Actively Recruiting
Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases
Led by University of Sao Paulo · Updated on 2024-12-09
43
Participants Needed
1
Research Sites
656 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo
Lead Sponsor
I
Instituto do Cancer do Estado de São Paulo
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of extra-hepatic disease or have disease that is planned to be treated with curative intent. Therefore, SBRT is being considered as a potentially curative procedure.
CONDITIONS
Official Title
Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Adequate bone marrow function defined as platelets > 100,000 cells / mm 3
- Adequate bone marrow function defined as hemoglobin > 8.0 g / dl (transfusion or other intervention accepted)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Instituto do Cancer do Estado de São Paulo
São Paulo, São Paulo, Brazil, 01246-000
Actively Recruiting
Research Team
A
Andre TC Chen, MD, PhD
CONTACT
K
Karina Moutinho, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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