Proton Beam Radiation Therapy for Non-Small Cell Lung Cancer

Overseen By Aparna H. Kesarwala, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Must not be taking: Investigational agents

Disqualifiers: Stage IV disease, Small cell lung cancer, EGFR/ALK alterations, 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 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests proton beam radiation therapy for individuals with non-small cell lung cancer. The researchers aim to determine if proton therapy, which targets cancer cells while sparing healthy tissues, is more effective than standard radiation post-surgery. It specifically targets those who have undergone surgery and whose cancer has spread to certain lymph nodes in the chest. Suitable participants have completed surgery and chemotherapy and do not have complicating conditions such as stage IV cancer or previous thoracic radiation. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients should not have had systemic therapy less than 2 weeks before starting radiotherapy, which might imply a need to pause certain treatments. It's best to discuss your specific medications with the trial team.

What prior data suggests that proton beam radiation therapy is safe for non-small cell lung cancer patients?

Research shows that proton beam radiation therapy can safely treat non-small cell lung cancer. Studies have found that patients generally tolerate this therapy well. It uses a precise form of radiation that targets cancer cells while sparing healthy tissue, reducing the risk of harmful side effects compared to traditional radiation treatments.

In real-world studies, patients with various stages of lung cancer have received proton beam therapy with few serious side effects. The treatment's ability to focus on the tumor helps protect nearby organs and tissues, addressing a common concern with other types of radiation therapy. Overall, evidence suggests that proton beam therapy is a promising and safe option for patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Proton beam radiation therapy is unique because it uses a precise form of radiation that targets tumors more accurately than traditional radiation treatments. Unlike standard options like X-ray radiation, proton therapy delivers high doses of radiation directly to the tumor with minimal damage to surrounding healthy tissues. This precision reduces side effects and potentially improves outcomes for patients with non-small cell lung cancer. Researchers are excited about its potential to offer more effective treatment with fewer complications.

What evidence suggests that proton beam radiation therapy might be an effective treatment for non-small cell lung cancer?

Research has shown that proton beam radiation therapy, which participants in this trial will receive, holds promise for treating non-small cell lung cancer. This therapy targets cancer cells more precisely, potentially leading to fewer side effects than traditional radiation. Studies have found that proton therapy can be safe and effective for early-stage non-small cell lung cancer, offering similar survival rates to other treatments with fewer negative effects. Although proton therapy costs more, it is considered a promising option because it better protects healthy tissue. Initial findings suggest that using proton therapy after surgery might help reduce the risk of cancer returning by focusing on affected areas while protecting nearby healthy tissue. ^{1 2 4 6 7}

Who Is on the Research Team?

William Stokes

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-small cell lung cancer who've had surgery to remove the tumor and affected lymph nodes. They should be in decent health, have a life expectancy of more than 12 weeks, and not be pregnant or planning to become so during the trial. Participants must agree to use contraception and have finished any previous cancer treatments at least two weeks before starting.

Inclusion Criteria

I am willing and able to follow the study's schedule and procedures.

I had surgery to remove lung cancer completely, including part of the lung and lymph nodes.

My white blood cell count is at least 2000/uL without recent medical help.

Exclusion Criteria

My tumor has specific changes in the EGFR or ALK genes.

I have had radiation therapy to the chest area before.

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment Planning

Patients undergo radiation treatment planning

1 week

Proton Beam Radiation Therapy

Patients undergo proton beam radiation therapy and collection of blood samples

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Proton Beam Radiation Therapy

Trial Overview The study is testing proton beam radiation therapy as a post-surgery treatment for lung cancer patients. Proton therapy targets cancer cells while sparing healthy tissue, potentially reducing recurrence risk compared to conventional radiation.

How Is the Trial Designed?

Group I: Treatment (proton beam radiation therapy) Experimental Treatment 3 Interventions

Patients undergo radiation treatment planning and then undergo proton beam radiation therapy on study. Patients also undergo collection of blood samples.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 51 patients with advanced inoperable non-small cell lung cancer (NSCLC), treatment with intensity-modulated proton therapy (IMPT) combined with chemotherapy resulted in a median overall survival of 33.9 months and a disease-free survival of 12.6 months, indicating effective disease control.

