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A Phase II Study of Fractionated Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Liver Tumors

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Trial Information

A Phase II Study of Fractionated Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate to SBRT

Outcome Time Frame:

3-6 Months

Safety Issue:

No

Principal Investigator

Robert Nordal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tom Baker Cancer Centre

Authority:

Canada: Ethics Review Committee

Study ID:

18740

NCT ID:

NCT00691691

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Liver Tumors
  • Liver malignancy
  • Stereotactic Body Radiation Therapy
  • Efficacy of SBRT in liver tumors
  • Hepatic toxicity with SBRT
  • Liver Neoplasms

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