Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors
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Purpose
Patients with primary hepato-biliary malignancies or liver metastases from gastrointestinal cancer suffer substantial morbidity and mortality from their hepatic disease. Curative resection is feasible only for selected subgroups of patients. The majority of patients have unresectable and incurable disease. Aggressive arterial and systemic chemotherapy have been used in recent years with improved response and survival. However, a significant number of patients, at least one-third of patients with liver metastases from colorectal cancer and two-third or higher of unresectable hepatobiliary cancer, continue to die of liver failure from progressive disease in the liver. Percutaneous ethanol injections, chemoembolization, cryotherapy and thermal ablation using radiofrequency have been used to treat selected patients with smaller tumors (3-4 cm) in areas away from major blood vessels and the biliary tract. However, most unresectable liver cancers did not fit the criteria for these treatments. Therefore, other regional therapeutic option like external radiation therapy may be considered for local control in the liver or symptom palliation
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Tumors |
Radiation: Stereotactic Body Radiation Therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Fractionated Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors |
- Response rate to SBRT [ Time Frame: 3-6 Months ] [ Designated as safety issue: No ]
- Treatment Related Toxicity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 71 |
| Study Start Date: | November 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Eligible patient will be treated with 48 Gy in 4 fractions encompassing the entire target lesion in 2 weeks with a minimum of 48 hours between each dose.
|
Radiation: Stereotactic Body Radiation Therapy
Radiation Dose: 48 Gy in 4 fractions in 2 weeks. A minimum of 48 hours should separate each treatment (e.g. every Tuesday and Friday). The dose is prescribed to the marginal isodose (80-90%) that encompasses the entire target lesion (GTV). Treatment will be delivered using a linear accelerator. For verification of the accuracy of these external skin fiducial markers, 10 patients will also have implanted internal gold coil markers. The implantable gold coil markers will be implanted into the liver in the proximity of the target lesions via a percutaneous transhepatic route under fluoroscopy guidance.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically conformation of liver malignancy
- Solitary or multiple liver tumors amenable to SBRT
- No jaundice or liver dysfunction
- For metastases, the primary tumor site has been adequately treated.
- For primary hepatoma, no extra-hepatic disease
- Karnofsky > 70
Exclusion Criteria:
- no extra-hepatic disease
- Liver failure or inadequate liver function
- Ascites
- Previous radiation therapy to the liver
- lesions invading major blood vessels in the porta region
- Contraindication to receive radiation therapy in the liver
Contacts and Locations| Contact: Robert Nordal, M.D. | 403-521-3095 | Robert.Nordal@albertahealthservices.ca |
| Canada, Alberta | |
| Tom Baker Cancer Centre | Recruiting |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Contact: Robert Nordal, M.D. 403-521-3077 Robert.Nordal@albertahealthservices.ca | |
| Principal Investigator: Robert Nordal, M.D. | |
| Principal Investigator: | Robert Nordal, M.D. | Tom Baker Cancer Centre |
More Information
No publications provided
| Responsible Party: | Dr. Robert Nordal, Tom Baker Cancer Centre |
| ClinicalTrials.gov Identifier: | NCT00691691 History of Changes |
| Other Study ID Numbers: | 18740, 18740 |
| Study First Received: | June 3, 2008 |
| Last Updated: | January 18, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Alberta Health Services:
|
Liver malignancy Stereotactic Body Radiation Therapy Efficacy of SBRT in liver tumors Hepatic toxicity with SBRT |
Additional relevant MeSH terms:
|
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on June 18, 2013