Adaptive Radiation Therapy for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Salma Jabbour, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Immunotherapy

Must not be taking: Investigational agents

Disqualifiers: CNS metastases, Active second cancers, others

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies whether updating the radiation treatment plan can reduce side effects in patients with advanced lung cancer. The goal is to better target the tumor while protecting healthy tissue.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of this treatment for non-small cell lung cancer?

Research shows that stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT), is effective for treating early-stage non-small cell lung cancer (NSCLC), especially in patients who cannot undergo surgery. SABR provides high precision radiation, leading to tumor control rates and side effects similar to those of surgical removal, making it a valuable non-invasive treatment option. ^{1 2 3 4 5}

Is adaptive radiation therapy for non-small cell lung cancer safe for humans?

Stereotactic ablative radiotherapy (SABR), a form of adaptive radiation therapy, is generally considered safe for treating non-small cell lung cancer, with toxicity levels comparable to surgical options. Studies have shown it to be a standard treatment for early-stage lung cancer, with careful implementation ensuring safety and quality of life. ^{2 3 4 6 7}

How is adaptive radiation therapy different from other treatments for non-small cell lung cancer?

Adaptive radiation therapy, specifically using stereotactic body radiation therapy (SBRT) or stereotactic ablative radiotherapy (SABR), is unique because it delivers high doses of radiation precisely to the tumor, minimizing damage to surrounding healthy tissue. This makes it particularly effective for early-stage non-small cell lung cancer (NSCLC) and suitable for patients who cannot undergo surgery. ^{1 5 8 9 10}

Research Team

Salma Jabbour, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

This trial is for adults with stage II-IV non-small cell lung cancer who are in good physical condition (ECOG 0 or 1) and have not had prior treatments other than specific chemoradiation. They must be able to use effective contraception, provide consent, and have no other health issues that could affect the study.

Inclusion Criteria

Women who could become pregnant must have a negative pregnancy test before starting the study.

I am a man and use highly effective birth control if having sex with a woman who can get pregnant.

My lung cancer is at an advanced stage but planned to be treated with specific therapies.

Exclusion Criteria

I have another type of cancer that is currently active.

I've had lung cancer treatment but not more than 2 rounds after chemoradiation.

History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the site investigator

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Simulation

Patients undergo CT simulation with or without IV contrast to prepare for radiation treatment

2 weeks

1 visit (in-person)

Treatment

Patients undergo standard of care chemoradiation and adaptive radiation planning

6 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3-12 weeks, then every 6 months for 2 years

Regular visits (in-person)

Treatment Details

Interventions

• Radiation Treatment (Radiation Therapy)

Trial Overview The trial tests whether adaptive radiation planning can reduce side effects from radiation treatment and immunotherapy. It involves adjusting the radiation plan at set intervals based on tumor size changes during treatment to minimize exposure to healthy tissue.

Participant Groups

Group I: Supportive care (CT simulation, contrast agent) Experimental Treatment 2 Interventions

Patients undergo CT stimulation with or without IV contrast over 1.5 hours on days -15 to -1, then undergo SOC chemoradiation on days 1-40. Patients also undergo additional CT scan simulations without IV contrast over 20 minutes each on days 15 and 29.

Radiation Treatment is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Radiation Therapy for:

• Non-small cell lung cancer
• Breast cancer
• Prostate cancer
• Brain tumors
• Bone metastases

🇺🇸 Approved in United States as Radiation Therapy for:

• Non-small cell lung cancer
• Breast cancer
• Prostate cancer
• Brain tumors
• Bone metastases

🇨🇦 Approved in Canada as Radiation Therapy for:

• Non-small cell lung cancer
• Breast cancer
• Prostate cancer
• Brain tumors
• Bone metastases

🇯🇵 Approved in Japan as Radiation Therapy for:

• Non-small cell lung cancer
• Breast cancer
• Prostate cancer
• Brain tumors
• Bone metastases

🇨🇳 Approved in China as Radiation Therapy for:

