Intense Radiation + Chemotherapy for Lung Cancer

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Proton Collaborative Group

Disqualifiers: Distant metastasis, Prior thoracic radiotherapy, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using standard chemotherapy in combination with hypofractionated proton radiation therapy. Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.

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 study team or your doctor.

What data supports the effectiveness of this treatment for lung cancer?

Research shows that hypofractionated proton therapy, when combined with chemotherapy, can be safely used for treating non-small cell lung cancer (NSCLC) and may improve overall survival. Proton therapy helps target the cancer more precisely, reducing damage to healthy tissues compared to traditional radiation methods. ^{1 2 3 4 5}

Is intense radiation with chemotherapy safe for lung cancer patients?

Research shows that using proton therapy with chemotherapy for lung cancer can be safe, as it may cause less damage to healthy tissues compared to traditional radiation methods. However, there are risks of serious side effects like pneumonitis (lung inflammation) and esophagitis (inflammation of the esophagus) with this treatment. ^{1 2 5 6 7}

How is the treatment of intense radiation and chemotherapy for lung cancer different from other treatments?

This treatment uses hypofractionated proton therapy, which delivers higher doses of radiation in fewer sessions, potentially reducing side effects compared to traditional photon therapy. Proton therapy allows for more precise targeting of tumors, which may improve safety and effectiveness in treating locally advanced non-small cell lung cancer. ^{1 8 9 10 11}

Research Team

Brad Hoppe, MD

Principal Investigator

Proton Collaborative Group

Eligibility Criteria

This trial is for adults with stage II-III non-small cell lung cancer who can't have surgery. They should be in good physical condition, not pregnant, willing to use contraception, and haven't lost a lot of weight recently. No prior chest radiation or evidence of cancer spread far from the lung is allowed.

Inclusion Criteria

Your lab test results must be from within the 4 weeks before you join the study.

Your white blood cell count must be higher than 1,800 cells/mm3.

You have at least 100,000 platelets per cubic millimeter of blood.

Exclusion Criteria

I have had radiation therapy to my chest area before.

I have lost more than 10% of my weight without trying in the last month.

I am not pregnant or breastfeeding and willing to use contraception during and for 12 months after the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hypofractionated proton therapy with concurrent chemotherapy

6-8 weeks

Weekly visits for radiation treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Concurrent Chemotherapy
• Hypofractionated Proton Therapy

Trial Overview The study tests if giving higher daily doses of proton radiation therapy over fewer days (hypofractionation) combined with standard chemotherapy works better for treating non-small cell lung cancer than current methods.

Participant Groups

Group I: Proton Radiotherapy with Chemotherapy Experimental Treatment 1 Intervention

Concurrent Chemotherapy is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Concurrent Chemotherapy for:

• Locally advanced cervical cancer

Approved in Canada as Concurrent Chemotherapy for:

• Locally advanced cervical cancer

Approved in European Union as Concurrent Chemotherapy for:

• Locally advanced cervical cancer

Who Is Running the Clinical Trial?

Proton Collaborative Group

Lead Sponsor

Trials

10

Recruited

41,100+

Findings from Research

In a phase 1/2 trial involving 28 patients with locally advanced non-small cell lung cancer (NSCLC), hypofractionated proton therapy combined with chemotherapy resulted in impressive 1-year overall survival rates of 89%, significantly higher than the 62% benchmark from previous studies.

The treatment was well-tolerated, with no severe esophagitis and only 14% of patients experiencing significant radiation-related pulmonary toxicity, suggesting that proton therapy may offer a safer alternative for patients with advanced NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemoradiation with Hypofractionated Proton Therapy in Stage II-III Non-Small Cell Lung Cancer: A Proton Collaborative Group Phase 2 Trial. Hoppe, BS., Nichols, RC., Flampouri, S., et al.[2022]

The phase 1 trial involving 18 patients with stage II or III non-small cell lung cancer demonstrated that hypofractionated proton therapy combined with chemotherapy has an acceptable safety profile, with no severe adverse events attributed to radiation therapy.

The study did not identify a maximum tolerated dose, and while two severe adverse events occurred, they were linked to chemotherapy rather than the proton therapy, suggesting that this treatment approach is safe for further investigation in phase 2 trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Proton Therapy with Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Phase 1 Trial from the University of Florida and Proton Collaborative Group. Hoppe, BS., Nichols, RC., Flampouri, S., et al.[2021]

In a study of 111 patients with early-stage lung cancer, hypofractionated proton beam therapy showed improved overall survival rates with higher doses, achieving a 4-year overall survival of 51% at the 70 Gy dose level.

The treatment was well-tolerated, with no significant complications from radiation pneumonitis, and pulmonary function remained stable one year after therapy, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose hypofractionated proton beam radiation therapy is safe and effective for central and peripheral early-stage non-small cell lung cancer: results of a 12-year experience at Loma Linda University Medical Center. Bush, DA., Cheek, G., Zaheer, S., et al.[2018]

In a study of 20 patients with central lung cancer treated with high total dose hypofractionated proton beam therapy, there were no severe toxicities (Grade 3 or higher), indicating a strong safety profile for this treatment approach.

The therapy resulted in a 2-year overall survival rate of 73.8% and a local control rate of 78.5%, demonstrating its efficacy, especially in operable patients who had a 100% survival rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Dose Hypofractionated Proton Beam Therapy is a Safe and Feasible Treatment for Central Lung Cancer. Ono, T., Yabuuchi, T., Nakamura, T., et al.[2019]

Accelerated hypofractionated radiotherapy (AHR) combined with chemotherapy showed a high overall response rate of 82% in patients with locally advanced non-small-cell lung cancer (NSCLC), indicating its efficacy as a treatment option.

Despite some acute side effects, including severe neutropenia in 70% of patients, the treatment was generally well-tolerated, with no severe long-term side effects reported, suggesting it is a feasible and acceptable approach for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated hypofractionated radiotherapy plus chemotherapy for inoperable locally advanced non-small-cell lung cancer: final results of a prospective phase-II trial with a long-term follow-up. Parisi, E., Genestreti, G., Sarnelli, A., et al.[2020]

References

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

Chemoradiation with Hypofractionated Proton Therapy in Stage II-III Non-Small Cell Lung Cancer: A Proton Collaborative Group Phase 2 Trial. [2022]

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

Hypofractionated Proton Therapy with Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Phase 1 Trial from the University of Florida and Proton Collaborative Group. [2021]

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

Accelerated dose escalation with proton beam therapy for non-small cell lung cancer. [2021]

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

High-dose hypofractionated proton beam radiation therapy is safe and effective for central and peripheral early-stage non-small cell lung cancer: results of a 12-year experience at Loma Linda University Medical Center. [2018]

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

Hypofractionated proton beam radiotherapy for stage I lung cancer. [2018]

6. Poland pubmed.ncbi.nlm.nih.gov

High Dose Hypofractionated Proton Beam Therapy is a Safe and Feasible Treatment for Central Lung Cancer. [2019]

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

Early findings on toxicity of proton beam therapy with concurrent chemotherapy for nonsmall cell lung cancer. [2022]

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

Accelerated hypofractionated radiotherapy plus chemotherapy for inoperable locally advanced non-small-cell lung cancer: final results of a prospective phase-II trial with a long-term follow-up. [2020]

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

[Concurrent chemoradiation in lung cancer]. [2011]

10. Ireland pubmed.ncbi.nlm.nih.gov

Induction or consolidation systemic therapy in the multimodality treatment of unresectable locally advanced non-small cell lung cancer. [2019]

11. France pubmed.ncbi.nlm.nih.gov

[Radiochemotherapy and radiosensitization for locally advanced non-small-cell bronchial cancer]. [2019]