Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

University of Sao Paulo

Status and phase

Enrolling

Phase 2

Conditions

Anal Canal Cancer

Liver Metastases

Gastrointestinal Neuroendocrine Tumors

Colorectal Cancer

Treatments

Radiation: SBRT

Study type

Interventional

Funder types

Other

Identifiers

NCT02185443

RT-01/2014

Details and patient eligibility

About

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.

Enrollment

43 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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