Proton vs Photon Therapy for Liver Cancer

Recruiting in Palo Alto (17 mi)

+31 other locations

Overseen by Theodore S Hong

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: NRG Oncology

Disqualifiers: Extrahepatic tumor, Uncontrolled malignancy, Pregnancy, HIV, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase III trial studies how well radiation therapy with protons works compared with photons in treating patients with liver cancer. Radiation therapy, such as photon therapy, uses high energy x-rays to send the radiation inside the body to the tumor while proton therapy uses a beam of proton particles. Proton therapy can stop shortly after penetrating through the tumor and may cause less damage to the surrounding healthy organs and result in better survival in patients with liver cancer.

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

The trial information does not specify if you need to stop taking your current medications. However, it mentions that systemic chemotherapy for the study cancer must not have been given within 2 weeks prior to registration, which might imply a need to pause certain treatments. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Proton vs Photon Therapy for Liver Cancer?

Research suggests that proton therapy may have advantages over photon therapy for liver cancer, as it can better spare healthy liver tissue, potentially reducing side effects and allowing for higher doses of radiation. However, while some studies show promising results, more clinical evidence is needed to confirm these benefits. ^{1 2 3 4 5}

Is proton therapy generally safe for treating liver cancer and other conditions?

Proton therapy is generally considered safe and has been shown to deliver less radiation to nearby healthy organs compared to traditional X-ray therapy, reducing the risk of side effects. It has been used successfully with minimal toxicity in treating liver cancer and other conditions like head and neck cancers. ^{3 6 7 8 9}

How does proton therapy differ from photon therapy for liver cancer treatment?

Proton therapy is unique because it can better spare healthy liver tissue compared to photon therapy, which is important for patients with liver cancer who often have underlying liver disease. This sparing ability may allow for higher doses of radiation to be used safely, potentially improving treatment outcomes. ^{1 4 5 10 11}

Research Team

Theodore S Hong

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with liver cancer who have up to three tumors, meeting specific size requirements. They must have adequate organ function, may have had previous treatments like chemotherapy or surgery, and need a performance status showing they can carry out daily activities. Pregnant women or those not using contraception are excluded.

Inclusion Criteria

Albumin >= 2.5mg/dl

Creatinine < 2 mg/dl

Study-specific informed consent prior to study registration

Exclusion Criteria

I have a history of cancer that is not currently under control.

I have had radiation therapy on the cancer area being studied.

I cannot confirm if my insurance covers the treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo proton or photon therapy over 15-24 days for 5 or 15 fractions, with CT scan, MRI, and blood sample collection throughout the study

3-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Every 3 months for 2 years, every 6 months for 3 years, then yearly

Treatment Details

Interventions

• Photon Therapy (Photon Therapy)
• Proton Therapy (Proton Beam Therapy)

Trial Overview The study compares two types of radiation therapy: photon therapy (high energy x-rays) and proton therapy (proton particles). Proton therapy might cause less damage to healthy organs around the tumor and potentially improve survival rates in liver cancer patients.

Participant Groups

Group I: Arm II (photon therapy) Experimental Treatment 6 Interventions

Patients undergo photon therapy over 15-24 days for 5 or 15 fractions. Patients undergo CT scan, MRI and blood sample collection throughout the study.

Group II: Arm I (proton therapy) Experimental Treatment 6 Interventions

Patients undergo proton therapy over 15-24 days for 5 or 15 fractions. Patients undergo CT scan, MRI and blood sample collection throughout the study.

Photon Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Photon Therapy for:

• Liver cancer
• Breast cancer
• Lung cancer
• Prostate cancer
• Brain tumors

Approved in Japan as Photon Therapy for:

• Liver cancer
• Breast cancer
• Lung cancer
• Prostate cancer
• Brain tumors

Approved in China as Photon Therapy for:

• Liver cancer
• Breast cancer
• Lung cancer
• Prostate cancer
• Brain tumors

Approved in Switzerland as Photon Therapy for:

• Liver cancer
• Breast cancer
• Lung cancer
• Prostate cancer
• Brain tumors

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

Pencil-beam scanning intensity modulated proton therapy (IMPT) for localized pancreatic cancer showed significant reductions in radiation exposure to surrounding organs at risk, such as the small bowel and liver, compared to volumetric modulated arc therapy (VMAT).

