Tests radiation therapy for cancer that has spread to the liver
Tests focused radiation on liver tumors in adults with colorectal, anal or neuroendocrine cancer.
Plain-language title generated from the registry record
Registry title: Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases
Key facts
- Where
- São Paulo, BrazilSee the site
- Phase
- Phase 2
Where in Brazil
- Instituto do Câncer do Estado de São PauloSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Sao Paulo
- Trial code
- NCT02185443
- Record updated
- 9 December 2024
- Original description
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.Read full original descriptionShow less
Stereotactic Body Radiation Therapy for the Treatment of Unresectable Liver Metastases in Patients With Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors
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.
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; 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; Pregnancy; Underlying Cirrhosis; Severe Comorbidity; Current anticoagulant treatment.