Adaptive Radiation Therapy for Non-Small Cell Lung Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

34 Participants Needed

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

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

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

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Stereotactic ablative radiation therapy (SABR) was found to be effective for treating pulmonary metastases, with a median follow-up of 23 months showing improved overall survival (OS) for patients with 3 or fewer metastases compared to those with more (74.2% vs. 59.3% at 24 months).

Patients with less responsive primary tumors (like adrenal or pancreatic cancers) had higher local failure rates, suggesting that higher doses of SABR or surgical options may be necessary for these cases to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. Pasalic, D., Lu, Y., Betancourt-Cuellar, SL., et al.[2021]

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) is an effective treatment for early-stage non-small cell lung cancers (NSCLCs) that are medically inoperable, providing local control and toxicity levels comparable to surgical resection.

SABR is gaining interest as a noninvasive treatment option for patients with borderline resectable lung cancers, although further randomized studies are needed to evaluate its survival benefits in operable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. Iyengar, P., Westover, K., Timmerman, RD.[2013]

A collaborative program for implementing stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer (NSCLC) across multiple centers in New South Wales has been successfully established, demonstrating a safe and efficient approach to treatment.

In a study involving 41 patients, the early toxicity profile of SABR was consistent with existing literature, and there was no significant impact on quality of life, indicating that SABR can be a viable treatment option for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative implementation of stereotactic ablative body radiotherapy: A model for the safe implementation of complex radiotherapy techniques in Australia. Hau, E., Hegi-Johnson, F., Atkinson, C., et al.[2020]

Stereotactic ablative radiotherapy (SABR) is the standard treatment for medically inoperable early-stage non-small cell lung cancer (ES-NSCLC) and has shown benefits over lower-dose radiotherapy regimens.

While SABR is generally safe and cost-effective, it can lead to increased toxicity in patients with tumors near the tracheobronchial tree or those with interstitial lung disease, highlighting the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy in lung cancer: an emerging standard. Mutsaers, A., Chen, H., Louie, AV.[2019]

Stereotactic ablative radiation therapy (SABR) for stage I lung cancer at Sheba Medical Center showed a median overall survival of 46 months and a 3-year survival rate of 59%, indicating its efficacy as a treatment for inoperable patients.

The treatment demonstrated excellent local control at 88% and had manageable toxicity, with only 8.4% of patients experiencing chest wall pain and a low incidence of severe side effects, suggesting it is a safe option for patients with early-stage lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiation for Stage I Lung Cancer in Israel: A Retrospective Single-Center Report. Appel, S., Lawrence, YR., Goldstein, J., et al.[2022]

Stereotactic ablative radiation therapy (SABR) for lung oligometastases shows promising safety and efficacy, with a 24-month overall survival rate of 74.6% and minimal toxicity, as only one significant adverse event was reported among 77 patients studied over an average follow-up of 22 months.

Colorectal metastases exhibited a notably higher local failure rate compared to other types of tumors, suggesting they may be more resistant to SABR, indicating a need for potential dose escalation strategies for these patients.

NCBI (Pubmed)

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. Binkley, MS., Trakul, N., Jacobs, LR., et al.[2022]

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]

In a study of 39 patients with 45 lung lesions treated with stereotactic ablative body radiotherapy (SBRT), local progression-free survival rates were high, with 90.5% at 1 year and 80.5% at 2 years, indicating effective tumor control.

The treatment was well-tolerated with only mild acute side effects, suggesting that the moderate dose schedules of 35 Gy (5 fractions) or 37.5 Gy (3 fractions) are safe and effective for managing non-small cell lung cancer and metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. Duncker-Rohr, V., Nestle, U., Momm, F., et al.[2022]

Lung stereotactic body radiation therapy (SBRT) is an effective treatment option for early-stage non-small cell lung cancer (NSCLC) and is increasingly being used for more advanced cases.

The review highlights current treatment recommendations and planning for SBRT, indicating its growing role in managing lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Stereotactic Body Radiation Therapy. Rehman, S., Roach, MC., Bradley, JD., et al.[2018]

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]

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]

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

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]

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]

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

Stereotactic ablative radiation therapy in lung cancer: an emerging standard. [2019]

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

Stereotactic Ablative Body Radiation for Stage I Lung Cancer in Israel: A Retrospective Single-Center Report. [2022]

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]

8. England pubmed.ncbi.nlm.nih.gov

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

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

Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. [2022]

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

Lung Stereotactic Body Radiation Therapy. [2018]