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

Recruiting in Palo Alto (17 mi)

Overseen by Arya Amini

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: City of Hope Medical Center

Must be taking: Checkpoint inhibitors

Disqualifiers: Pregnancy, Breastfeeding, Non-compliance, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

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.

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}

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

Trial 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 (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, Australia 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

🇦🇺 Approved in Australia as Stereotactic Body Radiation Therapy for:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

City of Hope Medical Center Duarte, CA

Who Is Running the Clinical Trial?

City of Hope Medical Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

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

CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022] Stereotactic ablative radiotherapy (SABR) has emerged as a promising treatment for early stage non-small cell lung cancer, particularly for patients unable to tolerate surgical resection. High rates of local tumor control have been demonstrated with acceptable toxicity and the practical advantage of a short course of treatment. The CyberKnife image-guided robotic radiosurgery system has unique technical characteristics that make it well suited for SABR of tumors that move with breathing, including lung tumors. We review the qualities of the CyberKnife platform for lung tumor SABR, and provide a summary of clinical data using this system specifically.

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] Fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT) is gaining evidence as a predictive factor in non-small cell lung cancer (NSCLC). Stereotactic ablative radiotherapy (SABR) is the standard treatment in early-stage NSCLC when a patient is unsuitable for surgery. We performed a study to assess the prognostic clinical significance of PET-CT after SABR in early-stage NSCLC.

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] Stereotactic ablative body radiotherapy (SABR) is emerging as a non-invasive method for precision irradiation of lung tumours. However, the ideal dose/fractionation schedule is not yet known. The primary purpose of this study is to assess safety and efficacy profile of single and multi-fraction SABR in the context of pulmonary oligometastases.

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] Stereotactic ablative body radiotherapy (SABR) provides a superior non-small cell lung cancer (NSCLC) treatment option when compared to conventional radiotherapy for patients deemed inoperable or refusing surgery. This study retrospectively analyzed the rates of tumor control and toxicity following SABR treatment (Cyberknife system) of primary early-stage NSCLC in a community setting.

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

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022] We evaluated the effectiveness and safety of stereotactic ablative radiotherapy (SABR) delivered using Cyberknife in patients with stage I non-small-cell lung cancer.

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

Risk-adapted robotic stereotactic body radiation therapy for inoperable early-stage non-small-cell lung cancer. [2022] To evaluate efficacy and toxicity of stereotactic body radiation therapy (SBRT) with CyberKnife® (Accuray, Sunnyvale, CA, USA) in a selected cohort of primary, medically inoperable early-stage non-small cell lung cancer (NSCLC) patients.

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

Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. [2023] The CyberKnife system features a robotically-positioned linear accelerator to deliver real-time image-guided stereotactic ablative body radiotherapy (SABR). It achieves steep dose gradients using irradiation from hundreds of different directions and increases the central dose of the gross tumor volume (GTV) without increasing the marginal dose to the planning target volume. We evaluated the effectiveness and safety of SABR with a central high dose using CyberKnife for metastatic lung tumors.

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

In silico comparison of photons versus carbon ions in single fraction therapy of lung cancer. [2017] Stereotactic body image guided radiation therapy (SBRT) shows good results for lung cancer treatment. Better normal tissue sparing might be achieved with scanned carbon ion therapy (PT). Therefore an in silico trial was conducted to find potential advantages of and patients suited for PT.

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

The role of positron emission tomography following radiosurgical treatment of malignant lung lesions. [2016] To establish response patterns in PET following stereotactic body radiotherapy (SBRT) of malignant lung lesions.

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

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017] Stereotactic body radiation therapy (SBRT, also called stereotactic ablative body radiation SABR) is the treatment of choice for many patients with early-stage non-small cell lung cancer (NSCLC), including those who are unfit for surgery or refuse surgery.