Status:
RECRUITING
Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Instituto do Cancer do Estado de São Paulo
Conditions:
Liver Metastases
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02185443
Start Date
May 1 2014
End Date
December 1 2026
Last Update
December 9 2024
Active Locations (1)
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1
Instituto do Cancer do Estado de São Paulo
São Paulo, São Paulo, Brazil, 01246-000