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Patients undergo proton therapy over 15-24 days for 5 or 15 fractions.

Patients undergo photon therapy over 15-24 days for 5 or 15 fractions.

Proton Therapy (Radiation Therapy)

Photon Therapy (Radiation Therapy)

Site Public Contact

Pretesh R. Patel

Jason K. Molitoris

Theodore S. Hong

John M. Robertson

Jordan Kharofa

Lauren E. Henke

Eugene J. Koay

Smith Apisarnthanarax

Theodore Hong

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.

PRIMARY OBJECTIVES:

I. To determine if Overall Survival (OS) is different for hepatocellular carcinoma patients treated with protons compared to photons.

SECONDARY OBJECTIVES:

I. To determine the difference in Progression-Free Survival (PFS) in patients with hepatocellular carcinoma (HCC) treated with protons compared to patients with HCC treated with photons.

II. To determine the difference in local progression (LP) in patients with HCC treated with protons compared to patients with HCC treated with photons.

III. To determine differences in toxicity in patients with HCC treated with protons versus photons.

IV. To determine differences in fatigue, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue in patients with HCC treated with protons, versus photons; as well as quality-adjusted survival, if the primary endpoint is met.

V. To determine if there are correlations between the baseline values of HGF and outcomes (OS/PFS/fatigue).

EXPLORATORY OBJECTIVES:

I. To determine differences in overall Quality of Life, measured by FACT-Hep in patients with HCC treated with protons.

II. Biospecimen collection for future correlative science projects.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo proton therapy over 15-24 days for 5 or 15 fractions.

ARM II: Patients undergo photon therapy over 15-24 days for 5 or 15 fractions.

After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3 years.

Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer

A Phase III Randomized Trial of Protons Versus Photons for Hepatocellular Carcinoma

OS will be estimated by the Kaplan-Meier method. The distributions of OS between treatment arms will be compared using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, that may be associated with OS.

PFS is defined as local/regional/distant progression or death due to any cause and will be estimated by the Kaplan-Meier method. The distributions of PFS between treatment arms will be compared using the log rank test.

LP will be estimated by the cumulative incidence method and compared using Gray's test. The Fine-Gray regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with LP.

A Chi-square test will be used to compare the number of patients with at least 1 grade 3 or higher adverse events between the treatment arms.

Change in fatigue will be compared between treatment arms using a t-test. If the data do not satisfy the normality assumption, a Wilcoxin test may be used instead.

HGF will be dichotomized at 2311 pg/mL and evaluated for prognostic significance using Cox regression model.

The EuroQol (EQ-5D) will be used to assess quality-adjusted survival.

QOL will be measured by the FACT-Hep v 4. An improvement in the FACT-HEP, defined as an increase of 5 points, will be assessed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer	NCT03186898	Unrectable or L...	Proton Therapy ... Photon Therapy ...	18 Years -	NRG Oncology
Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer	NCT03186898	Unrectable or L...	Proton Therapy ... Photon Therapy ...	18 Years -	NRG Oncology

Spots Global Cancer Trial Database for photon therapy (radiation therapy)