• Non-small cell lung cancer
• Breast cancer
• Prostate cancer
• Brain tumors
• Bone metastases

🇨🇭 Approved in Switzerland as Radiation Therapy for:

• Non-small cell lung cancer
• Breast cancer
• Prostate cancer
• Brain tumors
• Bone metastases

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Rutgers Cancer Institute of New Jersey New Brunswick, NJ

RWJBarnabas Health - Robert Wood Johnson University Hospital New Brunswick, NJ

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Patients Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. [2021] Stereotactic ablative radiation therapy (SABR) is an emerging treatment option for patients with pulmonary metastases; identifying patients who would benefit from SABR can improve outcomes.

2. 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.

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

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013] Stereotactic ablative radiotherapy (SABR), otherwise known as stereotactic body radiation therapy (SBRT), is an external beam treatment modality that offers the ability to deliver with high precision large doses of radiation over a limited number of fractions. SABR is currently a standard of care in the treatment of early-stage primary non-small cell lung cancers (NSCLCs) that are medically inoperable and for metastases in many anatomical locations. To date, local control and toxicity parameters with SABR for early-stage NSCLCs are comparable to those found in reports of experiences with surgical resection. It is increasingly apparent that some patients with borderline resectable lung primaries are also looking to SABR as a noninvasive means of therapy. However, randomized comparisons have not been completed to assess survival in operable patients. This review summarizes the advanced technology and radiation concepts that have helped clinicians optimize the use of stereotactic ablative therapies for lung cancer, with an emphasis on the rationale for future continued use of this advanced treatment modality.

4. Australia pubmed.ncbi.nlm.nih.gov

Collaborative implementation of stereotactic ablative body radiotherapy: A model for the safe implementation of complex radiotherapy techniques in Australia. [2020] Stereotactic ablative radiotherapy (SABR) for lung cancer is a modality of treatment that has improved outcomes for lung cancer patients. However, radiotherapy for lung cancer is underutilized and fewer than half of elderly patients with non-small cell lung cancer (NSCLC) receive active treatment. The purpose of this study is to report on a collaboration in implementing an NSCLC SABR (stereotactic ablative body radiation) program safely, efficiently, and uniformly across several centers, including regional sites. The first aim of this paper is to detail the collaboration and implementation that started in 2013 and is ongoing. The second aim of this paper is to document early toxicities and quality of life outcomes.

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

Stereotactic ablative radiation therapy in lung cancer: an emerging standard. [2019] Significant advances have been made in the field of stereotactic ablative radiotherapy (SABR) for the treatment of pulmonary neoplasms in recent years. This review aims to summarize recent salient evidence on SABR for early-stage nonsmall cell lung cancer (ES-NSCLC).

6. Israel pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiation for Stage I Lung Cancer in Israel: A Retrospective Single-Center Report. [2022] Stereotactic ablative radiation therapy (SABR) is the application of a very high radiation dose to a small treatment volume. It is the new standard of care in medically inoperable early-stage lung cancer.

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

Colorectal Histology Is Associated With an Increased Risk of Local Failure in Lung Metastases Treated With Stereotactic Ablative Radiation Therapy. [2022] Stereotactic ablative radiation therapy (SABR) is increasingly used to treat lung oligometastases. We set out to determine the safety and efficacy of this approach and to identify factors associated with outcomes.

8. 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.

9. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. [2022] Stereotactic ablative body radiotherapy (SBRT, SABR) is being increasingly applied because of its high local efficacy, e.g., for small lung tumors. However, the optimum dosage is still under discussion. Here, we report data on 45 lung lesions [non-small cell lung cancer (NSCLC) or metastases] in 39 patients treated between 2009 and 2010 by SABR.

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

Lung Stereotactic Body Radiation Therapy. [2018] Lung stereotactic body radiation therapy (SBRT) is a novel and effective modality for treatment of early stage non-sail cell lung cancer (NSCLC), with expanding indications in locally advanced and metastatic disease. Herein, we will review current treatment recommendations for early stage NSCLC, detail treatment planning of SBRT, and discuss future directions.