drugset / Trial / NCT00426829

Proton Therapy and Bevacizumab for Primary Liver Tumors

NCT00426829 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Primary Objectives: 1. To evaluate the safety of the treatment of patients with technically or medically inoperable hepatocellular carcinoma and cholangiocarcinoma with proton therapy and concurrent bevacizumab biotherapy. 2. To identify the maximum tolerated dose (MTD) using this combination. Secondary Objectives: 1. To evaluate local control rate within the radiation field, hepatic control rate outside the treatment field, time to radiographic progression and 2 year survival rate. 2. To analyze dose-volume characteristics that influence the development of radiation induced liver disease (RILD) and GI bleeds that may occur. 3. To assess quality of life during and after chemoradiation therapy.

Timeline

Start
2007-05
Primary completion
2009-11
Completion
2009-11

Outcome

Outcome not reported

Stopped: “Low Accural”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous