    
Other Study ID Numbers: RRIC 2017-014
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms