Accelerated Radiation Therapy for Lung Cancer

Overseen By Mimi Le-Budka

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Stanford University

Disqualifiers: Pulmonary fibrosis, Previous thorax radiation, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of using radiation therapy to treat advanced lung cancer. It focuses on hypofractionated accelerated radiation therapy, which involves delivering higher doses of radiation over fewer sessions. The goal is to determine if this approach is effective without causing excessive harm to nearby organs. Individuals with lung cancer who are scheduled for radiation and other treatments may be suitable candidates, particularly if they have not previously received significant radiation to the chest. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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 coordinators or your doctor.

What prior data suggests that hypofractionated accelerated radiation therapy is safe for treating lung cancer?

Research has shown that hypofractionated accelerated radiation therapy (HART) for lung cancer is generally safe. Patients who received this treatment experienced lower radiation exposure to key organs such as the lungs, heart, and esophagus, reducing the risk of damage to these critical areas.

Other studies have found that HART is a safe option for those unable to undergo standard treatments. It effectively treats advanced lung cancer. Although no treatment is without risks, these findings suggest that many patients tolerate HART well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard lung cancer treatments that typically involve multiple weeks of radiation therapy, hypofractionated accelerated radiation therapy (HART) offers a unique approach by delivering higher doses over fewer sessions. This method can potentially reduce the overall treatment time from several weeks to just a few, which is a significant advantage for patients. Researchers are excited about HART because it may not only improve patient convenience but also maintain or even enhance the effectiveness of the treatment by targeting the cancer more aggressively while sparing healthy tissues.

What evidence suggests that hypofractionated accelerated radiation therapy might be an effective treatment for lung cancer?

Research has shown that hypofractionated accelerated radiation therapy (HART), which participants in this trial will receive, could be a promising treatment for advanced lung cancer. Unlike traditional radiation, HART uses higher doses in fewer sessions, potentially increasing treatment effectiveness. Studies have found that patients receiving HART experienced lower doses to vital organs like the lungs, heart, and esophagus, helping to reduce side effects. Additionally, patients treated with similar methods had an average survival time of about 13.6 months, with survival rates of 77.2% at one year, 50.9% at two years, and 32.1% at three years. This suggests that HART could effectively manage lung cancer while reducing risks to other organs. ^{2 3 4 6 7}

Who Is on the Research Team?

Lucas Vitzthum, MD, MAS

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with lung cancer who are fit enough to give consent and undergo treatment. They should expect to live at least 12 weeks, have a certain level of physical fitness (ECOG 0-2), and be ready for radiation therapy alongside other treatments.

Inclusion Criteria

I am able to care for myself and perform daily activities.

I am older than 18 years.

My lung cancer is confirmed by tests and I am set for specific radiation and concurrent therapy.

Exclusion Criteria

I cannot undergo radiation or systemic therapy as advised by my doctors.

I am under 18 years old.

I have been diagnosed with interstitial pulmonary fibrosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hypofractionated accelerated radiation therapy (HART) for lung cancer, with doses of 60-66 Gy in 30, 25, or 20 fractions

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of acute and late toxicities, progression-free survival, overall survival, and local control

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated accelerated radiation therapy

Trial Overview The study tests hypofractionated accelerated radiation therapy (HART) on patients with advanced lung cancer. It aims to see how well this intense, targeted radiation works when the tumor's size and location vary.

How Is the Trial Designed?

Group I: Hypofractionated accelerated radiation therapy (HART) Experimental Treatment 1 Intervention

Patients will either be treated with 60-66 Gy in 30, 25, or 20 fractions based on ability to meet constraints to key organs at risk

Hypofractionated accelerated radiation therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hypofractionated Radiotherapy for:

• Locally advanced non-small cell lung cancer (LA-NSCLC)
• Early-stage lung cancer
• Breast cancer

Approved in European Union as Hypofractionated Radiotherapy for:

• Locally advanced non-small cell lung cancer (LA-NSCLC)
• Early-stage lung cancer
• Breast cancer

Approved in Canada as Hypofractionated Radiotherapy for:

• Locally advanced non-small cell lung cancer (LA-NSCLC)
• Early-stage lung cancer
• Breast cancer

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

LUNGevity Foundation

Collaborator

Trials

8

Recruited

1,600+

Published Research Related to This Trial

In a study of 53 NSCLC patients treated with hypofractionated accelerated radiation therapy (HART) and concurrent chemotherapy, the treatment resulted in lower doses to critical organs like the lung, heart, and esophagus compared to standard fractionated radiation therapy (SFRT).

HART showed promising outcomes with lower rates of severe side effects, such as pneumonitis and esophagitis, and a trend towards reduced in-field recurrence, suggesting it can be a safe and effective option for select patients with favorable dosimetry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Selection and Outcomes for Hypofractionated Accelerated Radiation and Concurrent Chemotherapy for Non-Small-Cell Lung Cancer. Hui, C., Marquez, C., Lau, B., et al.[2023]

In a study of 148 patients with local-regionally recurrent breast cancer, hyperfractionated accelerated radiotherapy (HART) was well tolerated but did not show superior local-regional control rates compared to standard daily fractionation regimens, with 5-year local-regional control rates of 68%.

The study found that factors such as clinically evident residual disease and a short interval from mastectomy to recurrence significantly affected local-regional control, suggesting that alternative treatment strategies may be necessary to improve outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local-regional control of recurrent breast carcinoma after mastectomy: does hyperfractionated accelerated radiotherapy improve local control? Ballo, MT., Strom, EA., Prost, H., et al.[2019]

In a clinical trial involving 69 patients with non-small cell lung cancer (NSCLC), hyperfractionated accelerated radiation therapy (HART) demonstrated significantly better survival rates and local control compared to conventional fractionated irradiation (CFI), with 1-, 2-, and 3-year survival rates of 72%, 47%, and 28% for HART versus 60%, 18%, and 6% for CFI.

