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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for planning radiation therapy to minimize side effects in people with advanced non-small cell lung cancer (NSCLC). Researchers are testing adaptive radiation planning, which adjusts the radiation plan at set intervals, to determine if it better protects healthy tissues during treatment. This trial is suitable for individuals with stage II-IV NSCLC undergoing chemoradiation and immunotherapy. Participants must have a confirmed diagnosis of locally advanced NSCLC and be eligible for radiation treatment. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future cancer treatments.

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 prior data suggests that adaptive radiation planning is safe for non-small cell lung cancer patients?

Research has shown that stereotactic body radiation therapy (SBRT) is a safe and effective treatment for early-stage non-small cell lung cancer (NSCLC). Studies indicate that SBRT delivers high doses of radiation directly to the tumor while protecting nearby healthy tissue, reducing side effects. One study on a similar method, SMART (Stereotactic MR-Guided Adaptive Radiation Therapy), found it safe even for tumors near vital organs. This suggests that adaptive radiation therapy, like the one under study, is generally well-tolerated by lung cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores adaptive radiation therapy for non-small cell lung cancer, a technique that tailors radiation doses to changes in tumor size and shape throughout treatment. Unlike traditional radiation therapy that follows a fixed plan, adaptive radiation can adjust to a tumor's response, potentially improving accuracy and sparing healthy tissue. This dynamic approach could lead to better outcomes and fewer side effects, offering a promising advancement over existing standard care options.

What evidence suggests that adaptive radiation planning is effective for reducing side effects in non-small cell lung cancer?

Research has shown that adaptive radiation therapy (ART) effectively treats non-small cell lung cancer (NSCLC) by precisely targeting the tumor. This method reduces radiation exposure to healthy tissue. Studies indicate that ART lowers side effects by adjusting treatment as the tumor changes size. In this trial, patients will receive supportive care, including CT simulation with or without a contrast agent, alongside standard-of-care chemoradiation. For patients with locally advanced NSCLC, combining ART with chemotherapy has improved results by protecting normal tissues. By continuously updating the radiation plan, ART aims to make treatment safer and more effective. ^{5 6 7 8 9}

Who Is on the Research Team?

Salma Jabbour, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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 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]

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]

Citations

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Adapt or Perish: Adaptive RT for NSCLC The primary goal of adaptive radiation therapy (ART) for lung cancer is reducing normal tissue irradiated, which requires careful consideration and study.

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Stereotactic body radiation therapy for stage I medically ... Stereotactic ablative body radiation therapy (SBRT) has emerged as the standard treatment for inoperable patients with stage I non-small cell lung cancer ( ...

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Adapt or Perish: Adaptive RT for NSCLC Daily adaptive versus non-adaptive external beam radiation therapy with concurrent chemotherapy for locally advanced non-small cell lung cancer (NSCLC)

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7. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425001939

Safety and Efficacy of Stereotactic MR-Guided Adaptive ... SMART with daily online adaptation achieved excellent local control and a favorable safety profile in ultracentral NSCLC, comparable to ...

8. por-journal.com por-journal.com/journals/pathology-and-oncology-research/articles/10.3389/pore.2024.1611709/full

Stereotactic body radiotherapy in lung cancer It is a radiation therapy technique with image guidance that can deliver very high radiation doses (ablative doses) to the target (tumor) with ...

9. ccts.amegroups.org ccts.amegroups.org/article/view/52566/html

Advances in stereotactic body radiation therapy for early stage ... Stereotactic body radiation therapy (SBRT) has emerged as an effective, non-invasive treatment option for patients with medically inoperable NSCLC.