SBRT Guided by PET Scans for Non-Small Cell Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must be taking: Checkpoint inhibitors

Disqualifiers: Pregnancy, Breastfeeding, Non-compliance, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 5 weeks

32 Participants Needed

Trial Summary

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. Please consult with the study team for guidance.

What data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy, Stereotactic Ablative Radiotherapy (SABR), CyberKnife for Non-Small Cell Lung Cancer?

Research shows that SABR, especially using the CyberKnife system, is effective for treating early-stage non-small cell lung cancer, offering high rates of local tumor control with manageable side effects. It is particularly beneficial for patients who cannot undergo surgery, providing a precise and non-invasive treatment option. ^{1 2 3 4 5}

Is SBRT using CyberKnife safe for treating non-small cell lung cancer?

Studies show that using CyberKnife for stereotactic body radiation therapy (SBRT) in non-small cell lung cancer is generally safe, with acceptable levels of side effects and good control of the tumor. ^{1 4 5 6 7}

How is SBRT guided by PET scans different from other treatments for non-small cell lung cancer?

SBRT (Stereotactic Body Radiation Therapy) is a precise form of radiation treatment that targets lung tumors with high doses in fewer sessions, making it ideal for patients who cannot undergo surgery. The use of PET scans (a type of imaging test) to guide SBRT helps in accurately targeting the tumor, potentially improving treatment outcomes and minimizing damage to surrounding healthy tissue. ^{1 4 8 9 10}

What is the purpose of this trial?

This phase II trial tests the safety of positron emission tomography (PET) guided stereotactic body radiation therapy (SBRT) and how well it works to treat non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma (RCC) that has up to 5 sites of progression (oligoprogression) compared to standard SBRT. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. A PET scan is an imaging test that looks at your tissues and organs using a small amount of a radioactive substance. It also checks for cancer and may help find cancer remaining in areas already treated. Using a PET scan for SBRT planning may help increase the dose of radiation given to the most resistant part of the cancer in patients with oligoprogressive NSCLC, melanoma, and RCC.

Research Team

Arya Amini

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults with certain cancers (NSCLC, melanoma, RCC) that have spread to up to 5 places. Patients must have had prior treatment and controlled primary tumor for over 3 months or be treated with intent to control. They need a life expectancy of at least 3 months and be able to undergo PET/CT scans.

Inclusion Criteria

Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study principal investigator (PI) approval

Assent, when appropriate, will be obtained per institutional guidelines

My cancer spots can be treated with focused radiation and are at least 1 cm big.

Exclusion Criteria

A radiation oncologist determined I can't have SBRT.

I am not pregnant or breastfeeding and have a negative pregnancy test.

Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo SBRT treatments every other day, with PET/CT and blood collection throughout the study

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular assessments at 3, 6, and 12 months

Extension/Long-term follow-up

Participants are monitored for long-term outcomes such as quality of life and adverse events

Up to 12 months

Treatment Details

Interventions

• Stereotactic Body Radiation Therapy

Trial Overview The trial tests PET-guided SBRT's safety and effectiveness in treating oligoprogressive cancer compared to standard SBRT. It aims to deliver precise radiation doses while minimizing damage to healthy tissue by using advanced imaging techniques.

Participant Groups

Group I: ARM II: (PET guided SBRT) Experimental Treatment 5 Interventions

ARM II: Patients undergo 3 SBRT treatments every other day week 1, undergo PET/CT and replanning one month post SBRT, then undergo 2 additional treatments with SIB on study. Patients also undergo CT or PET/CT and blood collection throughout study.

Group II: ARM I: (standard care SBRT) Experimental Treatment 5 Interventions

Patients undergo 5 SBRT treatments every other day on study. Patients also undergo CT or PET/CT and blood collection throughout study.

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[2022]

In a study of 76 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative radiotherapy (SABR), the local control rates were high, with 95.9% at 1 year and 86.7% at 5 years, indicating SABR is an effective treatment option for this patient group.

