Radiotherapy for Advanced Lung Cancer

(DRO2301 Trial)

Overseen By Therese Smudzin

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Rochester

Must not be taking: Chemotherapy

Disqualifiers: Prior thoracic radiation, Lupus, Sjogren's, 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 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, concurrent chemotherapy is not allowed, but concurrent immunotherapy is allowed.

What data supports the effectiveness of the treatment Prophylactic Palliative Radiotherapy, Prophylactic Radiation Therapy, Palliative Radiotherapy for advanced lung cancer?

Palliative radiotherapy is effective in relieving symptoms of advanced cancer, including lung cancer, and is a key part of managing symptoms in patients who cannot undergo aggressive treatments. It helps control local disease and symptoms, providing rapid relief and improving patient-focused outcomes. ^{1 2 3 4 5}

Is palliative radiotherapy safe for humans?

Palliative radiotherapy is generally safe for humans, causing mostly mild and local side effects without affecting the whole body. ^{5 6 7 8 9}

How is Prophylactic Palliative Radiotherapy different from other treatments for advanced lung cancer?

Prophylactic Palliative Radiotherapy is unique because it focuses on preventing symptoms and providing relief for advanced lung cancer patients, often using short courses of radiation to quickly alleviate symptoms with minimal side effects. Unlike some treatments that aim to cure, this approach prioritizes comfort and quality of life, and can be tailored with advanced techniques like 3D planning to improve outcomes. ^{1 5 10 11 12}

What is the purpose of this trial?

Patients with metastatic non small cell lung cancer with high risk location or size are treated with prophylactic radiation therapy in conjunction with standard of care systemic therapy.

Eligibility Criteria

This trial is for adults with Stage IV Non-Small Cell Lung Cancer without certain genetic mutations. They should have a large lung lesion or cancer near critical areas like the esophagus or heart, and not have had previous chest radiotherapy. It's not suitable for those who've received thoracic radiation before.

Inclusion Criteria

My condition involves the esophagus.

My condition involves the spine.

My lung or lymph node cancer can be treated with chest radiation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive prophylactic palliative radiotherapy in conjunction with standard of care systemic therapy

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Prophylactic Palliative Radiotherapy

Trial Overview The study tests if prophylactic palliative radiotherapy alongside standard treatments can prevent symptoms from worsening in patients with high-risk metastatic lung cancer lesions within the chest area.

Participant Groups

Group I: Prophylactic Palliative Radiotherapy Experimental Treatment 1 Intervention

Prophylactic Palliative Radiotherapy

Prophylactic Palliative Radiotherapy is already approved in United States, European Union for the following indications:

Approved in United States as Prophylactic Radiation Therapy for:

• Pain relief for symptomatic bone metastases
• Prevention of skeletal-related events (SREs) in asymptomatic bone metastases

Approved in European Union as Palliative Radiotherapy for:

• Symptom control for focal disease due to cancer
• Pain relief for symptomatic bone metastases

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Findings from Research

Recent advances in systemic treatments for stage IV lung cancer have improved options for patients, including those with brain metastases, due to better understanding of how targeted therapies penetrate the central nervous system.

Palliative radiotherapy remains essential for symptom control in lung cancer management, especially in second-line treatments and for patients not suitable for primary systemic therapies, although its role in first-line treatment is still being defined.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Palliative Radiotherapy in the Treatment of Lung Cancer. King, J., Patel, K., Woolf, D., et al.[2023]

A new survival score was developed for patients with locally advanced lung cancer receiving palliative irradiation, based on data from 125 patients and factors like N stage and M stage, which were significantly associated with survival.

The score categorizes patients into three groups with distinct 6-month survival rates: 13% for low scores (10-11 points), 47% for medium scores (12-14 points), and 82% for high scores (15-17 points), helping physicians estimate patient lifespan more accurately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Survival Score for Patients Receiving Palliative Irradiation for Locally Advanced Lung Cancer. Rades, D., Käsmann, L., Schild, SE., et al.[2018]

A study of 82 patients with non-small cell lung cancer and brain metastasis showed that combined chemotherapy and palliative irradiation is effective, with 1-year survival rates of 46.7% overall, and 61.2% for those with only intracranial metastasis.

Patients with brain metastasis and additional extracranial lesions had significantly lower survival rates (32.4% at 1 year), indicating that the presence of multiple metastases negatively impacts outcomes, but no severe complications were reported during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Palliative irradiation combined with chemotherapy for lung cancer with brain metastasis]. Ye, M., Yang, H., Wang, L.[2013]

A study of 384 patients with stage IIIB or IV lung cancer revealed that while many believed radiation therapy (RT) could prolong their lives (78%) and alleviate symptoms (67%), 64% did not realize it was unlikely to cure their cancer.

The findings highlight a significant gap in patient understanding, particularly among older patients and nonwhites, emphasizing the need for better communication about the palliative nature and limitations of RT in treating incurable lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expectations about the effectiveness of radiation therapy among patients with incurable lung cancer. Chen, AB., Cronin, A., Weeks, JC., et al.[2022]

Palliative radiotherapy is effective in quickly alleviating symptoms of advanced cancer, allowing for rapid relief with minimal impact on patients' quality of life.

