Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

Launched by UNIVERSITY OF SAO PAULO · Jul 8, 2014

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Stereotactic Body Radiation Therapy (SBRT) for patients with liver tumors caused by certain types of cancer, including colorectal cancer and anal canal cancer, as well as gastrointestinal neuroendocrine tumors. The goal is to see if SBRT can effectively treat these liver tumors when surgery isn't an option. The trial is looking for patients between the ages of 65 and 74 who have 1 to 4 liver tumors that are too risky to remove surgically and who do not have cancer spread to other parts of the body.

To participate, patients should have a good level of health, as measured by the Karnofsky Performance Scale, and should not have had recent chemotherapy or other treatments that could interfere with the study. Participants can expect to receive targeted radiation therapy aimed at shrinking or controlling their liver tumors, and the trial is currently recruiting patients. It's important to note that this treatment is being explored as a potentially curative option for those who meet the study criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Karnofsky Performance Scale (KPS) equal or greater than 70
• • 1 to 4 liver metastases with an individual maximum diameter of up to 5 cm
• • Lesions considered unresectable or patients considered unfit for surgery
• • Histology of the primary tumor: colorectal adenocarcinoma, carcinoma of the anal canal or gastrointestinal neuroendocrine tumors.
• • Absence of evidence of extra-hepatic disease or extra-hepatic disease to be treated with curative intent.
• • Minimum interval of 2 weeks between systemic chemotherapy and SBRT.
• * Adequate bone marrow function defined as:
• • absolute neutrophils count \> 1,800 cells / mm 3
• • platelets \> 100,000 cells / mm 3
• • hemoglobin \> 8.0 g / dl ( transfusion or other intervention accepted)
• Exclusion Criteria:
• • Concomitant chemotherapy
• • Prior radiotherapy to the upper abdomen
• • Pregnancy
• • Underlying Cirrhosis
• • Active hepatitis or clinically significant liver failure
• • Prior invasive neoplasm except for non-melanoma skin cancer, or unless more than five years without evidence of disease
• • Severe Comorbidity
• • Current anticoagulant treatment