NCT00662246

Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma

A Phase I Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The radical treatment for Hepatocellular carcinoma (HCC) is surgery. However, it is only for 10 to 20% of all patients and 10 to 30% of them have relapsed every year after surgery. For an inoperable case, we can consider Liver transplantation. But there is not enough organ donor and it is very expensive. In that case, various treatment modalities for HCC (i.e., transcatheter arterial embolization \[TAE\] and percutaneous ethanol injection \[PEI\], radiofrequency ablation etc.) have become clinically available. In addition, after these treatment, radiation therapy can be conducted as a combined treatment. If it is difficult, radiation therapy can be conducted alone. In this case, radiation therapy can use fractionated stereotactic radiation therapy \[FSRT\] or 3D simulation to minimize the exposure to normal tissues. In recent years, Proton therapy is a new radiation therapy which remaining energy is released when they reach the tumor, delivering the most effective dose of radiation. The purpose of this trial is to improve the therapeutic effects by using proton therapy.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
RADIATION	respiratory gated proton beam radiotherapy	\- Prescription dose to PTV as according to the following dose escalation schema: Dose level 1: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 72 GyE /24 fx, 3GyE fraction dose, 5 days/week.

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-04-21
• Last updated: 2012-04-03

Locations

1 site across 1 country: South Korea