Dedicated palliative radiotherapy programs have emerged over the past 20 years, focusing on holistic care and addressing patients' broader concerns, which has led to improved patient-focused outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Radiotherapy: Inpatients, Outpatients, and the Changing Role of Supportive Care in Radiation Oncology. Arscott, WT., Emmett, J., Ghiam, AF., et al.[2021]

Radiation therapy is a crucial treatment for cancer patients, with 30% to 50% of treatments aimed at palliative care to relieve symptoms and maintain quality of life.

It is generally effective at targeting localized cancer and has minimal systemic side effects, making it a safe option for managing cancer-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative radiotherapy--new approaches. van Oorschot, B., Rades, D., Schulze, W., et al.[2022]

Palliative radiation therapy is effective in relieving symptoms related to incurable cancer, such as pain, bleeding, and airway obstruction, by targeting either the primary tumor or metastatic lesions.

Various techniques, including external beam radiation and brachytherapy, can be used to deliver palliative radiation, making it a versatile option for managing tumor-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative radiation therapy in oncology. Dolinsky, C., Metz, JM.[2006]

Radiation therapy is a common treatment for breast cancer, with 30-50% of cases being palliative, aimed at relieving symptoms or preventing quality of life deterioration.

Palliative radiotherapy is effective locally and generally causes mild acute side effects, making it a safe option for managing symptoms in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapeutic Options for Symptom Control in Breast Cancer. van Oorschot, B., Beckmann, G., Schulze, W., et al.[2021]

In a study of 338 patients receiving palliative radiotherapy (RT) from April 2015 to April 2018, RT effectively relieved symptoms in 76% of lung cancer patients and over 75% of those with bone metastases, demonstrating its efficacy in managing pain and other symptoms.

The treatment-related toxicity was lower than previously reported, indicating that modern RT technologies improve the quality of life for patients while providing effective symptom control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and Toxicity of Radiation Therapy in Selected Palliative Indications. Pechačová, Z., Zemanová, M., Končeková, J.[2019]

In a study of 52 lung cancer patients treated with split course radiotherapy (50-60 Gy in 18-25 fractions), 63% showed a rapid response to initial treatment, but this did not correlate with improved survival or palliative response rates.

Factors such as being female and receiving systemic therapy after radiotherapy were associated with better survival outcomes, suggesting that while split course radiotherapy is a viable option for palliation, other patient characteristics play a significant role in overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Split course palliative radiotherapy for advanced lung cancer with 3D planning based analysis of outcome: a retrospective review. Bruggeman, AR., Sarkar, RR., Ahn, GS., et al.[2022]

Palliative thoracic radiotherapy is effective for lung cancer patients, providing quick relief for symptoms in about two-thirds of those treated, even in patients with poor performance status.

Higher radiation doses given over longer schedules can offer modest survival benefits for patients with better performance status, highlighting the importance of tailoring treatment plans based on individual patient conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative thoracic radiotherapy for lung cancer. Kepka, L., Olszyna-Serementa, M.[2018]

Palliative radiotherapy has been an effective treatment for nearly 100 years, providing symptom relief for patients with metastatic or advanced cancer, often using short courses or single fractions to minimize side effects and enhance convenience.

Recent advancements in imaging and radiotherapy techniques, such as intensity-modulated radiotherapy (IMRT) and stereotactic radiotherapy (SRT), allow for more effective local control and longer-lasting palliative responses, even in patients who may not yet show symptoms of advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative radiotherapy: current status and future directions. Sharma, S., Hertan, L., Jones, J.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The Use of Palliative Radiotherapy in the Treatment of Lung Cancer. [2023]

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

A Survival Score for Patients Receiving Palliative Irradiation for Locally Advanced Lung Cancer. [2018]

3. China pubmed.ncbi.nlm.nih.gov

[Palliative irradiation combined with chemotherapy for lung cancer with brain metastasis]. [2013]

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

Expectations about the effectiveness of radiation therapy among patients with incurable lung cancer. [2022]

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

Palliative Radiotherapy: Inpatients, Outpatients, and the Changing Role of Supportive Care in Radiation Oncology. [2021]

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

Palliative radiotherapy--new approaches. [2022]

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

Palliative radiation therapy in oncology. [2006]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Radiotherapeutic Options for Symptom Control in Breast Cancer. [2021]

9. Czech Republic pubmed.ncbi.nlm.nih.gov

Effect and Toxicity of Radiation Therapy in Selected Palliative Indications. [2019]

10. China pubmed.ncbi.nlm.nih.gov

Split course palliative radiotherapy for advanced lung cancer with 3D planning based analysis of outcome: a retrospective review. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Palliative thoracic radiotherapy for lung cancer. [2018]

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

Palliative radiotherapy: current status and future directions. [2022]