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Proton Therapy and Bevacizumab for Primary Liver Tumors

NCT00426829 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2012-08-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bevacizumab

10 mg/kg by vein every 14 days +/- 2 days, starting on day 1.

RADIATION

Proton Radiation Therapy

3 Gy dose/fraction x 20 fractions.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Sunil Krishnan, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00426829 on ClinicalTrials.gov