Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

  • STATUS
    Recruiting
  • End date
    May 21, 2024
  • participants needed
    43
  • sponsor
    University of Sao Paulo
Updated on 22 December 2021
carcinoma
liver disease
metastasis
neutrophil count
liver metastasis
blood transfusion
primary tumor
stereotactic body radiation therapy
systemic chemotherapy
adenocarcinoma
colorectal adenocarcinoma
neuroendocrine tumor

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.

Details
Condition Liver Metastases, Colorectal Cancer, Anal Canal Cancer, Gastrointestinal Neuroendocrine Tumors
Treatment SBRT
Clinical Study IdentifierNCT02185443
SponsorUniversity of Sao Paulo
Last Modified on22 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Karnofsky Performance Scale (KPS) equal or greater than 70
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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