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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
* 60Gy in 3 fractions (20Gy/fraction) over 14 days * 60Gy in 5 fractions (12Gy/fraction) over 18 days if organ at risk constraints cannot be met with fractionation above
Instituto do Cancer do Estado de São Paulo
São Paulo, São Paulo, Brazil
RECRUITINGLocal Progression Free Survival
\- Local Progression Free Survival of treated lesions in evaluable patients. Local Progression Free Survival will be defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria applied to the Planning Target Volume (PTV) and 1cm around (assessment of marginal failure). Time-to-events will be counted from the date of initiation of treatment. Patients will be considered evaluable if followed for at least 6 months after SBRT. A review after 6 months is due to the transient changes after irradiation that make uncertain radiological evaluation before 6 months.
Time frame: 2 years
Overall Survival
Time frame: 5 years
Progression Free Survival
Time frame: 5 years
Toxicity
treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4
Time frame: 5 years
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