Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

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: Colorectal Cancer; Liver Metastases; Anal Canal Cancer; Gastrointestinal Neuroendocrine Tumors
• Intervention / Treatment: Radiation: SBRT

• Study Type: Interventional
• Enrollment (Estimated): 43
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Andre TC Chen, MD, PhD; Phone Number: 55-11- 3893-4540; Email: andre.chen@hc.fm.usp.br
• Study Contact Backup: Name: Karina Moutinho, MD; Phone Number: 55-11-3893-4542; Email: kamoutinho@gmail.com

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 01246-000
      • Recruiting
      • Instituto do Cancer do Estado de Sao Paulo
      • Contact: Andre TC Chen, MD; Phone Number: 55-11-3893-4540; Email: andre.chen@hc.fm.usp.br
      • Sub-Investigator: Karina Moutinho, MD
      • Sub-Investigator: Rachel Riechelman, MD, PhD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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

Collaborators and Investigators

• 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

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 (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: radiation; SBRT; Colorectal Neoplasms; Neuroendocrine Tumors; Neoplasm Metastasis; Anal Canal
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Liver Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Intestinal Diseases; Neoplastic Processes; Pancreatic Diseases; Stomach Neoplasms; Neoplasm Metastasis; Pancreatic Neoplasms; Liver Neoplasms; Neuroendocrine Tumors; Intestinal Neoplasms
• Other Study ID Numbers: RT-01/2014