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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

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

NCT ID

NCT02185443

First Posted

July 4, 2014

Last Updated

December 15, 2021

Sponsor

University of Sao Paulo

Collaborators

Instituto do Cancer do Estado de São Paulo

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

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

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

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

andre.chen@hc.fm.usp.br

First Name & Middle Initial & Last Name or Official Title & Degree

Karina Moutinho, MD

Phone

55-11-3893-4542

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

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

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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