Stereotactic Ablative Radiosurgery for Lung Cancer

(GPS Trial)

Not currently recruiting at 1 trial location
GB
JO
Overseen ByJulian O Kim, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: CancerCare Manitoba
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating early-stage lung cancer or single lung tumors from another cancer using a precise form of radiation called Stereotactic Ablative Radiosurgery (SABR). Small beacons placed near the tumor guide the radiation, ensuring it targets the cancer accurately while sparing nearby healthy tissue. This method is known as Calypso Guided High Precision Stereotactic Ablative Radiosurgery. Individuals with small non-small cell lung cancer tumors or a single lung metastasis who cannot or do not want surgery might be suitable candidates. Participants should be able to undergo a procedure called bronchoscopy and have reasonable lung function. As an unphased trial, this study offers patients the chance to explore cutting-edge treatment options that may improve their quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for lung cancer patients?

Research has shown that Calypso-guided radiotherapy, as used in this trial, is generally manageable for patients. Studies indicate that Calypso beacons in Stereotactic Ablative Radiosurgery (SABR) enhance the accuracy of targeting lung tumors. This technique focuses radiation on the tumor while safeguarding surrounding healthy tissue.

One study found that using these beacons in SABR treatments can enhance safety by reducing radiation exposure to healthy tissue. The beacons provide real-time information about the tumor's location, leading to more precise treatment.

Another study reported that SABR achieved a 98% success rate in controlling the primary tumor over three years for early-stage lung cancer, suggesting the treatment is both effective and safe in the long term.

Overall, evidence suggests this approach is a promising and safe option for treating lung cancer.12345

Why are researchers excited about this trial?

Researchers are excited about Calypso Guided High Precision Stereotactic Ablative Radiosurgery for lung cancer because it offers real-time tracking of the tumor during treatment. Unlike traditional radiation therapy, which can sometimes affect healthy tissue due to movement, this method uses implanted transponder beacons to precisely target the cancerous area, minimizing damage to surrounding healthy tissue. This precision not only enhances the effectiveness of the treatment but also reduces side effects, making it a promising option for patients.

What evidence suggests that Calypso Guided High Precision Stereotactic Ablative Radiosurgery is effective for lung cancer?

Research has shown that Stereotactic Ablative Radiosurgery (SABR) effectively treats early-stage Non-Small Cell Lung Cancer. Studies have found that this treatment prevents cancer growth in the treated area for 90% to 96% of patients over three years. SABR has also been associated with better survival rates over five years compared to traditional treatments. In this trial, Calypso beacons, part of the Real-Time Position Transponder Beacons arm, track the tumor's position in real time, allowing for precise targeting. This precision reduces harm to nearby healthy tissues and may enhance the treatment's success.12367

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.
See 8 more

Exclusion Criteria

My tumor is close to the main airways in my lungs.
You are allergic to nickel titanium (Nitinol).
My tumor is very close to the chest wall, less than 1cm away.
See 10 more

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?
1Treatment groups
Experimental Treatment
Group I: Real-Time Position Transponder BeaconsExperimental Treatment1 Intervention

Find a Clinic Near You

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

Citations

Calypso Guided High Precision Stereotactic Ablative ...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...
The GPS TrialSABR of early stage non-small cell lung cancers offers local control rates of the target tumor in the range of 90 to 96% at three years.
Are three doses of stereotactic ablative radiotherapy (SABR ...For stage I non-small-cell lung cancer (NSCLC), surgery alone results typically in a 5-year overall survival (OS) of 60-70% (2). For patients with stage I NSCLC ...
Calypso Guided High Precision Stereotactic Ablative ...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 ...
The first patient treatment of electromagnetic-guided real ...Stereotactic Ablative Body Radiotherapy (SABR) for lesions in the lung has shown substantially improved 5year survival compared to ...
Quality and safety considerations in stereotactic radiosurgery ...The utility of SBRT is perhaps best exemplified in the case of inoperable early-stage lung cancer, where the 3-year primary tumor control rate of 98% is roughly ...
(PDF) Stereotactic Ablative Radiotherapy Using CALYPSO ...(4) Conclusions: SABR for LAPC using Calypso® presented as an effective and safe treatment and could be a promising local therapeutic option ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security