Stereotactic Ablative Radiosurgery for Lung Cancer

(GPS Trial)

Recruiting at 1 trial location

Overseen By Julian O Kim, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CancerCare Manitoba

Disqualifiers: Supplemental oxygen, Uncontrolled metastasis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

28 Participants Needed

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Quality assurance assessments and familiarization with the use of endobronchial implanted real-time tumor tracking transponder beacons. Standard SABR treatment with beacon data collection for post-treatment quality assurance.

4 weeks

Multiple visits for beacon placement and SABR treatment

Phase II Treatment

Specialized SABR radiotherapy using real-time tumor tracking with transponder beacons, employing respiratory gating and smaller planning target volume expansion margins.

8 weeks

Multiple visits for SABR treatment

Follow-up

Participants are monitored for safety, effectiveness, and quality of life post-treatment. Includes toxicity assessments and tumor control evaluations.

3 years

Regular follow-up visits at 1, 2, and 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Calypso Guided High Precision Stereotactic Ablative Radiosurgery
• Real-Time Position Transponder Beacons

Trial Overview 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.

How Is the Trial Designed?

Group I: Real-Time Position Transponder Beacons Experimental Treatment 1 Intervention

Patients in this arm will each be receiving 3 implanted real-time position transponder beacons (Calypso beacons)

Who Is Running the Clinical Trial?

CancerCare Manitoba

Lead Sponsor

Trials

29

Recruited

5,600+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester