NCT00243841

Dose Escalation Study for Primary Hepatocellular Carcinoma

Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose of limited fractions of large dose radiation in an effort to achieve a biologically potent cancer therapy in selected patients with primary hepatocellular carcinoma.

Detailed description

Despite recent advances in early detection and diagnosis, only 30-40% of patients with hepatocellular carcinoma may benefit from radical therapies. Liver transplantation offers the best chance for cure. Surgical resection has been the only other potentially curative option, but the majority of patients are not candidates for resection. This reflects the usual comorbidity of severe underlying liver disease that either precludes surgery or makes the surgical approach extremely dangerous.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation	Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.

Timeline

• Start date: 2004-05-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2005-10-25
• Last updated: 2018-12-13
• Results posted: 2018-12-13

Locations

1 site across 1 country: United States