186 Participants Needed

Proton vs Photon Therapy for Liver Cancer

Recruiting at 31 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: NRG Oncology
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

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.12345

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.36789

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.1451011

Research Team

TS

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
See 13 more

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.
See 5 more

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
  • Proton Therapy
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Group I: Arm II (photon therapy)Experimental Treatment6 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 Treatment6 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 European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Photon Therapy for:
  • Liver cancer
  • Breast cancer
  • Lung cancer
  • Prostate cancer
  • Brain tumors
🇺🇸
Approved in United States as Photon Therapy for:
  • Liver cancer
  • Breast cancer
  • Lung cancer
  • Prostate cancer
  • Brain tumors
🇨🇦
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials
242
Recruited
105,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Intensity modulated proton therapy (IMPT) showed a significant improvement in dose homogeneity (about 25%) and a 60% reduction in integral dose compared to volumetric modulated arc therapy (VMAT) in a study involving 20 patients with advanced hepatocellular carcinoma.
IMPT also demonstrated better sparing of organs at risk while maintaining target coverage, making it a promising treatment option, although careful management of positioning uncertainties is crucial to avoid potential underdosage.
Critical appraisal of the potential role of intensity modulated proton therapy in the hypofractionated treatment of advanced hepatocellular carcinoma.Cozzi, L., Comito, T., Fogliata, A., et al.[2023]
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.
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]
Proton therapy (IMPT) provides better dose distribution and sparing of healthy tissues compared to photon therapy (IMRT) for pediatric patients with intracranial tumors, particularly benefiting younger patients with supratentorial tumors.
Infratentorial tumors showed significant sparing of the optic chiasm with IMPT, while brainstem sparing was less pronounced, indicating that IMPT can effectively reduce radiation exposure to critical structures in pediatric patients.
Influence of Target Location, Size, and Patient Age on Normal Tissue Sparing- Proton and Photon Therapy in Paediatric Brain Tumour Patient-Specific Approach.Dell'Oro, M., Short, M., Wilson, P., et al.[2020]

References

Critical appraisal of the potential role of intensity modulated proton therapy in the hypofractionated treatment of advanced hepatocellular carcinoma. [2023]
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]
Influence of Target Location, Size, and Patient Age on Normal Tissue Sparing- Proton and Photon Therapy in Paediatric Brain Tumour Patient-Specific Approach. [2020]
Proton versus photon radiotherapy for hepatocellular carcinoma: Current data and technical considerations. [2023]
Proton versus photon radiotherapy for primary hepatocellular carcinoma: a propensity-matched analysis. [2021]
Proton beam therapy for liver cancers. [2020]
Proton radiation therapy for head and neck cancer. [2018]
Intensity Modulated Proton Therapy for Hepatocellular Carcinoma: Initial Clinical Experience. [2022]
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 Statespubmed.ncbi.nlm.nih.gov
Dosimetric Comparison of Plans for Photon- or Proton-Beam Based Radiosurgery of Liver Metastases. [2022]
Charged particle therapy versus photon therapy for patients with hepatocellular carcinoma: a systematic review and meta-analysis. [2022]