HCC Response Assessment by MRI After SBRT

Carcinoma, Hepatocellular Clinical Trial

Official title:

Tumor Response Assessment by MRI Following Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088423
• Other study ID #: 2013_ICL_0001
• Status: Completed
• Phase: N/A
• First received: March 16, 2017
• Last updated: March 17, 2017
• Start date: October 1, 2011
• Est. completion date: February 1, 2015

Study information

• Verified date: March 2017
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this work was to describe SBRT different presentations, to study predictive factors for tumor responses following treatment, and to compare tumor response assessments according to the Response Evaluation Criteria

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 1, 2015
• Est. primary completion date: April 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• Inclusion Criteria: the standard criteria for treating HCC patients with SBRT : an Eastern Cooperative Oncology Group (ECOG) score of 2, inoperable tumors (e.g. the patient being unfit for surgery, or tumor-related contraindications), and a maximum tumor diameter of 6 cm. The HCC diagnosis could be histological or based on the radiological criteria of the American Association for the Study of Liver Diseases (AASLD)

• Exclusion Criteria:no follow-up by MR imaging

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Radiation:
• SBRT delivers high dose selective irradiation with millimeter precision to a small volume. The Cyberknife® is a robotic SBRT dedicated device that can deliver 100 to 200 photobeams to the target
Seven to ten days before the scheduled CT, 2-4 fiducial markers were implanted percutaneously 2 to 5 cm next to the lesion under sonographic guidance following administration of local anesthesia, thus allowing real-time tracking during treatment. The total dose delivered was 45 Gy on the 80% isodose, in three fractions over 10 days. Gross tumor volume (GTV) was defined as the tumor mass that could be discerned by diagnostic imaging. An isotropic margin of 5 mm was added to account for the microscopic extension (clinical target volume, CTV) and another 3 mm margin was added to compensate for uncertainties regarding the position (previsional target volume, PTV)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response assessments	The tumor response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Within the 24 months after SBRT