drugset / Trial / NCT00426829
Proton Therapy and Bevacizumab for Primary Liver Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |