Image-Guided Radiation Therapy for Lung Cancer

Overseen By Zhongxing Liao

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Prior radiotherapy, T4 tumor, pregnancy, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods of delivering radiation therapy for stage II-IIIB non-small cell lung cancer. It compares photon beam and proton beam radiation, both designed to deliver a higher dose directly to the tumor while minimizing harm to surrounding healthy tissue. Participants will join one of two groups to determine which method is more effective and has fewer side effects. This trial may suit individuals with non-small cell lung cancer who have not received certain types of radiation therapy and can safely undergo concurrent chemoradiation therapy. As a Phase 1, Phase 2 trial, it focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage research.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this image-guided radiation therapy is safe for lung cancer patients?

Research has shown that image-guided intensity-modulated radiation therapy (IMRT) is generally manageable for patients. Studies indicate it can better control tumors and cause fewer side effects than older methods. For instance, one study found that lung cancer patients experienced fewer complications with this technique due to its precise targeting of tumors.

Regarding image-guided intensity-modulated proton therapy (IMPT), research also shows promising results. One review linked proton therapy to good tumor control with fewer side effects. Another study found that patients with early-stage lung cancer experienced minimal harmful effects with this approach.

Both treatments aim to target tumors more accurately, protecting healthy tissue and potentially leading to fewer side effects. While these treatments are still under evaluation, current findings suggest they are relatively safe for lung cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about image-guided radiation therapy for lung cancer because it offers more precise targeting of tumors compared to traditional methods. Unlike conventional radiation therapy, which can sometimes affect healthy tissues, image-guided intensity-modulated radiation therapy (IMRT) and image-guided intensity-modulated proton therapy (IMPT) use advanced imaging techniques to adjust the radiation beams in real-time, minimizing damage to surrounding healthy cells. This precision could lead to fewer side effects and potentially better outcomes for patients. Additionally, IMPT uses proton beams, which have a unique ability to release their energy directly at the tumor site, sparing more of the healthy tissue, which is particularly promising for improving patient quality of life during and after treatment.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

This trial will compare different advanced radiation techniques for treating non-small cell lung cancer. Research has shown that image-guided radiotherapy (IGRT), which participants in this trial may receive, can make radiation treatment more precise, improving tumor control and reducing complications. One arm of this trial will use Intensity-Modulated Radiation Therapy (IMRT), which has been successfully used to treat lung cancer, with evidence suggesting it can lead to better long-term results. Another arm will study Proton Beam Therapy, which has shown promising results in controlling tumors with fewer side effects. Both advanced radiation techniques aim to target the tumor more accurately, minimizing harm to nearby healthy tissue. Overall, these methods are designed to deliver a higher dose of radiation directly to the tumor, potentially improving treatment effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Zhongxing Liao

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with stage II-IIIB non-small cell lung cancer that hasn't been removed by surgery or has come back after surgery or SBRT. They must be able to handle chemo, have a KPS score of at least 70, stable weight, and good blood counts and organ function. Pregnant individuals or those who can't use contraception are excluded.

Inclusion Criteria

My doctor thinks I can handle both chemotherapy and radiation at the same time.

Your liver enzymes (ALT and AST) are not more than 2.5 times the normal level, or not more than 5 times the normal level if you have liver involvement.

I am able to care for myself but may not be able to do active work.

Exclusion Criteria

I have not had radiation that could affect my heart, spine, or esophagus.

I have chosen not to participate in this trial.

My cancer has spread to my esophagus, spinal cord, major blood vessels, or heart.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo image-guided IMRT or IMPT with SIB once daily 5 days a week for up to 6 weeks

6 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Every 3-4 months for 3 years, every 6 months for 2 years, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Image Guided Radiation Therapy
• Intensity-Modulated Radiation Therapy
• Photon Beam Radiation Therapy
• Proton Beam Radiation Therapy

Trial Overview The study compares two advanced radiation therapies: intensity-modulated photon beam therapy (using X-rays) and proton beam therapy (using protons). It aims to deliver higher doses directly to the tumor while protecting healthy tissue. Participants will also undergo motion management during treatment.

How Is the Trial Designed?

Group I: Arm II (image-guided IMPT) Experimental Treatment 5 Interventions

Patients undergo image-guided IMPT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (image-guided IMRT) Experimental Treatment 5 Interventions

Patients undergo image-guided IMRT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

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

Approved in United States as Image Guided Radiation Therapy for:

• Various cancers including but not limited to prostate, lung, breast, head and neck cancers

Approved in European Union as Image Guided Radiation Therapy for:

• Various cancers including but not limited to prostate, lung, breast, head and neck cancers

Approved in Canada as Image Guided Radiation Therapy for:

• Various cancers including but not limited to prostate, lung, breast, head and neck cancers

Approved in Japan as Image Guided Radiation Therapy for:

• Various cancers including but not limited to prostate, lung, breast, head and neck cancers

Approved in China as Image Guided Radiation Therapy for:

• Various cancers including but not limited to prostate, lung, breast, head and neck cancers

Approved in Switzerland as Image Guided Radiation Therapy for:

• Various cancers including but not limited to prostate, lung, breast, head and neck cancers

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Different imaging techniques used in lung cancer treatments result in varying radiation doses to patients, with planar and stereoscopic imaging delivering low doses around 1 mGy, while volumetric imaging can range from 10-50 mGy.

Fluoroscopy poses the highest risk, with doses reaching up to 150 mGy, but optimizing imaging protocols can significantly reduce overall patient exposure during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging dose assessment for IGRT in particle beam therapy. Steiner, E., Stock, M., Kostresevic, B., et al.[2018]

In a study of 22 patients with locally advanced rectal cancer, image-guided radiotherapy (IGRT) led to complete surgical resection in all cases, with 32% of patients showing no residual tumor after treatment.

The treatment was associated with minimal toxicity, although one patient experienced severe side effects likely due to an overdose of capecitabine, suggesting that IGRT is a promising approach for reducing complications in rectal cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of image-guided radiotherapy for locally advanced rectal cancer. Nguyen, NP., Ceizyk, M., Almeida, F., et al.[2011]

Recent advancements in radiotherapy, such as conformal 3D radiotherapy and IMRT, have improved the precision of targeting tumors while minimizing damage to surrounding healthy tissues, thanks to better imaging techniques.

The development of image-guided radiotherapy (IGRT) and adaptive radiotherapy (ART) allows for real-time adjustments during treatment, enhancing the accuracy of tumor targeting and improving outcomes for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Present and future of the image guided radiotherapy (IGRT) and its applications in lung cancer treatment]. Lefkopoulos, D., Ferreira, I., Isambert, A., et al.[2007]

In a study of 55 patients with stage I non-small cell lung cancer (NSCLC), image-guided proton therapy (IGPT) demonstrated high efficacy with a 3-year overall survival rate of 87% and local control rate of 96%.

The treatment was well tolerated, with only mild toxicities reported (grade 2), such as radiation pneumonitis in 9% of patients, and no severe (grade 3 or higher) toxicities observed, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of image-guided proton therapy for histologically confirmed stage I non-small cell lung cancer. Nakajima, K., Iwata, H., Ogino, H., et al.[2018]

Image guided radiation therapy (IGRT) is widely used in pediatric patients, with about 750 children treated annually across seven international institutions, showing high usage rates for various tumor types, especially central nervous system tumors (98%).

There is significant variability in IGRT practices and planning target volume (PTV) margins among institutions, highlighting the need for prospective studies to optimize IGRT protocols and minimize unnecessary radiation exposure in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice patterns of photon and proton pediatric image guided radiation treatment: results from an International Pediatric Research consortium. Alcorn, SR., Chen, MJ., Claude, L., et al.[2018]

The study involved 7 patients with pulmonary cancer, where image-guided radiotherapy (IGRT) using active breath control (ABC) and a stereotactic body frame was evaluated for its effectiveness in reducing positioning errors during treatment.

Results showed that while positioning errors were reduced after corrections, the differences were not statistically significant; however, the treatment led to a complete response in 8 tumor targets, indicating the potential efficacy of this approach in increasing radiation dose while minimizing treatment time and toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A preliminary study on image guided hypofractionated radiotherapy for pulmonary tumor]. Xu, F., Bai, S., Zhang, H., et al.[2010]

A survey of 1,089 radiation oncologists revealed that 93.5% currently use image-guided radiation therapy (IGRT), indicating its widespread adoption in clinical practice.

