Stereotactic Ablative Radiosurgery for Lung Cancer
(GPS Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: CancerCare Manitoba

No Placebo Group

Trial Summary

What is the purpose of this 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.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

You are expected to live for at least 6 months.

Able to provide written informed consent and understand verbal instructions necessary for radiotherapy treatments

You need to be able to breathe out at least 0.8 liters of air in one second.

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Exclusion Criteria

You are allergic to nickel titanium (Nitinol).

My tumor is close to the main airways in my lungs.

My tumor is very close to the chest wall, less than 1cm away.

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Treatment Details

Interventions

Calypso Guided High Precision Stereotactic Ablative Radiosurgery (Radiation)
Real-Time Position Transponder Beacons (Procedure)

Trial OverviewThe 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.

Participant Groups

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)