While HART was associated with a higher incidence of acute esophagitis (87% of patients), it did not lead to other severe complications, indicating that HART can be tolerated by most patients and may offer a more effective treatment option for NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperfractionated accelerated radiation therapy for non-small cell lung cancer: clinical phase I/II trial. Fu, XL., Jiang, GL., Wang, LJ., et al.[2019]

The hyperfractionated and accelerated radiotherapy (HART) protocol demonstrated a median survival of 16.8 months in 23 patients with inoperable non-small cell lung carcinoma (NSCLC), with 1-, 2-, and 3-year survival rates of 61%, 39%, and 19%, respectively.

The treatment was well-tolerated, with minimal toxicity reported; only a few patients experienced significant side effects, and there were no treatment-related deaths, suggesting that HART is a feasible option for patients ineligible for more aggressive therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperfractionated accelerated radiotherapy (HART) for inoperable, nonmetastatic non-small cell lung carcinoma of the lung (NSCLC): results of a phase II study for patients ineligible for combination radiochemotherapy. Koutaïssoff, S., Wellmann, D., Coucke, P., et al.[2019]

Hypofractionated accelerated radiotherapy (HART) for localized prostate cancer, involving 158 patients treated between 2011-2014, demonstrated low early toxicity rates, with 46% of patients experiencing grade 0 genitourinary toxicity and 75% experiencing grade 0 gastrointestinal toxicity.

The study suggests that using a precise dose delivery technique with image guidance and adjusting the number of treatment fractions based on risk levels is safe, but further long-term follow-up is necessary to evaluate late toxicity and effectiveness in tumor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early toxicity of hypofractionated radiotherapy for prostate cancer. Krupa, P., Ticha, H., Kazda, T., et al.[2022]

In a study of 111 non-small cell lung cancer (NSCLC) patients treated with accelerated hypofractionated radiotherapy (60 Gy in 15 fractions), the treatment showed favorable outcomes, with a median overall survival of 38.1 months for patients with no nodal involvement (N0) compared to 31.7 months for those with nodal involvement (N+).

The treatment was well tolerated, with a low incidence of severe toxicities (10.3% grade 3 toxicity) and no treatment-related deaths or hospitalizations, indicating its safety for patients who are not eligible for other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Hypofractionated Radiotherapy for Centrally Located Lung Tumours Not Suitable for Stereotactic Body Radiotherapy or Chemoradiotherapy. Zeng, KL., Poon, I., Ung, Y., et al.[2023]

Hyperfractionated accelerated radiation therapy (HART) for stage IIIA or IIIB non-small-cell lung cancer (NSCLC) was found to be practical and well tolerated, with 93% of the 30 enrolled patients completing the treatment.

The treatment resulted in a 54% overall objective response rate and a median survival of 13 months, indicating its efficacy is comparable to modern combined treatment regimens, with manageable toxicity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of hyperfractionated accelerated radiation therapy for nonresectable non-small-cell lung cancer: results of Eastern Cooperative Oncology Group 4593. Mehta, MP., Tannehill, SP., Adak, S., et al.[2018]

Hypofractionated radiation therapy (HypoRT) was found to be effective in treating inoperable advanced non-small cell lung cancer (NSCLC), with an overall response rate of 83% among 30 patients, and a median follow-up of 13 months.

The treatment was well-tolerated, with manageable acute toxicities; however, 37% of patients experienced locoregional recurrence, and 57% developed distant metastasis, indicating the need for further studies to compare HypoRT with conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image guided hypofractionated 3-dimensional radiation therapy in patients with inoperable advanced stage non-small cell lung cancer. Osti, MF., Agolli, L., Valeriani, M., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39349294/

Accelerated Hypofractionated Radiotherapy for Locally ... Accelerated hypofractionated radiotherapy has gained increasing interest for locally advanced NSCLC, as it can potentially increase radiobiologically effective ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525730423002437

Patient Selection and Outcomes for Hypofractionated ... Patients who underwent hypofractionated radiation therapy had statistically significant lower dose to the lungs, heart, and esophagus, highlighting the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02720614

Study Details | NCT02720614 | Hypofractionated Radiation ... Compared with conventional fractionated radiotherapy, accelerated hypofractionated radiotherapy can yield higher BED, shorten the total treatment time, and ...

4. jto.org jto.org/article/S1556-0864(24)02353-0/fulltext

Accelerated Hypofractionated Radiotherapy for Locally ... Accelerated hypofractionated radiotherapy has gained increasing interest for locally advanced NSCLC, as it can potentially increase ...

5. redjournal.org redjournal.org/article/S0360-3016(24)02650-6/fulltext

Accelerated Hypofractionated Radiotherapy for the ... The median OS for hypo-RT alone (reported by 10 studies) was 13.6 months (6-46), while the 1-, 2-, and 3-year OS was 77.2% (38-98), 50.9% (38-85), and 32.1% (29 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11724749/

Accelerated Hypofractionated Radiotherapy for Locally ... Accelerated hypofractionated radiotherapy has gained increasing interest for locally advanced NSCLC, as it can potentially increase radiobiologically effective ...

7. e-roj.org e-roj.org/journal/view.php?number=1595

Part 2. Lung (non-small cell lung cancer) HFRT has demonstrated promising results, and the reviewed data support its feasibility and comparable efficacy for the treatment of locally advanced NSCLC.