Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

December 4, 2024 updated by: Andre Tsin Chih Chen, University of Sao Paulo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01246-000
        • Recruiting
        • Instituto do Cancer do Estado de Sao Paulo
        • Contact:
        • Sub-Investigator:
          • Karina Moutinho, MD
        • Sub-Investigator:
          • Rachel Riechelman, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT
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
Other Names:
  • Stereotactic Body Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Instituto do Cancer do Estado de São Paulo

Investigators

  • Principal Investigator: Andre TC Chen, MD, PhD, Instituto do Cancer do Estado de Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimated)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT-01/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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