The pre-treatment maximum standardized uptake value (SUVmax) from PET-CT scans was found to be a significant predictor of overall survival, with higher SUVmax values (above 6) correlating with worse outcomes, suggesting that PET-CT can help identify patients at higher risk for poor prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SUVmax Predicts Disease Progression after Stereotactic Ablative Radiotherapy in Stage I Non-small Cell Lung Cancer. Kwak, YK., Park, HH., Choi, KH., et al.[2022]

The TROG 13.01/ALTG 13.001 clinical trial is investigating the safety and efficacy of single versus multi-fraction stereotactic ablative body radiotherapy (SABR) for lung tumors in 84 patients with up to three metastases, aiming to determine the best treatment approach for pulmonary oligometastases.

The study will compare a single high dose of 28Gy to a total of 48Gy delivered in four fractions, assessing not only safety but also quality of life, survival rates, and potential cost implications of each treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II). Siva, S., Kron, T., Bressel, M., et al.[2022]

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

In a study of 106 patients with early-stage non-small cell lung cancer treated with CyberKnife® SBRT, the treatment demonstrated an 88% local control rate at 2 years, indicating its efficacy in managing this type of cancer.

The treatment was associated with low toxicity, with only 20% of patients experiencing mild fatigue and 17% mild dyspnea, and only 4% experiencing significant late effects, suggesting it is a safe option for medically inoperable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-adapted robotic stereotactic body radiation therapy for inoperable early-stage non-small-cell lung cancer. Temming, S., Kocher, M., Stoelben, E., et al.[2022]

In a study of 73 patients with metastatic lung tumors treated using the CyberKnife system, stereotactic ablative body radiotherapy (SABR) demonstrated high effectiveness, achieving a 2-year local control rate of 89.1% and an overall survival rate of 71.3%.

The treatment was associated with acceptable toxicity levels, with only two cases of grade 2 or higher radiation pneumonitis, indicating that SABR with a central high dose is a safe option for managing metastatic lung tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2023]

Scanned carbon ion therapy (PT) offers better sparing of normal tissues compared to stereotactic body radiation therapy (SBRT), with lower doses to critical organs at risk (OARs) while maintaining the same coverage of the cancer target area in 19 lung cancer patients.

Patients with larger tumor volumes (CTV >2.5cc) or multiple lung lesions benefit the most from PT, as they experience significantly reduced radiation exposure to vital organs like the heart and spinal cord.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In silico comparison of photons versus carbon ions in single fraction therapy of lung cancer. Anderle, K., Stroom, J., Pimentel, N., et al.[2017]

In a study of 39 patients with malignant lung lesions treated with stereotactic body radiotherapy (SBRT), significant changes in the maximum standardized uptake value (SUVmax) were observed, particularly a marked decrease in primary lesions after 6 months, indicating a positive response to treatment.

Metastatic lesions showed more variability in SUVmax, with initial increases followed by decreases after 6 months; however, local failures were associated with higher SUVmax and size changes, complicating the interpretation of PET scans due to potential fibrotic changes in surrounding tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of positron emission tomography following radiosurgical treatment of malignant lung lesions. Gill, BS., Rivandi, AH., Sandhu, SP., et al.[2016]

Stereotactic body radiation therapy (SBRT) is a preferred treatment for early-stage non-small cell lung cancer (NSCLC) patients who cannot undergo surgery, but accurate lymph node staging is crucial for optimal patient selection.

Current staging methods like PET/CT and EBUS have limited sensitivity in detecting lymph node metastases, which can lead to undetected cancer spread and poorer outcomes; thus, invasive staging procedures are often necessary to improve detection and potentially enhance survival with adjuvant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. Cerra-Franco, A., Diab, K., Lautenschlaeger, T.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

SUVmax Predicts Disease Progression after Stereotactic Ablative Radiotherapy in Stage I Non-small Cell Lung Cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II). [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. [2020]

5. Greece pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Risk-adapted robotic stereotactic body radiation therapy for inoperable early-stage non-small-cell lung cancer. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

In silico comparison of photons versus carbon ions in single fraction therapy of lung cancer. [2017]

9. England pubmed.ncbi.nlm.nih.gov

The role of positron emission tomography following radiosurgical treatment of malignant lung lesions. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017]