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Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases
Conditions
Liver Metastases - Colorectal Cancer - Anal Canal Cancer - Gastrointestinal Neuroendocrine Tumors
Conditions: official terms
Apudoma - Carcinoid Tumor - Liver Neoplasms - Neoplasm Metastasis - Neuroendocrine Tumors
Conditions: Keywords
SBRT, radiation, Neoplasm Metastasis, Colorectal Neoplasms, Anal Canal, Neuroendocrine Tumors
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: SBRT
Type: Radiation
Overall Status
Recruiting
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 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.
Therefore, SBRT is being considered as a potentially curative procedure.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
- 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
Location
Instituto do Cancer do Estado de São Paulo
São Paulo, SP, Brazil
Status: Recruiting
Contact: Andre TC Chen, MD - 55-11-3893-4540 - andre.chen@hc.fm.usp.br
Start Date
May 2014
Completion Date
May 2021
Sponsors
University of Sao Paulo
Source
University of Sao Paulo
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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