Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03322072
Study type Interventional
Source CancerCare Manitoba
Contact
Status Active, not recruiting
Phase N/A
Start date November 23, 2017
Completion date January 14, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT06003075 - Induction Chemo-Nivo in Unresectable Stage III NSCLC Phase 2
Enrolling by invitation NCT06293833 - Implementation of Lung Cancer Screening in the First Line Zone of ZORA (Flanders), Using a Low Dose CT-scan N/A
Recruiting NCT03705806 - Palliative Thoracic ImmunoRT
Not yet recruiting NCT06060964 - Enabling Remote Access to Breathe Easier: A Novel Approach to Improve Symptom Management Early Phase 1
Completed NCT04634630 - The Influence of Cancer Stem-cells on Risk of Relapse in Patients Harboring Adenocarcinoma and Squamous Cell Carcinoma of the Lung
Completed NCT03689634 - Move For Surgery - A Novel Preconditioning Program Phase 3
Recruiting NCT05537922 - I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
Completed NCT03902834 - Move for Surgery (MFS): Evaluating the Use of Wearable Technology for Preconditioning Before Thoracic Surgery N/A
Completed NCT02995889 - FLT-PET for Early Detection of Relapse in Patients With Irradiated Lung Cancer N/A
Recruiting NCT04237805 - A Phase I/II Clinical Study of SAF-189s in Non-small Cell Lung Cancer (NSCLC) Patients Phase 1/Phase 2
Terminated NCT05061940 - This SCR-103 Protocol Will Permit Sites to Proactively Assess TAA, HLA and HPV-16 Status in Patients With Selected Solid Tumors to Determine Suitability for Repertoire Immune Medicines Treatment Protocols.
Recruiting NCT05860296 - Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers Phase 1/Phase 2
Suspended NCT02991651 - Study of IRX4204 With Erlotinib in Previously Treated Advanced NSCLC Phase 1
Enrolling by invitation NCT04678440 - [18F]F-AraG/Total Body PET Imaging and Healthy Subjects and Lung Cancer Patients Early Phase 1
Recruiting NCT04222335 - Understanding and Overcoming the Early Adaptive Resistance to EGFR Tyrosine-kinase Inhibitors in Lung Cancer Patients N/A
Recruiting NCT04415320 - X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases Phase 2
Recruiting NCT02786589 - Plasmodium Immunotherapy for Lung Cancer Phase 1/Phase 2
Recruiting NCT05085028 - A Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Phase 3
Completed NCT05956782 - Breathe Easier II: A Dyad-based Multiple Behavior Intervention N/A
Enrolling by invitation NCT05863013 - Use of the ADL-Glittre Test in the Pre and Postoperative Period of Patients With Lung Cancer N/A