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Radiation

Stereotactic Ablative Radiosurgery for Lung Cancer (GPS Trial)

N/A
Waitlist Available
Research Sponsored by CancerCare Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult ≥ 18 years of age who is surgically inoperable, or refusing surgical management
Upper lobe tumors are eligible for trial participation if the tumor has a demonstrated tumor motion of ≥1 cm in any axis
Must not have
Tumors located ≤ 2 cm from the proximal bronchial tree
Tumors located < 1cm from the chest wall based on CT imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1,2, and 3 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is for patients with early stage lung cancer or a single pulmonary metastasis. Three tumor locator beacons are placed in the small bronchial airways near the tumors. This allows for smaller treatment volumes of Stereotactic Ablative Radiosurgery (SABR) and more precise delivery of radiotherapy.

Who is the study for?
This trial is for adults over 18 with early-stage Non-Small Cell Lung Cancer or a single lung metastasis who can't have surgery or choose not to. They must be able to undergo bronchoscopy, have decent lung function (DLCO ≥35%, FEV1 ≥0.8L), and an ECOG status of 0-2, indicating they are relatively active. Tumors should be in the middle/lower lobes of the lung but not too close to the chest wall or main airways.
What is being tested?
The study tests a high precision radiotherapy called Stereotactic Ablative Radiosurgery (SABR) using real-time tumor tracking & respiratory gating for treating lung tumors. Patients will have locator beacons placed near their tumors to guide treatment, aiming for greater accuracy and less damage to healthy tissue.
What are the potential side effects?
While specific side effects aren't listed here, SABR treatments like this may cause fatigue, shortness of breath, skin reactions at the treatment site, coughing up blood, and could potentially worsen existing lung conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and cannot or will not have surgery for my condition.
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My upper lobe tumor moves 1 cm or more.
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I can take care of myself and am up and about more than half of my waking hours.
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My lung cancer is in an early stage and located in the middle or lower lobes, or I have a single small lung metastasis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My tumor is close to the main airways in my lungs.
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My tumor is very close to the chest wall, less than 1cm away.
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I cannot lie still or flat for at least 30 minutes.
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My cancer has spread beyond my chest and is not under control.
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My cancer has spread to the lymph nodes in my chest.
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I have received SABR treatment for my tumor.
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I currently have a lung infection.
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I have had lung fibrosis, lung disease not due to specific causes, or active connective tissue disease.
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I need extra oxygen to breathe when I'm resting.
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I am mostly bedridden due to my health condition.
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I have a lung condition affecting airways near my tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1,2, and 3 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1,2, and 3 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean within patient difference in PTV volumes
Secondary study objectives
Acute and late toxicity assessment using the Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Overall Survival
Patient self-reported quality of life
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Real-Time Position Transponder BeaconsExperimental Treatment1 Intervention
Patients in this arm will each be receiving 3 implanted real-time position transponder beacons (Calypso beacons)

Find a Location

Who is running the clinical trial?

CancerCare ManitobaLead Sponsor
28 Previous Clinical Trials
5,612 Total Patients Enrolled
Varian Medical SystemsIndustry Sponsor
62 Previous Clinical Trials
3,724 Total Patients Enrolled

Media Library

Calypso Guided High Precision Stereotactic Ablative Radiosurgery (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT03322072 — N/A
Non-Small Cell Lung Cancer Research Study Groups: Real-Time Position Transponder Beacons
Non-Small Cell Lung Cancer Clinical Trial 2023: Calypso Guided High Precision Stereotactic Ablative Radiosurgery Highlights & Side Effects. Trial Name: NCT03322072 — N/A
Calypso Guided High Precision Stereotactic Ablative Radiosurgery (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03322072 — N/A
~0 spots leftby Jan 2025
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