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Stereotactic Body Radiation Therapy (SBRT) Hepatocellular Carcinoma (COLD 2)

NCT00914355 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2021-10-06

No results posted yet for this study

Summary

This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce tumour size, slow progression of the disease, prolong life and improve quality of life of patients with hepatocellular carcinoma, a cancer of the liver, that cannot be removed surgically (unresectable) and cannot be treated with ablative therapy (e.g. radio-frequency ablation) or trans-arterial chemo-embolization (TACE) therapy (delivery of chemotherapy through an artery that feeds into the liver). SBRT is concentrated focused radiation therapy delivered very precisely to the liver tumour. It is hoped that knowledge obtained from this study will improve our ability to treat patients with liver tumours that cannot be treated with surgery and other methods, and that SBRT may prove to be a treatment that can lead to long-term and permanent control of liver tumours for some patients.

Conditions

Interventions

RADIATION

Stereotactic Body Radiation

Radiation therapy will be delivered on six occasions, over two weeks. Each treatment will take approximately 30 minutes to deliver.You may be asked to swallow 250 cc of oral contrast before each radiation therapy treatment.Pepto Bismol (a liquid that coats the stomach and is used to treat heartburn) and/or water may be combined with the contrast to improve the quality of the stomach's image.

Sponsors & Collaborators

  • Princess Margaret Hospital, Canada

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Laura Dawson, MD · University Health Network, Princess Margaret Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2020-08-31
Completion
2020-12-08

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT00914355 on ClinicalTrials.gov