Photon vs Proton Radiation for Non-Small Cell Lung Cancer

Recruiting at 29 trial locations

Overseen By Abraham J. Wu

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Radiation Therapy Oncology Group

Disqualifiers: Prior invasive malignancy, COPD, AIDS, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 39

Duration: 7 weeks

330 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.

Do I need to stop taking my current medications to join the 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 Photon vs Proton Radiation for Non-Small Cell Lung Cancer?

Proton beam therapy (PBT) for non-small cell lung cancer has shown to reduce radiation exposure to the heart and lungs compared to photon therapy, without worsening disease control. Additionally, PBT may offer lower rates of side effects and potential survival benefits, although more research is needed to confirm these findings. ^{1 2 3 4 5}

Is proton beam therapy safe for treating non-small cell lung cancer?

Proton beam therapy generally shows lower rates of side effects compared to traditional photon therapy, as it delivers less radiation to nearby healthy organs like the lungs and heart. Studies suggest it may reduce the risk of harmful effects while maintaining effective disease control. ^{1 3 5 6 7}

How does the treatment of photon vs proton radiation for non-small cell lung cancer differ from other treatments?

Proton beam therapy is unique because it can deliver high doses of radiation directly to the tumor while minimizing damage to surrounding healthy tissues, potentially reducing side effects compared to traditional photon radiation therapy. ^{1 2 5 8 9}

Research Team

Zhongxing Liao

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with stage II-IIIB non-small cell lung cancer that can't be surgically removed. They should have acceptable organ function, no severe illnesses, and not have had certain previous cancer treatments. Women who can bear children must test negative for pregnancy and all participants must agree to use contraception.

Inclusion Criteria

My lung cancer diagnosis was confirmed through lab tests.

My nerve damage symptoms are mild or not present.

I am a woman who can have children and I have a negative pregnancy test from the last 14 days.

Exclusion Criteria

I am not pregnant and willing to use contraception if of childbearing potential.

I've had radiation in the same area as my current cancer.

I've had more than 4 cycles of chemo or over 6 months of targeted therapy for my cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo photon or proton beam radiation therapy 5 days per week for a total of 35 fractions, with concurrent chemotherapy

7 weeks

35 visits (in-person)

Consolidation Therapy

Beginning 3-6 weeks after chemoradiotherapy, patients receive additional chemotherapy or immunotherapy

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Long-term

Follow-up at 4-8 weeks, every 3 months for 1 year, every 6 months for 1 year, then annually

Treatment Details

Interventions

• Photon Beam Radiation Therapy
• Proton Beam Radiation Therapy

Trial Overview The study compares two types of radiation therapy (photon vs proton) combined with chemotherapy drugs like paclitaxel and carboplatin to see which is more effective in treating non-operable lung cancer without causing much damage to healthy tissue.

Participant Groups

Group I: Arm II (proton beam radiation therapy and chemotherapy) Experimental Treatment 9 Interventions

Patients undergo proton beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel\* and carboplatin\*, etoposide and cisplatin, or pemetrexed and carboplatin (for non-squamous cell cancer patients only) as in Arm I. Patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy. CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.

Group II: Arm I (photon beam radiation therapy and chemotherapy) Active Control 9 Interventions

Patients undergo photon beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel\* IV over 1 hour and carboplatin\* IV weekly during radiation therapy or etoposide IV on days 1-5 and 29-33 and cisplatin IV on days 1, 8, 29, and 36. Patients with non-squamous cell cancer may receive pemetrexed IV and carboplatin IV on every 21 days. Patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy. CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.

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

Approved in United States as Radiation Therapy for:

• Cancer treatment, including glioblastoma

Approved in European Union as Radiation Therapy for:

• Cancer treatment, including glioblastoma

Approved in Canada as Radiation Therapy for:

• Cancer treatment, including glioblastoma

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials

191

Recruited

64,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Findings from Research

Proton beam therapy for lung cancer significantly reduces the average dose of radiation to the lungs (Dmean) and the volume of lung receiving higher doses (V20, V10, V5) compared to both three-dimensional conformal photon radiotherapy (3D-CRT) and intensity-modulated photon radiotherapy (IMRT), based on an analysis of six clinical trials.

While proton therapy does not lower the average dose to the esophagus, it does reduce the dose to the heart, suggesting a safer profile for patients undergoing lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dosimetric comparing between protons beam and photons beam for lung cancer radiotherapy: a meta-analysis]. Tian, G., Li, N., Li, G.[2021]

Proton beam therapy (PBT) can deliver lower radiation doses to surrounding healthy organs compared to traditional photon (X-ray) radiotherapy, potentially reducing side effects for lung cancer patients.

Early clinical results indicate that PBT, when combined with chemotherapy, shows lower toxicity rates and may improve survival outcomes, although further randomized studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam therapy for locally advanced lung cancer: A review. Schild, SE., Rule, WG., Ashman, JB., et al.[2021]

Proton-beam therapy is an effective treatment option for non-small-cell lung cancer (NSCLC), especially for patients who cannot undergo surgery due to advanced disease or other medical conditions.

This type of radiotherapy allows for precise targeting of tumors, delivering high doses to the cancer while sparing surrounding healthy tissues, making it a promising alternative for lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of proton-beam therapy in the treatment of non-small-cell lung cancer. Oshiro, Y., Sakurai, H.[2013]

References

1. China pubmed.ncbi.nlm.nih.gov

[Dosimetric comparing between protons beam and photons beam for lung cancer radiotherapy: a meta-analysis]. [2021]

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

Proton radiation therapy offers reduced normal lung and bone marrow exposure for patients receiving dose-escalated radiation therapy for unresectable stage iii non-small-cell lung cancer: a dosimetric study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Proton Beam Therapy versus Photon Radiotherapy for Stage I Non-Small Cell Lung Cancer. [2022]

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

Consensus Statement on Proton Therapy in Early-Stage and Locally Advanced Non-Small Cell Lung Cancer. [2022]

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

Proton beam therapy for locally advanced lung cancer: A review. [2021]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Long-term toxic effects of proton radiotherapy for paediatric medulloblastoma: a phase 2 single-arm study. [2022]

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

PRONTOX - proton therapy to reduce acute normal tissue toxicity in locally advanced non-small-cell lung carcinomas (NSCLC): study protocol for a randomised controlled trial. [2018]

9. England pubmed.ncbi.nlm.nih.gov

The use of proton-beam therapy in the treatment of non-small-cell lung cancer. [2013]