Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Liver Metastases, Colorectal Cancer, Anal Canal Cancer, Gastrointestinal Neuroendocrine Tumors

Intervention / Treatment
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* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT<br> | Radiation: SBRT<br>* 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<br>* Other names: Stereotactic Body Radiation Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 5 years | 
| Progression Free Survival |  | 5 years | 
| Toxicity | treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SBRT, radiation, Neoplasm Metastasis, Colorectal Neoplasms, Anal Canal, Neuroendocrine Tumors