Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

Phase 2

Recruiting

• Conditions: Colorectal Cancer; Anal Canal Cancer; Gastrointestinal Neuroendocrine Tumors; Liver Metastases
• Interventions: Radiation: SBRT

• Registration Number: NCT02185443
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT	SBRT	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Instituto do Cancer do Estado de São Paulo; 🇧🇷 São Paulo, SP, Brazil