NCT03186898

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

Active, enrolled Phase 3 Last updated 3 April 2026

What this trial tests

Phase 3 trial testing Biospecimen Collection in Recurrent Hepatocellular Carcinoma in 186 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 January 2018

Primary endpoint
30 June 2027

30 June 2027

Quick facts

Lead sponsor	NRG Oncology
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	186
Start date	26 January 2018
Primary completion	30 June 2027
Estimated completion	30 June 2027
Sites	27 locations across United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Computed Tomography
• Laboratory Biomarker Analysis — full drug profile →
• Magnetic Resonance Imaging
• Quality-of-Life Assessment
• Radiation Therapy — full drug profile →
• Radiation Therapy — full drug profile →

Conditions studied

• Recurrent Hepatocellular Carcinoma — all drugs for Recurrent Hepatocellular Carcinoma →
• Stage III Hepatocellular Carcinoma AJCC v7 — all drugs for Stage III Hepatocellular Carcinoma AJCC v7 →
• Unresectable Hepatocellular Carcinoma — all drugs for Unresectable Hepatocellular Carcinoma →

Sponsor

NRG Oncology — full company profile →

Who can join

18 and older, any sex, with Recurrent Hepatocellular Carcinoma or Stage III Hepatocellular Carcinoma AJCC v7. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiation-Induced Liver Disease and Modern Radiotherapy.
   Koay EJ, Owen D, Das P. · · 2018 · cited 117× · PMID 30309642 · DOI 10.1016/j.semradonc.2018.06.007
2. A Review of Proton Therapy - Current Status and Future Directions.
   Mohan R. · · 2022 · cited 115× · PMID 36160180 · DOI 10.1002/pro6.1149
3. Proton beam therapy for cancer in the era of precision medicine.
   Hu M, Jiang L, Cui X, Zhang J, et al · · 2018 · cited 57× · PMID 30541578 · DOI 10.1186/s13045-018-0683-4
4. Stereotactic body radiation therapy for hepatocellular carcinoma: From infancy to ongoing maturity.
   Lewis S, Dawson L, Barry A, Stanescu T, et al · · 2022 · cited 55× · PMID 35860434 · DOI 10.1016/j.jhepr.2022.100498
5. Proton beam therapy versus stereotactic body radiotherapy for hepatocellular carcinoma: practice patterns, outcomes, and the effect of biologically effective dose escalation.
   Hasan S, Abel S, Verma V, Webster P, et al · · 2019 · cited 52× · PMID 31602338 · DOI 10.21037/jgo.2019.08.03
6. Radiotherapy for HCC: Ready for prime time?
   Bang A, Dawson LA. · · 2019 · cited 51× · PMID 32039361 · DOI 10.1016/j.jhepr.2019.05.004
7. Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma: Current Trends and Controversies.
   Schaub SK, Hartvigson PE, Lock MI, Høyer M, et al · · 2018 · cited 51× · PMID 30068240 · DOI 10.1177/1533033818790217
8. Proton versus photon radiation therapy: A clinical review.
   Chen Z, Dominello MM, Joiner MC, Burmeister JW. · · 2023 · cited 32× · PMID 37064131 · DOI 10.3389/fonc.2023.1133909