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Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

Primary Purpose

Liver Metastases, Colorectal Cancer, Anal Canal Cancer

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
SBRT
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastases focused on measuring SBRT, radiation, Neoplasm Metastasis, Colorectal Neoplasms, Anal Canal, Neuroendocrine Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Instituto do Cancer do Estado de São PauloRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT

Arm Description

Outcomes

Primary Outcome Measures

Local Progression Free Survival
- 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 Outcome Measures

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

Full Information

First Posted
July 4, 2014
Last Updated
December 15, 2021
Sponsor
University of Sao Paulo
Collaborators
Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02185443
Brief Title
Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Instituto do Cancer do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastases, Colorectal Cancer, Anal Canal Cancer, Gastrointestinal Neuroendocrine Tumors
Keywords
SBRT, radiation, Neoplasm Metastasis, Colorectal Neoplasms, Anal Canal, Neuroendocrine Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBRT
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
SBRT
Other Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Local Progression Free Survival
Description
- 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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
5 years
Title
Progression Free Survival
Time Frame
5 years
Title
Toxicity
Description
treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andre TC Chen, MD, PhD
Phone
55-11- 3893-4540
Email
andre.chen@hc.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Karina Moutinho, MD
Phone
55-11-3893-4542
Email
kamoutinho@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre TC Chen, MD, PhD
Organizational Affiliation
Instituto do Cancer do Estado de Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Cancer do Estado de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre TC Chen, MD
Phone
55-11-3893-4540
Email
andre.chen@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Karina Moutinho, MD
First Name & Middle Initial & Last Name & Degree
Rachel Riechelman, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

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