Most oncologists use IGRT infrequently, with 59.1% planning to increase its use in the future, suggesting a growing trend towards integrating these imaging technologies for better tumor localization and patient setup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of image-guided radiation therapy use in the United States. Simpson, DR., Lawson, JD., Nath, SK., et al.[2021]

Patients with high-risk prostate cancer treated with image-guided intensity-modulated radiotherapy (IG-IMRT) experienced significantly lower rates of gastrointestinal (GI) toxicity (5.8%) compared to those treated with 3D conformal radiotherapy (3DCRT) (57.3%), indicating that IG-IMRT is a safer option.

Both IG-IMRT and 3DCRT showed similar rates of biochemical progression-free survival at 3 years (90.3% for IG-IMRT vs. 86.0% for 3DCRT), suggesting that while IG-IMRT reduces toxicity, it does not compromise treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance. Sveistrup, J., af Rosenschöld, PM., Deasy, JO., et al.[2021]

In a study of 55 patients with inoperable non-small cell lung cancer (NSCLC) treated with intensity-modulated radiation therapy (IMRT), the 2-year local control rate was 50% for stage I/II patients and 58% for stage III patients, indicating effective disease management.

The treatment was associated with manageable toxicity, with only 11% of patients experiencing grade 3 acute pulmonary toxicity and no acute treatment-related deaths, suggesting that IMRT is a safe option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy (IMRT) for inoperable non-small cell lung cancer: the Memorial Sloan-Kettering Cancer Center (MSKCC) experience. Sura, S., Gupta, V., Yorke, E., et al.[2022]

In a study of 192 patients with localized prostate cancer, using prostate-based IGRT (P-IGRT) resulted in significantly lower acute gastrointestinal toxicities compared to bony structure-based IGRT (B-IGRT), with rates of 3% versus 11%.

Both P-IGRT and B-IGRT showed similar prostate-specific antigen failure-free survival rates at 3 years (95.5% for P-IGRT and 92.7% for B-IGRT), indicating that P-IGRT can reduce toxicity without compromising tumor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. Nakamura, K., Mizowaki, T., Inokuchi, H., et al.[2018]

Prostate cancer patients receiving image-guided radiotherapy (IGRT) experienced significantly less severe acute toxicity, such as urinary frequency, diarrhoea, and fatigue, compared to those who did not receive IGRT, with 23% vs 7% for urinary frequency ≥G3 and 15% vs 3% for diarrhoea ≥G2.

The onset of these toxicities was earlier in the non-IGRT group, indicating that IGRT not only reduces the severity of symptoms but also delays their onset, leading to a more tolerable treatment experience for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity in prostate cancer patients treated with and without image-guided radiotherapy. Gill, S., Thomas, J., Fox, C., et al.[2021]

Image-guided radiation therapy (IGRT) has evolved significantly and is now widely used in routine clinical practice, emphasizing the importance of quality and patient safety in its application across various treatment techniques and anatomical sites.

The American Society for Radiation Oncology recommends a comprehensive quality-assurance program and an interdisciplinary team approach to ensure IGRT is performed safely and effectively, highlighting the need for ongoing updates to practice guidelines as technology advances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4129522/

Proton beam therapy for locally advanced lung cancer: A review This review examines proton beam therapy (PBT) as a component of a combined modality program for locally advanced lung cancers.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01629498

NCT01629498 | Image-Guided, Intensity-Modulated ... This partially randomized phase I/II trial studies the side effects and best dose of image-guided, intensity-modulated photon or proton beam radiation therapy

3. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-018-1144-5

Clinical outcomes of image-guided proton therapy for ... Two prospective phase II trials were designed to assess the efficacy and safety of image-guided proton therapy (IGPT) for either medically inoperable or ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2331518023001592

Image-Guided Hypofractionated Proton Therapy in Early ... Image-guided hypofractionated PT for early-stage NSCLC provides promising local control and long-term survival with a low likelihood of toxicity.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7332209/

Image guidance in radiation therapy for better cure of cancer IGRT is the most convincing success story of radiation oncology over the last decades, and it remains a major driving force of innovation.

6. cancer.gov cancer.gov/news-events/cancer-currents-blog/2020/proton-therapy-safety-versus-traditional-radiation

Is Proton Therapy Safer than Traditional Radiation? - NCI A new observational study compared the safety and effectiveness of proton therapy and traditional radiation in adults with advanced cancer.

7. gravitas.acr.org gravitas.acr.org/PPTS/GetDocumentView?docId=175

ACR–ARS Practice Parameter for the Performance of Proton ... Ensuring proper orientation of volumetric patient image data on the radiation treatment planning (RTP) system. Designing and generating the treatment plan under ...