The treatment was well tolerated, with an 18% rate of grade 3 toxicities, primarily esophagitis and dermatitis, and no severe (grade 4 or 5) toxicities reported, suggesting a favorable safety profile for this combined therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes after intensity-modulated proton therapy with concurrent chemotherapy for inoperable non-small cell lung cancer. Elhammali, A., Blanchard, P., Yoder, A., et al.[2020]

Proton beam therapy for lung cancer significantly reduces the average dose of radiation to the lungs (Dmean) and the volume of lung receiving higher doses (V20, V10, V5) compared to both three-dimensional conformal photon radiotherapy (3D-CRT) and intensity-modulated photon radiotherapy (IMRT), based on an analysis of six clinical trials.

While proton therapy does not lower the average dose to the esophagus, it does reduce the dose to the heart, suggesting a safer profile for patients undergoing lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dosimetric comparing between protons beam and photons beam for lung cancer radiotherapy: a meta-analysis]. Tian, G., Li, N., Li, G.[2021]

High-dose proton beam therapy (PBT) for Stage I non-small-cell lung cancer (NSCLC) showed promising efficacy, with 2-year local progression-free and overall survival rates of 80% and 84%, respectively, based on a study of 37 patients treated between 1999 and 2003.

While PBT was generally safe with no serious acute toxicities, late pulmonary toxicities were observed in 6 patients, indicating a need for further investigation, especially for those with Stage IB disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose proton beam therapy for Stage I non-small-cell lung cancer. Nihei, K., Ogino, T., Ishikura, S., et al.[2018]

Proton-beam therapy is an effective treatment option for non-small-cell lung cancer (NSCLC), especially for patients who cannot undergo surgery due to advanced disease or other medical conditions.

This type of radiotherapy allows for precise targeting of tumors, delivering high doses to the cancer while sparing surrounding healthy tissues, making it a promising alternative for lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of proton-beam therapy in the treatment of non-small-cell lung cancer. Oshiro, Y., Sakurai, H.[2013]

In a study of 99 patients with locally advanced nonsmall cell lung cancer treated with proton beam therapy (PBT), 21% experienced grade 2 or higher radiation pneumonitis, indicating a notable risk of this complication.

The existing photon-based QUANTEC models for predicting radiation pneumonitis were found to be applicable to PBT with only minor adjustments needed, suggesting that these models can help tailor treatment plans for patients undergoing PBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updating Photon-Based Normal Tissue Complication Probability Models for Pneumonitis in Patients With Lung Cancer Treated With Proton Beam Therapy. Jain, V., Niezink, AGH., Frick, M., et al.[2021]

In a study of 195 patients with locally advanced non-small cell lung cancer (LA-NSCLC) treated with proton beam therapy (PBT), the treatment showed low rates of severe side effects, with only a few grade 3 adverse events reported and no grade 4 events, indicating a favorable safety profile.

The median overall survival (OS) for patients was 19.0 months, and factors such as good performance status, the use of pencil beam scanning, and higher doses of radiation were associated with improved survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes After Proton Beam Therapy for Locally Advanced Non-Small Cell Lung Cancer: Analysis of a Multi-institutional Prospective Registry. Jongen, A., Charlier, F., Baker, K., et al.[2022]

Proton therapy is a promising treatment option for lung cancer, particularly for patients with non-small cell lung cancer (NSCLC), as it can deliver higher radiation doses to tumors while minimizing exposure to surrounding healthy tissues, potentially reducing treatment-related toxicities.

This therapy not only allows for safer reirradiation but also facilitates the combination of radiation therapy with chemotherapy and surgery, enhancing treatment options for patients with early-stage and locally advanced NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of proton therapy in the treatment of lung cancers. Simone, CB., Rengan, R.[2022]

Proton therapy for non-small-cell lung cancer generally maintains effective dose delivery, with only a slight maximum decrease in target coverage (1.4%) for most patients, indicating its safety and efficacy compared to traditional photon therapy.

