Clinical Trial Finder

Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02185443
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Sao Paulo
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Andre TC Chen, MD, PhD
Principal Investigator Affiliation Instituto do Cancer do Estado de Sao Paulo
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Brazil
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Liver Metastases, Colorectal Cancer, Anal Canal Cancer, Gastrointestinal Neuroendocrine Tumors
Arms & Interventions

Arms

Experimental: SBRT

Interventions

Radiation: - SBRT

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

São Paulo, SP, Brazil

Status

Recruiting

Address

Instituto do Cancer do Estado de São Paulo

São Paulo, SP, 01246-000

Site Contact

Andre TC Chen, MD

[email protected]

55-11-3893-4540

Powered By

Stay Informed & Connected