No patients experienced severe (grade ≥3) treatment-related adverse events, and there was no significant change in health-related quality of life scores during treatment, indicating that IMPT is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with intensity modulated proton therapy for intact, clinically localized pancreas cancer: Clinical implementation, dosimetric analysis, acute treatment-related adverse events, and patient-reported outcomes. Jethwa, KR., Tryggestad, EJ., Whitaker, TJ., et al.[2022]

Intensity modulated proton therapy (IMPT) demonstrated a high local control rate of 94% and an overall survival rate of 78% in a study of 37 patients with hepatocellular carcinoma (HCC) over a median follow-up of 21 months.

The treatment was found to be safe, with only 3% of patients experiencing significant acute toxicity, and 16% showing a minor increase in liver function scores, indicating that IMPT is a feasible option for HCC management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity Modulated Proton Therapy for Hepatocellular Carcinoma: Initial Clinical Experience. Bhangoo, RS., Mullikin, TC., Ashman, JB., et al.[2022]

Proton beam therapy (PBT) is safer than X-ray therapy (XRT) for liver cancer treatment because it delivers a lower dose of radiation to surrounding healthy organs, which is crucial in reducing the risk of radiation-induced liver disease (RILD).

PBT has demonstrated excellent long-term tumor control with minimal toxicity in patients with hepatocellular carcinoma (HCC) and is increasingly being used effectively for unresectable cholangiocarcinoma and liver metastases, particularly for larger tumors that are not suitable for XRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam therapy for liver cancers. Chuong, M., Kaiser, A., Molitoris, J., et al.[2020]

Proton radiation therapy, particularly intensity-modulated proton therapy (IMPT), offers better dose localization compared to conventional photon radiation therapy, potentially reducing damage to surrounding healthy tissues in patients with head and neck and skull base tumors.

Initial clinical experiences suggest that IMPT may lead to fewer acute and long-term toxicities, and ongoing multi-institutional trials aim to further establish its effectiveness in treating these complex tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton radiation therapy for head and neck cancer. Chan, AW., Liebsch, NJ.[2018]

Intensity modulated proton beam therapy (IMPT) shows a clinically significant dosimetric advantage over intensity modulated photon therapy (IMRT) for esophageal cancer, particularly in sparing the heart and lungs, but both treatments resulted in similar acute toxicities and short-term clinical outcomes.

In a study of 64 patients, IMPT demonstrated comparable local control, progression-free survival, and overall survival rates to IMRT, indicating that IMPT is a safe and effective option for treating esophageal cancer, although longer follow-up is needed to fully assess its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Toxicities and Short-Term Patient Outcomes After Intensity-Modulated Proton Beam Radiation Therapy or Intensity-Modulated Photon Radiation Therapy for Esophageal Carcinoma: A Mayo Clinic Experience. Bhangoo, RS., DeWees, TA., Yu, NY., et al.[2022]

References

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

Critical appraisal of the potential role of intensity modulated proton therapy in the hypofractionated treatment of advanced hepatocellular carcinoma. [2023]

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

Initial experience with intensity modulated proton therapy for intact, clinically localized pancreas cancer: Clinical implementation, dosimetric analysis, acute treatment-related adverse events, and patient-reported outcomes. [2022]

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

Influence of Target Location, Size, and Patient Age on Normal Tissue Sparing- Proton and Photon Therapy in Paediatric Brain Tumour Patient-Specific Approach. [2020]

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

Proton versus photon radiotherapy for hepatocellular carcinoma: Current data and technical considerations. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Proton versus photon radiotherapy for primary hepatocellular carcinoma: a propensity-matched analysis. [2021]

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

Intensity Modulated Proton Therapy for Hepatocellular Carcinoma: Initial Clinical Experience. [2022]

7. China pubmed.ncbi.nlm.nih.gov

Proton beam therapy for liver cancers. [2020]

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

Proton radiation therapy for head and neck cancer. [2018]

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

Acute Toxicities and Short-Term Patient Outcomes After Intensity-Modulated Proton Beam Radiation Therapy or Intensity-Modulated Photon Radiation Therapy for Esophageal Carcinoma: A Mayo Clinic Experience. [2022]

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

Dosimetric Comparison of Plans for Photon- or Proton-Beam Based Radiosurgery of Liver Metastases. [2022]

11. Ireland pubmed.ncbi.nlm.nih.gov

Charged particle therapy versus photon therapy for patients with hepatocellular carcinoma: a systematic review and meta-analysis. [2022]