However, for small tumors located deep within lung tissue, there can be significant underdosing (up to 26%), highlighting the need for further research to address this issue and improve treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analytical modeling of depth-dose degradation in heterogeneous lung tissue for intensity-modulated proton therapy planning. Winter, J., Ellerbrock, M., Jäkel, O., et al.[2022]

In a study of 64 patients with unresectable stage III non-small cell lung cancer (NSCLC), concurrent chemotherapy and proton beam radiotherapy (PBT) resulted in a median overall survival of 26.5 months and a 5-year overall survival rate of 29%, indicating promising efficacy for this treatment approach.

The treatment was associated with relatively low rates of severe toxic effects, with no grade 5 toxicities reported, suggesting that PBT may reduce the harmful side effects compared to traditional photon therapy, although further optimization of the technique is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Beam Radiotherapy and Concurrent Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer: Final Results of a Phase 2 Study. Chang, JY., Verma, V., Li, M., et al.[2022]

Proton beam therapy (PBT) offers a promising approach to lung cancer treatment by potentially reducing radiation toxicity due to its unique Bragg peak, which allows for more targeted delivery of radiation.

Current data suggests that PBT is effective for early-stage and locally-advanced non-small cell lung cancer (NSCLC), although there are technical challenges such as managing anatomical changes and patient movement during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Beam Therapy for Non-Small Cell Lung Cancer: Current Clinical Evidence and Future Directions. Berman, AT., James, SS., Rengan, R.[2022]

Proton stereotactic body radiation therapy (SBRT) was found to be effective and well tolerated in 15 patients with medically inoperable stage I non-small-cell lung cancer (NSCLC), achieving a 2-year overall survival rate of 64% and a local control rate of 100%.

The treatment was associated with minimal toxicity, with only one case of grade 3 pneumonitis and a few instances of grade 2 side effects, indicating that proton SBRT may be a safe option for patients with significant pulmonary comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton SBRT for medically inoperable stage I NSCLC. Westover, KD., Seco, J., Adams, JA., et al.[2021]

Proton radiotherapy for non-small-cell lung cancer (NSCLC) showed a 5-year overall survival rate of 29%, with significantly better outcomes for early-stage patients, particularly a 70% survival rate for Stage IA patients.

The treatment was found to be very safe, with 92% of patients experiencing only mild acute lung toxicity (Grade 1 or less), and minimal late toxicity, indicating a favorable safety profile for proton therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of proton radiotherapy for non-small-cell lung cancer. Shioyama, Y., Tokuuye, K., Okumura, T., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4586764/

Proton Beam Therapy for Non-Small Cell Lung Cancer Proton beam therapy, through its characteristic Bragg peak, has the potential to decrease the toxicity of radiotherapy, and, subsequently improve patient ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8767257/

Clinical Outcomes After Proton Beam Therapy for Locally ... PBT appears to yield low rates of adverse events with an OS similar to other retrospective studies on PBT for LA-NSCLC.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016781402500163X

Clinical outcomes of proton beam therapy for inoperable ... A meta-analysis revealed that PBT did not improve overall survival (OS) and progression-free survival (PFS) compared to SBRT, and the rate of serious adverse ...

4. tlcr.amegroups.org tlcr.amegroups.org/article/view/30688/html

Proton therapy for non-small cell lung cancer: the road ahead High-dose hypofractionated proton beam radiation therapy is safe and effective for central and peripheral early-stage non-small cell lung cancer: results of ...

5. thegreenjournal.com thegreenjournal.com/article/S0167-8140(22)04550-9/fulltext

Cost-effectiveness of proton radiotherapy versus photon ... Proton radiotherapy (PT) is a promising but more expensive strategy than photon radiotherapy (XRT) for the treatment of non-small cell lung cancer (NSCLC).

6. advancesradonc.org advancesradonc.org/article/S2452-1094(21)00125-1/fulltext

Clinical Outcomes After Proton Beam Therapy for Locally ... Herein, we report clinical outcomes of patients treated with PBT for locally advanced non-small cell lung cancer (LA-NSCLC). Methods and ...

7. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)00163-X/abstract

Clinical outcomes of proton beam therapy for inoperable ... This study provided real-world treatment outcomes of PBT for inoperable stage I-IIA NSCLC in Japan. Keywords. Proton beam therapy · Early stage · Non-small cell ...