Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02185443

Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

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.

Recruiting

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SBRT

Radiation
  • 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

Other names: Stereotactic Body Radiation Therapy

Primary outcomes

  1. Local Progression Free Survival

    Time frame: 2 years

    • 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.

Secondary outcomes

  1. Overall Survival

    Time frame: 5 years

  2. Progression Free Survival

    Time frame: 5 years

  3. Toxicity

    Time frame: 5 years

    treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4

Study contacts

Contact information is provided by the study sponsor or research team.

Andre TC Chen, MD, PhD

CONTACT

[email protected]

55-11- 3893-4540

Karina Moutinho, MD

CONTACT

[email protected]

55-11-3893-4542

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Instituto do Cancer do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2014
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.