Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

Sponsor

University of Sao Paulo (Other)

Overall Status

Recruiting

CT.gov ID

NCT02185443

Collaborator

Instituto do Cancer do Estado de São Paulo (Other)

Enrollment

Location

Arm

120

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Metastases Colorectal Cancer Anal Canal Cancer Gastrointestinal Neuroendocrine Tumors	Radiation: SBRT	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2014

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Local Progression Free Survival [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 Outcome Measures

Overall Survival [5 years]
Progression Free Survival [5 years]
Toxicity [5 years]
treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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