CPAP or Deep Inspiration Breath Hold for Lung Cancer

Overseen By Julianne M. Pollard, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Reduced consciousness, Facial trauma, IPF, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 10 days

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot phase I/II trial studies how well a continuous positive airway pressure device or deep inspiration breath hold works in reducing tumor movement in patients undergoing stereotactic body radiation therapy (SBRT) for lung cancer. The continuous positive airway pressure device works by blowing air into the lungs while patients wear a face mask or nozzle to help expand their airways and lungs. Deep inspiration breath hold is a standard technique that uses active breath-holding to restrict movement of the body. Using a continuous positive airway pressure device may work better than deep inspiration breath hold in lowering the amount of tumor movement during stereotactic radiation body therapy.

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

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 data supports the effectiveness of the treatment CPAP or Deep Inspiration Breath Hold for Lung Cancer?

Research shows that stereotactic ablative radiotherapy (SABR), particularly using the CyberKnife system, is effective for treating early-stage non-small cell lung cancer, offering high rates of local tumor control with minimal side effects. Additionally, using continuous positive airway pressure (CPAP) during SABR can improve lung and heart protection by increasing lung volume and reducing tumor movement. ^{1 2 3 4 5}

Is stereotactic ablative radiotherapy (SABR) using CyberKnife safe for treating lung cancer?

Stereotactic ablative radiotherapy (SABR) using the CyberKnife system has been shown to have acceptable safety levels with low toxicity for treating early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery. However, very high doses for central lung tumors can lead to significant toxicity, so dose adjustments are important to reduce risks. ^{1 2 6 7 8}

How is the treatment using CPAP or Deep Inspiration Breath Hold with Stereotactic Body Radiation Therapy for lung cancer different from other treatments?

This treatment is unique because it combines CPAP (a method to keep airways open) or deep inspiration breath hold with Stereotactic Body Radiation Therapy (a precise form of radiation) to better target lung tumors while minimizing damage to surrounding healthy tissue. It is particularly beneficial for patients who cannot undergo surgery, offering high tumor control with a shorter treatment duration. ^{1 2 4 9 10}

Research Team

Julianne M. Pollard

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for lung cancer patients who will receive thoracic SBRT at MD Anderson and have a CT-visible tumor. It's not for those with reduced consciousness, contraindications to CPAP use, no consent given, uncooperative behavior, recent facial or upper body surgery, or idiopathic pulmonary fibrosis.

Inclusion Criteria

My lung cancer or its spread to the lung is visible on a CT scan.

I will get a specific type of radiation therapy at MD Anderson.

Exclusion Criteria

The patient has sustained trauma or burns to the face.

I have not had surgery on my face, esophagus, stomach, or sinuses in the last 3 months.

The patient has not signed a study-specific informed consent for this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

CT Simulation

Patients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergoes BiPAP CT simulation.

1 day

1 visit (in-person)

Treatment

Patients receive SBRT using the chosen method (CPAP/BiPAP or DIBH) over 30-60 minutes.

Up to 10 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Biphasic Positive Airway Pressure
• Computed Tomography
• Continuous Positive Airway Pressure
• Deep Inspiration Breath Hold
• Radiation Therapy Treatment Planning and Simulation
• Stereotactic Body Radiation Therapy

Trial Overview The study compares the effectiveness of a CPAP device versus deep inspiration breath hold in reducing tumor movement during lung cancer treatment with SBRT. The goal is to see if CPAP can better restrict tumor motion than the standard breath-holding technique.

Participant Groups

Group I: Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP) Experimental Treatment 6 Interventions

Patients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergo BiPAP CT simulation. The attending physician then compares all 3 simulation treatment plans (free-breathing, DIBH, and CPAP/BiPAP) and determines which method to use during SBRT. If CPAP/BiPAP is chosen as preferred method, patients wear CPAP/BiPAP over 1 hour prior to SBRT, then again during SBRT over 30-60 minutes. All other patients complete free-breathing or DIBH during SBRT over 30-60 minutes.

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive 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+

Findings from Research

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[2022]

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 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]

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 radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., 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]

References

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

CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022]

2. Switzerland 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. [2020]

3. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Effect of continuous positive airway pressure administration during lung stereotactic ablative radiotherapy: a comparative planning study. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

Collaborative implementation of stereotactic ablative body radiotherapy: A model for the safe implementation of complex radiotherapy techniques in Australia. [2020]

6. Greece pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]

7. United States 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy for lung cancer. [2018]

9. France pubmed.ncbi.nlm.nih.gov

Deep inspiratory breath hold assisted by continuous positive airway pressure ventilation for lung stereotactic body radiotherapy. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Deep inspiration breath hold in locally advanced lung cancer radiotherapy: validation of intrafractional geometric uncertainties in the INHALE trial. [2022]