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Protocol # 17-733

Status

Recruiting

Description

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.

Condition

  • Unrectable or Locally Recurrent Hepatocellular Carcinoma

Interventions

  • Proton Therapy (Radiation Therapy)
  • Photon Therapy (Radiation Therapy)

Phase

Phase 3

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Overall Survival (OS)

Secondary Outcome:

  • Progression-Free Survival (PFS)
  • Local Progression (LP)
  • Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 5
  • Fatigue as measured by the PROMIS fatigue short form version 1.0 8a
  • Correlation of Hepatocyte Growth Factor (HGF) biomarker with OS, PFS and fatigue
  • Quality Adjusted Survival (if primary endpoint is met)
  • Exploratory - Overall Quality of Life (QOL)

Enrollment

186

Study Start Date

June 22, 2017

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

NRG Oncology

Source

NRG Oncology

Official title

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

Clinicaltrials.gov Identifier

NCT03186898

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.